Jobs That Crossed My Desk Through August 25, 2013 Complimentary Service of Audreysnetwork.com

August 25, 2013

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org.

*************************************************************************** http://www.linkedin.com/jobs2/view/6655680?trk=job_view_browse_map Regional Sales Manager – Life Science and Dx Tools Fluxion Biosciences - San Francisco Bay Area

Experience Mid-Senior level

Job function Sales, Science

Employement type Full-time

Industry Biotechnology

Job ID 6655680

Other Details About this job Job description This is an excellent opportunity for someone currently serving as a district/regional sales professional who wants to continue excelling in direct sales but also broaden their exposure and responsibility to include sales strategy, distributor/channel management, and international sales. Location: This position will be based out of Fluxion’s South San Francisco, CA headquarters. Consideration will be made for exceptional candidates that are based out of other key geographies. Fluxion is currently looking for an experienced Regional Sales Manager to lead the commercialization effort for the recently-launched IsoFlux System. This position is an excellent opportunity for an experienced sales professional to take on a significant role in the rapid

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commercial growth of a new instrumentation platform that will have a major impact in the field of cancer diagnostics. The successful candidate will be a natural ‘closer’ and contribute to both sales and business development activities as well as serving as a sales liaison to the project and management teams. This high visibility position will focus on the commercial adoption of the IsoFlux System within university, research center, biopharma, and clinical lab sites. The ideal candidate will have a background in sales and business development in the life science tools and diagnostics industry. A strong, verifiable track record of closing sales opportunities and exceeding projections is imperative for this role. This is a consultative sales role – the ideal candidate will able to maintain a high degree of technical knowledge and interact with high level customers across a variety of institutions. Fluxion Biosciences is a rapidly-growing bioanalytical tool company that is addressing critical needs in the pharmaceutical, biotech, diagnostics, and life science research markets. We are looking for individuals who will thrive in a fast-paced environment and can make meaningful contributions to the development and commercialization of our line of products for cellular analysis. Fluxion offers competitive salary, stock options, and a comprehensive benefits package (health, dental, vision, FSA, and more). The Sales Manager will: Maintain responsibility for hitting the sales targets of the IsoFlux System, both in the US

and internationally Manage the sales pipeline by accurately tracking sales opportunities according to

customer segment and progression towards closing Pursue sales prospects coming from a variety of sources (marketing and business

development activities) by offering sales presentations, technical consultations, evaluations, etc.

Work closely with the product and technical teams (field and in-house application scientists) to address customer inquiries and product evaluations

Conduct negotiations surrounding purchase orders, placements, etc. and ensure timely closing of opportunities

Analyze the key metrics surrounding progression of sales opportunities and be prepared to make recommendations to optimize the sales cycle and product positioning

Work closely with Fluxion’s network of international distributors to maintain sales targets in their geographies and close individual sales opportunities

Identify new areas of commercial growth for the existing IsoFlux product and make recommendations for future product development

Represent the product and company at US and international conferences and trade show exhibits

Identify and pursue sales and business development channels beyond single institution sales, including: OEM, private label, CRO/Reference Lab, and Dx partnerships

To Apply: Please send Cover Letter and Resume using LinkedIn or to mike.schwartz@fluxionbio.com (please include “Regional Sales Manager” in subject so it gets properly identified) Desired Skills and Experience Bachelors level degree in the biological sciences or engineering (MS, MBA, or Ph.D. preferred) A MINIMIUM of 3 full years of post-graduate experience with a life science tools or diagnostics

company A MINIMUM of 2 full years of experience in a direct sales role for instrumentation / capital equipment

(>$10K) with ownership of territorial or product sales number Additional experience in marketing, business development, and/or product development preferred Direct experience as a sales professional with a company in any of the following areas:

Oncology diagnostic instrumentation Biomarker testing / diagnostics

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Sequencing instrumentation or reagents qPCR / dPCR / multiplexed PCR instrumentation or reagents Pathology / microscopy instrumentation Ability to work both independently and within the team structure, good teamwork attitude a

must Ability to work in a fast paced and changing environment Flexible and quickly adaptable to changing priorities Excellent written and oral communication skills and meticulous record keeping Experience with sales CRM platforms (Salesforce preferred)

Moderate travel (20-40%) required to cover customer visits, conferences, and international distributors

About this company

Fluxion Biosciences

Fluxion delivers advanced systems that automate complex cellular assays. Products include the IsoFlux system for circulating tumor cell analysis, the BioFlux system for functional analysis of cellular interactions, and the IonFlux automated patch clamp system. Hundreds of labs globally rely on Fluxion's solutions to research novel biology, accelerate drug discovery, and tailor therapies based on patient-specific biomarkers.

************************************************************************** Posted by Adriana Petersen, Executive Search for Life Technologies http://www.linkedin.com/jobs2/view/6924267?trk=eml-anet_dig-b_premjb-ttl-cn Leader (Director level) - Market Development - Human Identification Life Technologies - South San Francisco

Experience Executive

Job function Marketing

Employement type Full-time

Industry Biotechnology

Job ID 6924267

Committed to hiring veterans Other DetailsAbout this job Job description The Market Development Leader serves as leader of the HID Global Market Development team, driving the marketing initiatives across multiple product lines and applications, including instrumentation, consumables, application specific kits and software, and/or strategic target markets. Contributes to the comprehensive business unit marketing plan to help achieve fiscal sales, marketing, and revenue goals globally. Works on strategic marketing plans for areas of responsibility by proposing, developing,

and executing detailed tactical program plans for campaigns supporting global regions.

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Ensure alignment of program plans among Market Development Managers, Product Managers and Regional Marketers, among other stakeholders.

Responsible for creation as well as region-specific deployment of disruptive Marketing approaches as well as viral marketing tools, so as to target awareness across the world and create a massive base for lead generation.

Ensure production of marketing materials described in marketing plans including, but not limited to: collateral, flyers, application notes, direct mail, eMarketing / Web. Act as project lead and liaison to internal and outside vendors, maintaining excellent professional relationships in order to facilitate the conversion of marketing ideas and messages into effective marketing materials and sales tools.

Develop and execute global marketing programs, including, but not limited to, product launches and sustaining programs described in marketing plans by development of appropriate sales tools.

Desired Skills and Experience Strong business acumen and understanding of the "big picture" Experience working across a complex organization in a matrix environment Track record of success leading people and business Experience in developing and deploying global integrated marketing programs. Experience with biotech and /or life sciences industry and related products in

sequencing and real-time PCR Experience developing & conducting product training for a wide variety of audiences,

including sales teams, regional marketing and customers Writing and editing skills, particularly for communicating scientific information,

applications, and articles of interest, accurately and appropriately to different target customer segments, including Scientific Buyers, Influencers, and Users

7 years of experience in similar positions in the field of forensics, genomics, molecular biology, or molecular diagnostics.

Developing and conducting market assessment surveys (e.g. kano, conjoint) Experience in selecting marketing methods and techniques Balancing process orientation with an appreciation for deliverables. Master’s or PhD in Biology, Genetics, Molecular Biology, Chemistry or a related field of

study. Bachelor’s degree plus 10+ years of experience may also be accepted. ************************************************************************ Apply on company website Home Based: Medical Director (Physician): Cardio– Serelaxin (Western US): Top Pharma Co: Major Cardio Drug Development [RETAINED SEARCH] Cornerstone Search Group - San Diego, CA (Covering west of Mississippi) work from home

Experience Executive

Job function Research, Other, Science

Employement type Full-time

Industry Biotechnology, Pharmaceuticals

Employer job ID srBH2088li

Job ID 6468161

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Job description Summary: This is a key full-time position where you will be an employee of this Top 5 Global Pharmaceutical Company working on one of their largest and highest profile Clinical Development Programs for a new cardiovascular drug to treat Heart Failure. This is a key position critical to the success of the overall Clinical Development Program for this CV/Heart Failure drug. Work closely in the field with Hospitals, PIs and KOLs, regarding multiple medical, safety enrollment, and patient matters. Company Description: One of the most successful Global Top Pharmaceutical Companies that also has the richest and most extensive development pipeline in multiple therapeutic areas in the entire Pharmaceutical Industry. Location: Work from home– must be located west of the Mississippi and will cover the Western United States. Attractive Features about this Opportunity Be part of a team working on a very large, high profile cardiovascular / critical care

clinical trial (registration trial) Work closely with key PIs and KOLs Work from your home office and travel to sites and corporate headquarters as needed Join one of the most successful Pharma Companies in the World with the richest drug

development pipeline in the industry Responsibilities In a nutshell, for your assigned region, you will be the key contact for important PIs and KOLs involved with a very large, important and critical CV drug development program. This will include, but not be limited to: communicating/meeting with PIs and KOLs regarding clinical protocols, drug safety (AEs/SAEs), risk management, patient recruitment & inclusion/exclusion criteria, medical matters/issue. Also, you will work closely with Global Program Team Members based in the US and in international locations as well. Requirements/Qualifications/Experiences: MD degree 5 or more years of industry Clinical Development/Operations experience In-patient ICU/CCU critical-care clinical study/trial experience (ER setting where you are

dealing with a fast-moving patient situation and potentially multiple Physicians involved with the patients care). Obviously, this presents patient recruitment/enrollment challenges in this type of environment.

Feasibility studies: planned and conducted site multiple site feasibility studies/visits CRO experience where you have dealt directly and/or managed CRO resources Clinical Operations experience where you have dealt directly with the Clinical Operations

people/team on clinical studies/trials Confidentiality/privacy All inquiries and submissions are held in strict confidence, i.e. no information provided to us by you will be shared with any parties outside of Cornerstone Search Group without your permission to do so. Steven Raz | Co-Founder & Managing Partner U.S. Number: +1 973 656 0220 ext. 712 | sraz@cornerstonesg.com Basel, Switzerland Local Number: +41 61 508 7010 www.linkedin.com/in/stevenraz Cornerstone Search Group, LLC Life Sciences Executive Search 6 Campus Drive | Parsippany, NJ 07054 Our Open Positions:http://cornerstonesg.com/Search_Jobs_Results.aspx Keywords: Work at home, Home Based, Cardio, Cardiovascular, Critical Care, Heart, AHF, Acute Heart Failure, Stroke, ER, Emergency Medicine, Novartis, Serelaxin, MD, Medical, Physician, West Coast

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Desired Skills and Experience Requirements/Qualifications/Experiences: MD degree 5 or more years of industry Clinical Development/Operations experience In-patient ICU/CCU critical-care clinical study/trial experience (ER setting where you are

dealing with a fast-moving patient situation and potentially multiple Physicians involved with the patients care). Obviously, this presents patient recruitment/enrollment challenges in this type of environment.

Feasibility studies: planned and conducted site multiple site feasibility studies/visits CRO experience where you have dealt directly and/or managed CRO resources Clinical Operations experience where you have dealt directly with the Clinical Operations

people/team on clinical studies/trials ************************************************************************ Posted by Lucy (Jinglucy) Sun, Scientist | Project management | Customer-focus | Assay Development http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=268235539&gid=3412079&trk=eml-anet_dig-b_jb-ttl-cn&fromEmail=&ut=2hfERzQz76iBU1 Bio-RAD: Field Applications Specialist/Tactical Applications Laboratory Manager Location: Hercules, CA (SF Bay Area) If you are interested, I can connect you with the hiring manager for the job. Job Description: The Technical Support Group has a challenging career opportunity for a talented and highly-motivated individual who would like to apply their scientific acumen and technical skills to support Bio-Rad’s Life Science internal and external customers in North America. The successful candidate will be expected to develop rapidly into a subject matter expert on both the Bio-Plex (otherwise know as Luminex xMAP) technology and Bio-Rad’s Next Generation Chromatography (NGC) Systems and to provide support to customers, as well as Bio-Rad’s sales representatives and Regional Field Application Specialists who are based across the US and Canada. The chosen applicant will also be expected to interact regularly with multiple in-house groups who play a key role in supporting these product lines, including Technical Support, Marketing, R&D, Manufacturing and Quality Control (QC). Travel Requirements for this position are 25-50%. Job Duties: • Provide pre- and post-sales trainings or presentations to customers on Bio-Plex Systems and Assays, or NGC Systems. • Act as a technical consultant for Bio-Rad sales representatives and Regional Field Application Specialists on the Bio-Plex and NGC product lines. • Provide assistance to Technical Support in troubleshooting customer issues which cannot be resolved by phone or email. Examples might include running an instrument, or performing an assay with the customer at their site, or testing customer samples in-house. • Design and execute training curriculums for customers, sales representatives, or Regional Field Application Specialists on Bio-Plex or NGC products. • Design and execute comparison studies between Bio-Rad and competitor products in support of Marketing and R&D efforts. • Generate technical data, quick guides, or other informational material to address common

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customer FAQs. Work with Marketing on sales collateral. • Maintain and manage the Tactical Applications Laboratory (TAL). Keep inventory of equipment and ensure equipment is operational and lab is stocked appropriately for trainings, or other activities which someone in this position will need to perform in the lab. • Attend New Product Development (NPD) and Quality Meetings to provide first-hand feedback and insight into customer needs, requirements, or issues. • Act as an internal “beta” tester for software, products, kits in the Bio-Plex, or NGC product lines. Required Experience: • Ph.D. in Molecular Biology, Immunology, Cell Biology, Biochemistry, or equivalent discipline. • Hands-on experience with ELISA and Western blot essential. Experience with Bio-Plex or Luminex xMAP technology a definite plus. • Hands-on experience with Lab Scale Chromatography Systems. Experience with HPLC/FPLC. • Excellent communication and presentation skills. • Good laboratory technique, attention to detail and problem-solving skills. • Field experience a plus. ************************************************************************ Contact the job poster Reach out for more information or to follow up on your application Cynthia Grant Cynthia@GrantProSearch.com Neurology Sales Specialist GrantProSearch - Santa Monica/Beverly Hills, CA Posted 1 day ago Apply nowSavedUnsaveSave

Experience Mid-Senior level

Job function Sales

Employement type Full-time

Industry Pharmaceuticals

Job ID About this job Job description Leading pharmaceutical organization seeks specialt ypharmaceutical sales representative to sell company products to Neurologists/Psychartist. Territory is Santa Monica/Beverly Hills. Client prefers candidates that have current experience calling on Neurologists,CNS experience. Client is a top pharmaceutical organization that is one of few that has not seen lay offs! Desired Skills and Experience BA/BS required 3-8 years of extremely successful pharmaceutical sales experience Neurology sales experience preferred Solo peformance preferred Must have documented sales success Must be articulate and very driven Must be able to passionately describe sales successes Must have stable work environment

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Must live in the territory About this company GrantProSearch GrantProSearch assists healthcare companies; pharmaceuticals, bio-technical, medical diagnostics, medical device, hospitals and clinics as well as partnering with start up organizations for their professional staffing needs. Each search is treated individually with the knowledge and expertise of your market segment. GrantProSearch team members devote the requisite time in identifying qualified candidates who meet the specific criteria of each client. GrantProSearch's objective is to ensure the candidate’s interest and excitement about your opportunity. We understand our client’s need to select from a narrow list of professional candidates quickly so that they can reduce their hiring costs. We are a certified member of the Women's Business Enterprise National Council. And we serve as a board member on First Interview Company, a network of over one hundred and twenty healthcare industry recruitment firms. ************************************************************************ http://www.bullhornreach.com/job/996964_diabetes-sales-specialist-byettasymlin-santa-barbara-ca?utm_campaign=v1&shortlink=2655845&utm_content=5&utm_source=linkedin.com&referer=www.linkedin.com&utm_medium=referral Diabetes Sales Specialist (Byetta/Symlin) This position is for a professional sales representative for the Diabetes sales team within the DS3 Diabetes Specialty Division at Bristol-Myers Squibb. The position is located in Santa Barbara, CA. Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines. Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals. An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), medical group practices, hospitals, pharmacists, nurses, office staff and other health care providers in the patient care continuum. Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time. Bachelor's degree or equivalent is required. Proven track record in customer service industry is required along with 2 years of sales related experience. Demonstrated success in medical related sales advantageous. A strong customer focus and analytical skills to identify and prioritize business opportunities is required. Proven track record in delivering results and developing innovative approaches in evolving markets. Previous new product or concept launch experience desired. Ability to learn, apply, and grow disease state knowledge required. ********************************************************************* https://jobs.smartbrief.com/action/listing?listingid=E5B7970B-E79F-44C0-9A87-C1BC8ABC26F1&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 HEALTH CARE COMPLIANCE OFFICER

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Johnson & Johnson Job Description HEALTH CARE COMPLIANCE OFFICER (Job Number:0591130616) Description: Johnson & Johnson is looking for an HCC Officer for Acclarent Inc located in Menlo Park, California and Cordis Corporation located in Fremont California. The companies are part of the Johnson & Johnson family of companies in the Medical Device sector. This Officer position will provide HCC support and oversight for both companies. Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. Acclarent is a medical technology company dedicated to designing, developing and commercializing technologies that address conditions affecting the ear, nose and throat. The company was founded in 2004, was acquired by J&J in 2010. It is a growing company currently with about 350 employees, a US sales organization of about 150, and worldwide sales of approximately $200MM. Cordis Corporation is relocating the company's headquarters to Fremont, California. Cordis is a pioneer in less invasive treatments for vascular disease specializing in interventional medical procedures in cardiovascular, endovascular, and biliary duct (liver) treatments. Cordis sales are approximately $840MM worldwide with about 700 employees and a US sales organization of 225 people. As HCCO, the person in this position will serve as the HCC Officer for both Acclarent and Cordis providing support for the management boards, chairing its HCC Committees, and providing compliance support for key headquarters functions. HCC officers implement and maintain programs that support compliance with HCC laws, regulations and industry standards related to the promotion and marketing of health care products and services, interactions with health care professionals and/or government officials, including, as applicable to the business activities, FCPA and other anti-corruption laws, off-label promotion, anti-kickback and false claims statutes, compliance with corporate integrity agreements, deferred prosecution agreements or other settlements. The HCCO partners with company leadership (sales, marketing, R&D, HR, etc.,) to implement and maintain that Health Care Compliance programs that prevent and/or detect violations of law, regulations, and company policies. He/she will be acting as a consultant, reviewer and approver as needed, for business activities that involve HCC risks. This individual will be providing appropriate guidance, education, training, and regular communications on HCC to all relevant employees. He/she will support the risk assessment process, testing & monitoring efforts, external audits and reviews, corrective actions, response to reports of potential misconduct, and other elements of the companies' compliance programs. The Acclarent and Cordis HCCO will provide strategic support to senior management at the business units regarding potential compliance risks, compliance-related incidents and investigations, and trends, root causes, and recommend and implement appropriate action plans. He/she will participate in cross-company or cross-sector compliance initiatives within J&J, as necessary, and provide support to J&J HCC senior management. This individual will interface with legal counsel regarding HCC requirements and interpretation. The HCCO will partner with colleagues within the Global Surgery Group and J&J HCCP to drive the adoption of more efficient or effective HCC related practices. This individual will support the efficient implementation of the US Sunshine Act reporting obligations, and will analyze metrics at the operating company level and provide analysis to Global Surgery Group Leader and others as appropriate. The Acclarent and Cordis HCCO will manage a HCC Manager and have dotted line management of a second HCC manager who support the HCC programs at each operating company. This role includes actively engaging in the enterprise-wide Talent Management process for HCC to include establishing goals and objectives, giving direction, support, and periodic feedback to

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direct reports pursuant to Human Resources policies. He/she will provide technical subject matter expertise, advice and development opportunities to direct and indirect reports. Qualifications: A minimum of a Bachelors Degree is required. A minimum of 6 years of business experience, with at least five years in health care compliance, government contracts compliance or related compliance area is required. Current status as a Certified Compliance & Ethics Professional (CCEP®) or Certification in Healthcare Compliance (CHC®) preferred. Knowledge of healthcare fraud and abuse, anti-corruption and false claims laws is required. Knowledge of laws and regulations governing health care reimbursement is required. Knowledge of laws and regulations concerning the marketing and promotion of medical devices is required. Knowledge of financial or auditing practices is required. Knowledge of current standards and guidance concerning corporate compliance and ethics programs is required. Demonstrated experience in the development and implementation of a compliance program in accordance with the organization's risk profile is required. Exceptional written and verbal communications skills are required. Experience with project management in a matrixed business organization is preferred. Strong communication skills, organizational skills, and analytical skills are required. Broad business experience and a proven ability to influence business decisions and business partners are required. Ability to think strategically, develop and execute longer-term objectives is required. Ability to take complex business situations and develop solutions that ensure compliance is required. Proven track record in delivering results, self starter and ability to manage complexity is required. Ability to work well between functions and across all levels of the business and effective negotiating skills is required. Ability to comprehend and interpret legal documents is preferred. Proven success at managing and developing talent is required. This position will be located in Menlo Park, CA and Fremont, CA and will require up to 20% travel. Primary Location: North America-United States-California-Fremont Other Locations: Organization: Johnson & Johnson (6067) Job Function: Health Care Compliance ********************************************************************** Major med device Silicon Valley leader seeks talent in global product mgmt; customer segment marketing mgmt; business channel development; and product marketing mgmt. Contact me: ldesio@msn.com If you or your talented colleagues are interested, contact me (ldesio@msn.com) for further information. Will provide your information to Manager internal to orgn. ********************************************************************** http://www.linkedin.com/jobs2/view/6624339?trk=eml-anet_dig-b_premjb-ttl-cn Project Manager Planet Pharma - San Francisco Bay Area

Experience Mid-Senior level

Job function Consulting

Employement type Contract

Industry Pharmaceuticals, Biotechnology

Job ID 6624339

Other Details About this job

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Job description Ensure improvement methodology and tools are utilized effectively to maximize benefits . Deliver project goals on budget and on schedule . Develop conceptual customer needs into an approved project charter . Analyze business, process and systems performance, and identify improvement opportunities . Develop, evaluate and manage business case and cost/benefit analyses . Provide decision support and recommendations to select best options . Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution . Develop and use project plans to coordinate participants and track and report progress . Leverage industry research and analysis; serve as advocate & role model for integrating best practices into the organization . Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals Desired Skills and Experience Collaborative Leadership- Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity, able to create order from chaos. Ownership and Accountability . Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted . delivers of promises, goals, and expectations. Makes quality decisions and resolved problems rapidly. Communication-Ability to communicate effectively up and down, at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity. Planning/Organization-Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amount of information. Able to deliver results despite nshifting environment. Analytical Problem Solving . Ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution. Education: BS/BA (Engineering/Science preferred). Minimum 7 years of related analytical and business experience working in a complex. Manufacturing and/or Engineering environment (biotech/pharmaceutical industry or familiarity with cGMP's a plus). Minimum 3 years Project Management experience. Experience with implementation of process improvement initiatives

About this company Planet Pharma Following companyUnfollow companyFollow company Company Overview: Planet Pharma was founded by a seasoned group of professionals with over 50 years of Clinical & Scientific staffing and outsourcing experience and is one of the first “Green Staffing Companies” in Illinois. Through the use of cutting-edge technology and a service delivery model based on a paperless work environment, Planet Pharma can make an immediate impact for your Pharmaceutical, Biotechnology or Medical Device organization. We provide the following solutions: Contact Staffing, Outsourced Projects, Permanent Placement and Managed Service Provider Specialities: Clinical & Scientific Staffing, Technology Staffing, Site Management & Monitoring, Clinical Project & Program Management, Clinical Programming & Data Management, Biostatistical Analysis & Reporting, Pharmacovigilance, Medical Writing, Regulatory Affairs, Quality Assurance and Validation. Planet Pharma is headquartered in Chicago, IL and has a regional office in Cleveland, OH.

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Website: http://www.planet-pharma.com ******************************************************************* APPLY TODAY Please apply via this website, via our website at www.McKesson.com/careers or send your resume directly to wendi.mclane@mckesson.com. Senior Program Manager (EHR/Meaningful Use) - 74534 McKesson - The Woodlands Posted 2 days ago Apply nowSavedUnsaveSave

Experience Mid-Senior level

Job function Product Management

Employement type Full-time

Industry Hospital & Health Care

Employer job ID JD 74534

Job ID 6744706

Other Details About this job

Job description Senior Program Manager, Enabling Technology POSITION OVERVIEW Program Manager will coordinate and drive the various groups, stakeholders and client activities across multiple stakeholder interests to accomplish strategic initiative objectives and deliverables. This individual will serve as subject matter expert and driver of key programs that align with strategic initiatives. The program manager will also help define and drive the project schedule, and be responsible for the overall program, deadlines, and be expected to define and deliver on program expectations. 74534 Initial strategic program focus will primarily be Meaningful Use and PQRS. More than 1000 providers plus their clinical and administrative support staff will be impacted by Meaningful Use and PQRS equating to $40M+ in potential incentives to physicians and $50M+ in penalty avoidance at minimum over the life of Meaningful Use. To lead this change over the lifespan of Meaningful Use, McKesson Specialty Health needs a strong leader well versed in program and change management, technology adoption, and process design in a clinical environment. Meaningful Use program core goal is to sustain and ideally improve current Stage performance while creating and deploying methodology to successfully prepare for and execute future Stages. RESPONSIBILITIES Leads strategic programs through collaboration, communication, and the

creation/execution of integrated work plans. Revises approach as appropriate to meet changing needs, requirements and strategic goals.

Manages day-to-day operational aspects of programs and scope. Develops and manages delivery of program tools, methodology, metrics, and services while staying under the department budget. Identifies resources needed and assigns individual responsibilities in coordination with management.

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Delivers methodology to meet practices’ need to improve quality, workflow & performance; while realizing through program success gains in patient service, value of technology, and financial benefit. Provides educational information and materials for trainers and stakeholders/customers

Provides program coaching and support to The US Oncology Network and open market practices, while also coaching others resources to help support practices. Facilitates and conducts events to support strategic initiatives and ensures program documentation is complete, current, and stored appropriately for stakeholders to access.

Assists various product stakeholders with products needed to successfully achieve strategic initiatives. Advises on reporting and product (e.g. EHR, portal, MU reporting, etc.) development, training support, and process design; for example, translating EHR certification into objective focused workflow.

Identifies business development and "add-on" service opportunities as needed. Manages relationships and contracts with outsourcing groups to deliver services/training, as needed.

Desired Skills and Experience QUALIFICATIONS / MINIMUM REQUIREMENTS Education/Training 4-year degree in related field or equivalent experience Equivalent experience: Seven to ten years increasingly responsible experience in

project management or product management experience Business Experience 8+ years experience working in healthcare Thorough knowledge of healthcare initiatives and company's products; ability to collect

and analyze market trends and customer needs Experience managing multi-disciplinary projects or programs Exposure to Meaningful Use , PQRS or other programs Experience in driving adoption of technology; specifically ambulatory EHRs, portals,

quality measurement systems and reporting tools Specialized Knowledge/Skills Strong knowledge of clinical and operational processes (oncology experience is ideal) Ability to write and support training documents Solid communication skills Experience with MS Project and MS Office Suite Working Conditions Can be remote based Travel up to 50% - on site with clients, medical society meetings and trade shows

About this company McKesson ABOUT McKESSON Making a difference starts with you. It can be as simple as helping a customer or as complex as creating lifesaving technology. When you work with McKesson, you initiate a chain of events that results in millions of people getting more from their healthcare. As the nation’s leading healthcare services company, we touch virtually every aspect of healthcare. We empower our customers by delivering vital supplies and solutions. And we empower all 32,000 of our employees through a collaborative environment that supports employee network groups and diversity councils. In our inclusive community, opportunity and responsibility grow. At McKesson, we believe we can empower healthcare. And it all starts with you. *************************************************************************

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https://jobs.smartbrief.com/action/listing?listingid=DFC959F2-A24C-4A69-B042-3BCCF5CADD51&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Director Regulatory Affairs - Operations - 13000005VB Abbott Job Description Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: Strategic Planning: • Identify need for new regulatory policies, processes and SOPs and approve them • Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture • Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle • Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions • Develop global regulatory strategies and update based upon regulatory changes • Conduct regulatory due diligence for potential and new acquisitions and advise management • Sets quality and accuracy standards • Anticipate emerging issues and develop solutions to them • Develop solutions to address issues with other members of management and stakeholders • Develop corporate positions on regulatory risk-benefit • Create and develop product positioning strategies based upon regulatory requirements • Integrate regulatory considerations into the corporation’s global product entry and exit strategy • Recruit, develop, and mentor regulatory professionals • Provide guidance for resource and development planning • Participate in applicable trade association/industry working groups to influence policy/rule making in alignment with business strategies Premarket: • Communicate application progress to internal stakeholders • Negotiate with regulatory authorities during the development and review process to ensure submission approval • Provide strategic input and technical guidance on regulatory requirements to development teams • Ensure preapproval compliance activities are completed • Formulate company procedures to respond to regulatory authority queries Postmarket: • Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests • Ensure a system is in place to manage access to information requests • Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance • Ensure crisis management program implemented and functioning • Identify and present option for risk mitigation to decision makers • Represent regulatory affairs in product recall and recall communication process • Ensure adverse events are reported to regulatory agencies and internal stakeholders • Manage processes involved with maintaining annual licenses, registrations, listings and patent information

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• Ensure compliance with product postmarketing approval requirements • Review and approve advertising and promotional items to ensure regulatory compliance • Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information Job specific responsibilities may include (choose applicable areas and expand as appropriate); • Medical writing • Advertising and promotion • Labeling • Controlled substances (e.g. DEA) • Restricted substances (e.g. REACH) • Compendial / standards • Import / export • Country specific regulatory support Influence/Leadership: • Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation. • Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectives. • Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units. • May lead a project team or initiative within department or cross-functions/divisions. • Provides technical leadership to business units. • Acts as a mentor to less-experienced staff internal and external to the department/division. • Exercises judgment independently. • Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives. • May participate / lead external industry working groups to influence advocacy in alignment with business strategies. Planning/Organization: • Creates mid- to long-range plans to carry out objectives established by top management. • Develops and calculates a budget for one or more departments to meet organizational goals. • Forecasts future departmental or group needs including human and material resources and capital expenditures. • Determines and establishes organizational structure and supervisory relationships subject to top management approval. Decision Making/Impact: • Assignments are expressed in the form of objectives • Work is performed without appreciable direction. • Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. • Consequences of erroneous decisions or recommendations would normally include delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity. Minimum Education Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs

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Professionals Society.) Minimum Experience / Training Required 7-10 years experience in a regulated industry (e.g., medical products, nutritionals). 7-10 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. Background / Skills / Knowledge Regulatory Knowledge of (as applicable): • Regulatory history, guidelines, policies, standards, practices, requirements and precedents • Regulatory agency structure, processes and key personnel • Principles and requirements of applicable product laws • Submission/registration types and requirements • GxPs (GCPs, GLPs, GMPs) • Principles and requirements of promotion, advertising and labeling • International treaties and regional, national, local and territorial trade requirements, agreements and considerations • Domestic and international regulatory guidelines, policies and regulations • Ethical guidelines of the regulatory profession, clinical research and regulatory process Technical/Business Knowledge of: • Monitor costs of projects and of human and material resources within a department or unit • Monitor company-wide indicators such as market share and profitability • Develop least cost, least time means to provide optimal regulatory support for new products • Monitor external environment in area of technical or professional responsibility • Direct and manage the preparation of technical strategic regulatory documentation for agency submission. • Understand of reimbursement Communication Skills or Ability to: • Communicate effectively verbally and in writing • Communicate with diverse audiences and personnel • Write and edit technical documents • Work with cross-functional teams • Work with people from various disciplines and cultures • Write and edit technical documents • Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies • Negotiate internally and externally with regulatory agencies and participate in political lobbying • Plan and conduct meetings • Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks • Effectively negotiate regulatory agreements with global regulatory agencies • Negotiate regulatory and scientific issues with management • Adjust presentation style and content to suit the audience Cognitive Skills or Ability to: • Pay strong attention to detail • Manage projects • Create project plans and timelines • Must be able to juggle multiple and competing priorities

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• Think analytically with good problem solving skills • Organize and track complex information • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results • Has broad knowledge of various technical alternatives and their potential impact on the business • Exercise good and ethical judgment within policy and regulations • Plan and implement most appropriate strategy to obtain product licensure in least amount of time worldwide • Use in-depth knowledge of business functions and cross group dependencies/ relationships • Define regulatory strategy • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues • Perform risk assessment or analysis • Counsel management on regulatory policies so as to maximize income, minimize competition, and minimize risk to business. • Develop and/or identifies new work processes that will have broad applicability throughout the company Lead functional groups in the development of relevant data to complete a regulatory submission *************************************************************************** Anyone interested please contact Sandy Huynh, Staffing Consultant, 650 372-7104 / sandy.huynh@gilead.com. Gilead is looking for a Research Scientist II - Bioinformatics (a PhD with 3+ years of experience in oncology ideally, R language is a must to analyze microarray and next generation sequencing data. Perl/Linux are good to have but not required). Please visit www.cbasf.org for detailed description. Other open positions are at the CBA site or sponsor sites such as www.gilead.com or www.alexza.com. ************************************************************************* Contact Person:Dario A. Paggiarino, MDEmail Address: info@Lpath.com Position Title: Project Lead, Development Date: July, 2013 Company Description: Lpath, Inc. is a San Diego based therapeutic antibody company, and the category leader in lipid-targeted therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath's ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company has developed three drug candidates: iSONEP™, a monoclonal antibody against sphingosine-1-phosphate (S1P), is currently in a Phase 2 trial for wet AMD; ASONEP™, also a monoclonal antibody against S1P, is in a Phase 2 clinical trial as a treatment for renal cell carcinoma; and Lpathomab, an antibody against lysophosphatidic acid, is a preclinical drug candidate that holds promise in pain, neurotrauma, and other diseases. Lpath entered into an agreement with Pfizer Inc. (NYSE: PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. For more information, visit www.Lpath.com. Position Summary:

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The candidate will lead early development projects to ensure project goals are met by organizing and implementing activities defined by project plans. Under the direction of the SVP and Chief Development Officer, the candidate will represent the single point of accountability for the individual early development project(s) from IND-enabling studies through Phase 2. The candidate will lead implementation of pre-clinical, clinical, regulatory affairs and project management activities through interaction with internal colleagues and/or external consultants and service providers to integrate project efforts across disciplines. A strong background in CMC operations in the area of biologics would be a plus. Job Requirements Specific Responsibilities & Duties:

Lead the development of one or more antibodies from IND-enabling studies through clinical PoC; specifically, lead—and be accountable for—all development activities in key technical areas such as CMC, pre-clinical safety and ADME, clinical development, regulatory affairs and project management in accordance with the early development plan.

Manage the individual projects to optimize resources and maximize the probability of success and the probability of timely completion

Proactively identify risks, assess their magnitude, and propose plans/strategies to mitigate them.

For major decision points, analyze data with the project team, put into strategic perspective, and propose recommended plan of action to management.

Between major decision points, analyze any new information and foresee its impact on project strategy and probability of success; recommend to management necessary change in strategy/objectives.

Ensure high quality and content of all project / program documentation. Work effectively either independently or within project teams to multi-task and work

under tight deadlines. Ensure appropriate internal/external communication about the projects and program in

accordance with corporate policy. Report directly to the Chief Development Officer and align with Lpath vision and R&D

strategy. Qualifications:

B.S. degree or higher in Biological or Physical Sciences. 5+ years' experience, preferably 10+,in the pharmaceutical industry in managerial

positions. Previous experience in GMP pharmaceutical development of biologics in the area of CMC

operations would be strongly desirable. Enthusiasm, willingness to learn, strong work ethic, broad scientific interests and

attention to detail. Demonstrated ability to work in a small-company team environment and excellent

oral/written communication skills. *********************************************************************** Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com Interested parties should contact/send resume to margaret@jgbbiopharma.com. No Work Visa sponsorship is available for this position. Manager, QA /QC – Full Time Position (San Francisco Bay Area) To view job description and other current positions please visit http://jgbbiopharma.com/jobs/. DESCRIPTION: • Oversee the development, implementation and maintenance of quality assurance and quality

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control systems and activities • Oversight and leadership of the QA/QC staff in the raw material lab, finished goods lab as well as to ensure proper control of the QA activities and GMP practices • Provide leadership and direction to the QA/QC team, to oversee and manage assigned staff including hiring, firing, work assignment, performance management, training and professional development. • Manage, evaluate and develop quality systems and processes for the inspection, testing and evaluation of company products. • Ensure processes and work standards are being followed by staff to ensure company products are precise accurate and reliable. • Develop budget and monitor expenditures for the department. • Assure finished products conform to government and company standards and satisfy GMP regulations. • Support customer and regulatory audits EXPERIENCE AND QUALIFICATIONS: • Proficient in Microsoft Word, Excel, and PowerPoint • Strong communication skills • Well organized and able to multi-task http://www.jgbbiopharma.com/jobs-category/quality-jobs ************8**************************************************************

Jobs That Crossed My Desk Through August 18, 2013-08-21 ************************************************************************ Apply on company website Director of Product Marketing IMS Health- San Francisco Bay Area Job Description At IMS Health, we tap the very best people, and then give them meaningful work to do. We don’t simply think about careers, we think about contributions. Those who choose to work with us are joining a recognized global leader — a company uniquely positioned to help clients make the most of market opportunities and respond to challenges that affect global healthcare. We’re committed to blending industry expertise and advanced technology to deliver the most accurate perspectives and in-depth analytics on healthcare dynamics. The key to our success is our people, whose experience, talent, commitment and diversity set the standard for the health information industry. Total Rewards We invest in people through a range of initiatives in compensation, benefits, and learning and development, and we strive to create an environment where our employees are challenged, empowered and can flourish. About Clinical Trial Optimization Solutions: IMS Health Clinical Trial Optimization Solutions (CTOS) is the leading provider of Trial Optimization Software Solutions to the Pharmaceutical and Biotechnology Industry and is entering a hyper-growth stage. Our flagship products, StudyOptimizer™, the industry’s first enrollment optimization solution for clinical trials, and GrantPlan™, the industry’s leading cost benchmarking and online negotiation tool, provide a solid platform for expansion of our product set. An integrated suite of process automation, predictive analytics, scenario modeling, enterprise data integration and visualization capabilities, our product set significantly reduces clinical trial costs and improves clinical operational efficiencies and effectiveness. Role Summary: The Director of Product Marketing will be responsible for developing, delivering, and driving the company’s product marketing strategy, positioning and messaging for our solutions. This means identifying robust market opportunities, defining key market differentiators, identifying

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market requirements and driving those back into the product teams, developing optimal positioning and messaging and guiding commercialization through the product launch process and the appropriate mix of outbound channels. This includes supporting the development and implementation of marketing initiatives, product collateral (both technical and promotional), selling aids, demonstrations and presentations. The scope of this position includes directly supporting the field organization by participating in qualified customer and prospect meetings to optimally position IMS CTOS product portfolio with the account. In addition, the Director of Product Marketing will partner with the CTOS product management team in securing innovative product and market requirements and driving product/market research into the product development process. For the experienced product marketing professional that has a successful track record of building, launching and growing software, business intelligence or clinical management solutions into the Life Sciences industry, this is a significant career opportunity. Responsibilities:

Develop and execute comprehensive product marketing strategies that: o Yield commercially successful solutions with significant growth and revenue

impact o Drive awareness of and usage of CTOS solutions

Define and manage the overall product marketing strategy and positioning for CTOS products; Serve as a product expert in dealings with thought leaders, analysts and press

Influence the product solution strategy and roadmap by capturing, analyzing and documenting market requirements, performing product line business and profitability analysis, sales win/loss analysis, evaluating product pricing

Develop a deep understanding of customer and market needs and behavior through primary and secondary research, market trends and competitive analysis and positioning

Develop and implement marketing initiatives, product collateral (both technical and promotional), selling aids, demonstrations, websites, presentations, whitepapers, articles, customer success story programs and webinars, newsletters and surveys, trade shows and company-sponsors seminars, customer advisory board and user group, etc

Work across the organization to drive sales, marketing, and partner strategies required for business and product launch success

Travel expectations – 25% Desired Skills & Experience Critical skills:

Strong creativity and innovation in positioning, messaging, differentiation, and go-to-market plans

World-class content creation Outstanding written and oral communication skills Strong organizational and analytical skills Team player Self starter who is comfortable working in a fast paced software environment

Requirements: Minimum 7 years experience in enterprise software product marketing Life Science, R&D, clinical background and knowledge of clinical trial sponsor and CRO

segments of the market strongly preferred Successful track record of developing and commercializing new software applications

with significant revenue and growth in the Life Science industry Proven track record in developing and implementing product marketing and strategic

business plans for solutions that have positive market and business impact Experience in documenting market requirements and driving requirements through

software development process

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Focus on business intelligence applications, predictive analytics, data integration solutions and web-services strongly preferred

Proven ability to manage multiple projects, set priorities and meet deadlines Experience in fast-paced environments with overlapping projects/deliverables

Education/Training: Bachelor’s degree required; Masters or MBA degree a plus

Company Description IMS Health is a leading provider of information, services and technology for the healthcare industry around the world. The company draws on its global technology infrastructure and unique combination of in-depth, sophisticated analytics, on-shore and off-shore commercial services, and consulting platforms to help clients better understand the performance and value of medicines. With a presence in 100+ countries and more than 55 years of industry experience, IMS serves leading decision makers in healthcare, including pharmaceutical manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community. IMS Health was founded in 1954 by Bill Frohlich and David Dubow. Ari Bousbib is IMS Health’s Chairman and Chief Executive Officer. Bousbib came to the company in August 2010 from United Technologies Corporation. IMS provides solutions in Healthcare Analytics and Services, Healthcare Measurement and Consulting. Additional information is available at http://www.imshealth.com. Additional Information Posted:July 25, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing, Product Management, Other Industries:Market Research, Pharmaceuticals, Information Technology and Services Job ID:6583859 ************************************************************************* Apply on company website MANAGER, MARKET INSIGHTS AND COMPETITIVE INTELLIGENCE Abbott- Oakland, US-CA (San Francisco Bay Area) Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. PRIMARY FUNCTION: This position is tasked with providing Primary and/ or Secondary marketing research and analytics support to the marketing and sales organizations within the Diabetes Care division. This person will provide direction and input to marketing, sales and forecasting related activities. Ability to understand the business needs and to develop and communicate information around these needs will drive success within this position. Reports directly to the Market Research Manager or Director. MAJOR RESPONSIBILITIES: Partners with Marketing and commercial leadership to identify research and analysis needs. Design appropriate research and analysis plans based on understanding of available research and analytical techniques Strong organization skills needed to manage research supplier(s) on cost, timing, appropriateness of research methodology, and actionability of conclusions

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Analyze and synthesize learnings from research and analysis , drawing conclusions that provide recommendations to business teams Utilizes knowledge of standard research and analytic methods to distill information into clear, concise communication oIndependently seeks and leverages market research and analysis peers and leaders, business partners and external vendors to ensure strong analysis and sound recommendations Exhibits strong analytic abilities in breaking down issues and developing solutions Translates results into clear, concise presentations and written reports, enabling brand and innovation team to quickly make marketing decisions Analyzes categories on a macro level utilizing multiple information sources (primary, secondary data and syndicated studies) to provide actionable consumer and business insights oUnderstands the market place, competitor dynamics and provides expertise on data interpretation for the marketing and sales organizations Partners with marketing managers, forecasting and finance in the planning process Displays a positive, solutionbased approach to all research issues and ability to work in teams. Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation. ACCOUNTABILTY / SCOPE / BUDGET: Primary support for providing market and customer information to the marketing, sales and forecasting organization Champions primary and / or secondary market research information within the Diabetes Care division Understands the market place and competitor dynamics and provides expertise on data interpretation for the marketing and sales organizations Partners with marketing managers, forecasting and finance in the planning process and provides a robust understanding of customers, competitors and consumers Desired Skills & Experience Bachelor's degree required. Master's degree preferred. Candidate must have a minimum of 5 years working experience in the market research and analytics field in industries such as Healthcare, Consumer Packaged Goods, Medical Devices or Pharmaceuticals or similar industries. Experience with secondary data analytics is preferred. Expert level Excel skills (create, amend, manipulate spreadsheets) required. Additional Information Posted:July 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Biotechnology, Market Research, Marketing and Advertising

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Compensation:0 Employer Job ID:13000005MT Job ID:6513695 ************************************************************************ Apply on company website Product Director, U.S. Oncotype DX Marketing Genomic Health, Inc.- Redwood City, CA (San Francisco Bay Area) Job Description Genomic Health is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com and www.mybreastcancertreatment.org POSITION SUMMARY: The Oncotype DX U.S. market Product Director is responsible for leading the cross-functional Breast Cancer product marketing efforts, Commercial Team and the overall commercialization of the Oncotype DX Breast Cancer Assay. The Product Director will also prepare new product assessments for the breast cancer franchise and will be responsible for launch plans for product extensions taken to U.S. market. The Product Director will also manage, coach and develop a team of Product Managers who are responsible for executing key components of the Brand Plan. This person will also be the lead for managing Advertising Agency projects for this product and geography. This comprehensive commercial responsibility will require a clear and directive style that is able to engage a broad set of teams to work cohesively and efficiently in a fast paced setting. Success in this position will require, broad strategic thinking, strong clinical knowledge, attention to detail and the ability to carry out multiple tasks in parallel in a dynamic and demanding cross functional team environment. Competitive candidates will possess significant, relevant marketing experience in the field of breast cancer, with a demonstrated ability to master complex scientific material and demonstrated ability to work with US thought leaders and other physicians. Competitive candidates will require strong presentation skills as they will be presenting to diverse audiences, including the field sales force, executive team, and medical teams, as well as potentially external audiences.

Develop a comprehensive Brand Plan for the Oncotype DX Breast Cancer Assay as well as product extensions, including branding/positioning/messaging/promotional and competitive strategies and supportive clinical development/medical affairs activities.

Establish a clear and aligned communication plan that leverages the publications and timing to align for subsequent materials and direction for field sales force.

Develop promotional tools including brochures, advertisements, and online content to convey messages and support awareness, education, and in doing so optimize the Channel Strategy for the Oncotype DX Breast Cancer Assay.

Ensure comprehensive training of the Sales force on key data, key messages, positioning, competitive strategies/positioning and all promotional tools and programs.

Analyze current market research in order to drive plans and coordinate all future market research, working closely with Market Research Analyst.

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Prepare short-term and long range sales forecasts for Management Review. Accountable for breast franchise deliverables for corporate planning (to include

Integrated Strategic Planning, Brand Planning, Long Range Planning and Operating Planning processes).

Manage marketing budget for breast franchise. Work closely with field sales and managed care teams to develop and train on

positioning and messaging for rapid adoption and customer education. Present a variety of material in front of diverse audiences, from All Company Meetings

to Field Sales Meetings, Trade Shows, Executive Meetings, board meetings, and other relevant audiences. The ability to inform and inspire is critical.

Exhibits strong people management and leadership skills, coaching, inspiring and mentoring direct reports within the team and across the Commercial organization.

Develop national breast cancer thought-leader advocates & coordinate participation in advisory boards and speaker development programs.

Work with the Corporate Communications & Advocacy team to develop consistent messages, and innovative digital/social media programs for Media and Patient audiences.

Master complex scientific information at a high level in order to analyze clinical studies by Genomic Health and other parties in the field of genomics and present this analysis to diverse audiences.

Maintain professional, engaging and patient focused communications with all internal and external audiences. We are an organization that must be firmly committed to premium customer service.

Maintain confidentiality as it pertains to sensitive scientific data, HIPAA protected information, SEC-protected filings and other designated topics, at all times.

Oncology experience required with strong preference for candidates who have worked directly with key opinion leaders in breast cancer in the USA.

Experience in the commercialization of oncology diagnostics would be an advantage. Strong leadership skills are required. Relevant experience in a tightly-controlled, regulatory environment and with managed

care. Proven analytic skills with scientific papers and market intelligence. Strategic thinker with potential for advancement as the Company grows. Willingness to travel extensively in the USA, as needed. Computer skills: word processing, spreadsheets, databases, familiarity and use of

Internet/World Wide Web, presentation development skills à MS Office expertise must be at a very high level.

Writing skills: memos, letters, data analyses, with proper grammar and spelling. The competitive candidate will be a great writer and tireless reviewer with a sharp eye for language.

Demonstrated ability to manage multiple, simultaneous, complex tasks and to meet deadlines.

A positive mental attitude to daily tasks; a net contributor to overall morale. A demonstrated willingness to exercise initiative in cases where decisions need to be

made and supervisors are not available to consult, coupled with the tact and judgment to do so appropriately.

Demonstrated communication skills, presentation skills, verbal, tact, composure and confidentiality in order to coordinate complex personnel issues, schedules, travel, and logistical projects & programs in and outside of GHI.

BA or BS required. Advanced degree strongly preferred (MS, MBA, PhD, MD, RN, PharmD) or equivalent experience

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Minimum of 10 years of progressively responsible management experience in marketing or new product planning with a strong track record of success and accessible references. Field sales experience in oncology is a significant benefit.

Able to integrate and apply feedback in a professional manner. Able to prioritize and drive to results with a high emphasis on quality. Ability to build collaborative, effective cross-functional partnerships and influence across

the organization. Demonstrated ability to work with executives in Research, Development, Commercial

and Medical Affairs. Additional Information Posted:July 22, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Biotechnology Employer Job ID:3103 Job ID:6509720 Veteran Commitment

*********************************************************************** Apply on company website Senior Medical Director, Clinical Science BioMarin - San Francisco Bay Area Job Description BioMarin Pharmaceutical seeks a medically-trained clinical scientist with expertise in clinical research and drug development to join a multidisciplinary team involved in development of novel therapeutics for rare/orphan diseases. The candidate should be proficient in clinical study design, and execution and analysis of results. Experience interacting with clinical investigators, FDA and other regulatory authorities is highly desired. RESPONSIBILITIES 1. Hands-on participation in the clinical trial development process - conceive and execute clinical strategy and provide clinical expertise in all phases of development from pre-IND to Phase 4 2. Lead preparation of clinical sections of all relevant regulatory filings (BLA, EU Marketing application, IND, study reports, NDA, etc) 3. Participate in management of studies and serve as expert on clinical and medical issues to internal colleagues and study site staff 4. Take leadership role in review and analysis of study data and writing of study reports (CSRs) 5. Lead preparation of responses to regulatory agency queries (RTQ) and participate in FDA pre-marketing authorization meetings, EMA Scientific Advice meetings and other regulatory agency meetings 6. Attend and provide clinical/scientific support for investigator and consultant meetings 7. Assist in writing and preparing publications, abstracts and presentations 8. Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan 9. Serve as medical/scientific resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources 10. Interact in collaborations with strategic partners

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11. Represent the company at scientific, commercial and financial community meetings and presentations 12. Serve as the Medical Monitor and Leader for clinical trials 13. Provide input/review study start up documentation, e.g. source data verification plans based on protocol specifications, CRF design 14. Contribute to planning and compliance with inspection readiness 15. Support business development activities, including due diligence activities 16. Interact with research/discovery to review and identify lead candidate molecules for Clinical Development To apply: http://tinyurl.com/mym7ex6 Desired Skills & Experience EDUCATION MD or MD/PhD Post-graduate training/experience essential (i.e., U.S. internship/residency, (board-eligible as a minimum), or fellowship,) EXPERIENCE 1. For appointment at the Senior Medical Director level a minimum of 7 years experience in the pharmaceutical/Biotech industry is required 2. For appointment at the Medical Director level; 5+ years experience in clinical functions in pharmaceutical or biotech industries. 4. Knowledgeable and current in GCP guidelines in US and Europe 5. Be well connected within the medical and scientific community and have a proven successful track record in management of clinical trials 6. Outstanding leadership, team, presentation, written and oral skills required 7. Collaborative and flexible in personal interactions at all levels of the company 8. Ability to work proactively and effectively, with exceptional creative problem solving skills 9. Works well with project teams and the respective functions, in particular Regulatory Affairs, Clinical Operations, Biometrics, but also Project Management, Research, Clinical Pharmacology and Commercial. 10. A strong interest in rare diseases that frequently requires creative thinking with regards to study design, endpoint selection or data analysis. 11. Experience in one or the following therapeutic areas would be considered advantageous: endocrinology, neurology, pediatrics, allergy/immunology To apply: http://tinyurl.com/mym7ex6 Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers.

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Additional Information Posted:August 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Biotechnology, Pharmaceuticals Employer Job ID:13-0197 Job ID:6679545 ******************************************************************* Apply on company website Senior Product Manager / Product Manager, Nephrology Marketing Questcor Pharmaceuticals, Inc. - US-CA-Hayward (San Francisco Bay Area) Job Description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking a Senior Product Manager / Product Manager, Nephrology Marketing. The incumbent is responsible for developing and executing efforts for in-line product marketing under the direction and leadership of senior marketing management. This position will work with field sales, vendors and Acthar team members to develop and execute results-oriented, highly effective marketing initiatives for our key promoted brand, H.P. Acthar Gel. Responsibilities:

Work cross-functionally with commercial team members (marketing, sales, analytics, reimbursement, medical affairs, etc.) to develop and execute programs and materials that support achievement of Nephrology business goals;

Manage ad agency and other vendors in development of materials and tactics; Manage national conference planning and execution; Develop strong relationships with physician leaders and contribute to advisory board

planning; Develop and implement best-in-class speaker programs to support field sales efforts; Effectively interact with sales force and handle field requests; Provide input to development and implementation of annual product marketing plans; Manage allotted budget at or below plan while maximizing effectiveness of resources

and funds; Overnight travel as required (~25-30%).

Qualifications:

Minimum of 4 years of bio/pharmaceutical brand management including experience working on projects that involved developing promotional materials and working with opinion leaders (required);

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Two years successful experience in pharmaceutical sales (preferred); Strong ability to manage multiple projects simultaneously and work independently when

appropriate; Excellent leadership, teamwork, communication and relationship-building skills; Strong project management and communications skills; Bachelor’s degree (required).

Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits. Questcor is an Equal Opportunity Employer. Additional Information Posted:July 29, 2013 Type:Full-time Experience:Not Applicable Functions:Advertising, Marketing, Product Management Industries:Biotechnology, Hospital & Health Care, Pharmaceuticals Employer Job ID:1265 Job ID:5945978 ***************************************************************** Apply on company website Senior Product Manager, Dermatomyositis/Polymyositis (DM/PM), Rheumatology Marketing Questcor Pharmaceuticals, Inc.- US-CA-Hayward (San Francisco Bay Area) Job Description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking a Senior Product Manager, Dermatomyositis/Polymyositis (DM/PM), Rheumatology Marketing. The incumbent is responsible for developing and executing efforts for in-line product marketing under the direction and leadership of senior marketing management. This position will work with field sales, vendors and Acthar team members to develop and execute results-oriented, highly effective marketing initiatives for our key promoted brand, H.P. Acthar Gel. The successful candidate will be responsible for developing and executing in-line product marketing efforts for Questcor’s key promoted product ACTHAR in DM/PM under the direction and leadership of the Director, DM/PM Rheumatology Marketing. The candidate will work with field sales, vendors and ACTHAR team members to develop and execute highly effective, results-driven marketing initiatives to maximize product opportunities and revenues in DM/PM.

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This position is located at Questcor’s corporate office in Hayward, CA. Responsibilities:

Work cross-functionally with commercial team members (marketing, sales, analytics, reimbursement, medical affairs, etc.) to develop and execute programs and materials that support achievement of business goals.

Manage ad agency and other vendors in development of materials and tactics. Develop strong relationships with key opinion and physician advisory board members. Develop and implement best-in-class speaker programs to support field sales efforts. Effectively interact with sales force and handle Rheumatology field requests. Contribute to the development and implementation of annual product marketing plans. Manage allotted budget at or below plan while maximizing effectiveness of resources

and funds. Qualifications:

Bachelor degree required, MBA degree preferred. Minimum of 3 years of bio/pharmaceutical brand management responsibility including

experience working on projects that involved developing promotional materials and working with Key Opinion Leaders.

Minimum of 2 years successful experience in pharmaceutical sales (preferred) Strong ability to manage multiple projects simultaneously and work independently when

appropriate. Excellent leadership, teamwork, communication and relationship-building skills. Strong project management and communications skills. Rheumatology Experience Preferred. Overnight travel as required (25-30%).

Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. Additional Information Posted:July 31, 2013 Type:Full-time Experience:Not Applicable Functions:Advertising, Marketing, Product Management Industries:Biotechnology, Hospital & Health Care, Pharmaceuticals Employer Job ID:1460 Job ID:6642919 ***************************************************************** Apply on company website Acthar Specialist, Rheumatology Questcor Pharmaceuticals, Inc.- US-CA-San Francisco (San Francisco Bay Area) Job Description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-

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resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking an Acthar Specialist, Rheumatology. Responsibilities: The successful candidate will be able to show documented success as a top producer. They will effectively manage their territory as a results-oriented sales person, business partner and consultant. They will develop strategically targeted, accounts and specific business plans that reflect an in-depth understanding of local, regional and national market forces impacting product sales. The incumbent will skillfully deal with the concepts and complexities associated with the products and adjunctive therapies and must demonstrate an in-depth understanding of the clinical data. Qualifications:

Bachelor degree and/or 3-5 years pharmaceutical sales experience; Rheumatology experience required; Local travel; some overnight required (10-20%).

Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. Additional Information Posted:August 14, 2013 Type:Full-time Experience:Not Applicable Functions:Sales, Business Development, Marketing Industries:Biotechnology, Hospital & Health Care, Pharmaceuticals Employer Job ID:1326 Job ID:6492867 ***************************************************************** Apply on company website Acthar Specialist, Rheumatology Questcor Pharmaceuticals, Inc. - US-AL-Mobile (Mobile, Alabama Area) Job Description Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options. The Company booked $548 million in net sales during the 12 months ended March 31, 2013,

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which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B. We are currently seeking an Acthar Specialist, Rheumatology. Responsibilities: The successful candidate will be able to show documented success as a top producer. They will effectively manage their territory as a results-oriented sales person, business partner and consultant. They will develop strategically targeted, accounts and specific business plans that reflect an in-depth understanding of local, regional and national market forces impacting product sales. The incumbent will skillfully deal with the concepts and complexities associated with the products and adjunctive therapies and must demonstrate an in-depth understanding of the clinical data. Qualifications:

Bachelor degree and/or 3-5 years pharmaceutical sales experience; Rheumatology experience required; Local travel; some overnight required (10-20%).

Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and stock options. For more information, you may view our website at http://www.questcor.com/careers/company-benefits . Questcor is an Equal Opportunity Employer. Additional Information Posted:July 26, 2013 Type:Full-time Experience:Not Applicable Functions:Sales, Business Development, Marketing Industries:Biotechnology, Hospital & Health Care, Pharmaceuticals Employer Job ID:1493 Job ID:6592302 ********************************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=6635367&trk=rj_em&fromEmail=&ut=1WC8hb6A3A8BU1 Clinical Science Manager (Pacific Northwest) Synageva BioPharma Corp.- San Francisco Bay Area Job Description JOB TITLE Clinical Science Manager DATE AVAILABLE Immediately LOCATION United States (Pacific Northwest) Responsibilities Lead and manage the development and execution of market development objectives, strategies, tactics, and action plans to ensure the short- and long-term growth and success of Synageva in the Pacific Northwest.

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Ensure achievement of the following three key imperatives and performance measures: o Increase disease awareness with key audiences. o Identify patients and assist in bringing them on to therapy, initially in clinical

trials prior to marketing authorization. o Establish a key opinion leader (KOL) network.

Establish and coordinate a health care partnership with the patient at the center surrounded by relevant stakeholders such as:

o Patient families. o Patient advocacy associations. o KOLs. o Treating physicians and other caregivers.

Lead by example to ensure effective and cooperative cross-functional physician and patient outreach efforts.

Demonstrate and instill a burning sense of urgency, humility, and passion to find and treat patients.

Communicate effectively with all levels of Synageva staff and management. Participate in strategy development, assessing trade-offs between initiatives and

priorities, followed by implementing final decisions Desired Skills & Experience

A bachelor’s degree or credentialing in a relevant discipline. A graduate degree is advantageous but not essential. A good knowledge of US markets and medical communities. A minimum of five years commercial experience interacting with medical doctors. Relevant experience in the rare diseases space encompassing patient identification and

treatment; interactions with patient advocacy associations; establishment of KOL networks; and achievement of market access is highly desirable but not essential.

Strong oral and written communication skills Demonstrable ability to collaboratively work as a team player in a dynamic and fast

moving organization. The following personal characteristics:

o A bias towards action combined with high ethical standards. o A self-starter combined with a high energy level. o Self-confidence combined with humility in approach. o Compassion and passion for patients. o An ability and willingness to take controlled risks. o A willingness and desire to be a team player

States included in the Pacific Northwest Territory are: Northern California, Washington, Oregon, Northern Nevada, Idaho, Wyoming and Montana.

Strong preference for person to have home base in San Francisco/ Bay Area. Ability to travel: 50-60% of the time.

Company Description Synageva BioPharma is a biopharmaceutical company with headquarters, research and development facilities in Lexington, MA. Synageva was formed to focus on novel orphan treatments for rare diseases. Our lead program, sebelipase alfa, is a recombinant human LAL (rhLAL), an enzyme replacement therapy for LAL Deficiency. Sebelipase alfa is currently in global clinical development and has been granted orphan designations by the US Food and Drug Administration ("FDA"), the European Medicines Agency, and the Japanese Ministry of Health, Labour and Welfare. Additionally, sebelipase alfa received fast track designation by the FDA and Breakthrough Therapy designation by the FDA for early onset LAL Deficiency. LAL Deficiency is a rare, serious and devastating lysosomal storage disorder (LSD) that results in significant morbidity and mortality. Synageva has four additional orphan products in development. To ensure that these therapeutic candidates reach patients in need, Synageva

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has recruited a team with a proven record of discovery, development and commercial experience within rare diseases. Synageva BioPharma Corp. Additional Information Posted:July 30, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science Industries:Biotechnology Job ID:6635367 **************************************************************** Apply on company website Clinical Science Specialist Genentech - US - California,South San Francisco (San Francisco Bay Area) Job Description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position Job Description (gRED ECD Onc Clinical Science Specialist [E4a]) Genentech is seeking a Clinical Science Specialist (CSS) with clinical and drug development experience in oncology to join the Genentech Research and Early Clinical Development (gRED) Oncology ECD organization and support Clinical Science deliverables for clinical trials and programs associated with the exploratory clinical development of novel anti-cancer agents within the Genentech portfolio. These programs span first-in-human Phase I studies through proof-of-concept Phase II studies in a variety of malignant disorders, and may involve collaborations with other Clinical Development teams at Genentech, corporate development partners, and external scientific/academic/clinical organizations. The optimal candidate will have the desire to proactively participate within a multi-disciplinary team of internal clinical and commercial colleagues and have the ability to interact with external experts and investigators. Job Duties and Responsibilities: Scientific Writing

Draft Strategic Context Documents (SCD), Clinical Protocols, and Investigator Brochures, and coordinate the successful completion of documents with medical editing.

Conduct literature searches, draft abstracts, draft safety narratives, draft background sections of clinical documents, and ensure that standardized disease/molecule protocol language is incorporated (e.g., eligibility, dose-modification criteria, risk language, key scientific statements). Track items for inclusion in protocols and ICF amendments and work with Medical Editing to ensure the completion of the protocol and any subsequent amendments.

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Functional Activities

Serve as a Clinical Science representative on cross-functional teams as assigned (i.e., Protocol Execution Team, Safety Sub-Team, Biomarker Sub-Team, cross-functional initiatives).

Identify and implement processes to share clinical information across teams/molecules/indications.

Develop study-specific listings with data management representatives and conduct frequent clinical data listing reviews.

Working closely with the gRED medical monitor, serve as primary point of contact for, and triage, clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions. .

Partner with Data Management for CRF design, instructions for unique CRFs, and data quality plan.

In conjunction with a Medical Director, create and or review clinical slides for internal and external meetings (i.e. Investigator meetings, PSSV and SIVs, Study Coordinator and CRA training, Advisory Boards, scientific meetings). Develop and QC data tables with biostatisticians to support these activities.

Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).

In conjunction with Biostats and Medical Director review appropriate analysis and reporting documents (i.e. clinical study report, analysis plan, etc.).

As assigned, participate in development of the long-range strategic plans for the assigned program(s).

As assigned, participate in Clinical Science assessment of in-licensing opportunities. As assigned, mentor and/or train new Clinical Science Specialists

Who You Are Experience

Candidates should have an advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.).

6 or more years of industry/related experience (a focus on cancer cell biology or drug development is preferred).

4 or more years of clinical trial experience in industry 2 or more years of experience in, and appropriate therapeutic knowledge of, oncology Extensive knowledge of clinical research & successfully worked across Phase I – II drug

development projects Experience working on cross-functional teams Experience authoring a full clinical trial protocol (Ph I or II) Broad experience in the principles and techniques of data analysis, interpretation and

clinical relevance Comprehensive understanding of product and safety profiles Well-versed in medical aspects of GCP, ICH, FDA, EMEA, NICE and other relevant

guidelines Preferred: Experience publishing clinical trial results in refereed journals

The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an Equal Opportunity Employer. Additional Information Posted:July 29, 2013 Type:Full-time Experience:Associate Functions:Research, Science

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Industries:Biotechnology, Pharmaceuticals Employer Job ID:00412468 Job ID:6283799 ********************************************************************** If you are qualified and interested please contact me privately at dave@alpinesearch.net Dave Murphy The Alpine Group www.alpinesearch.net Sr. Marketing Manager - Molecular Diagnostics, Bay Area To view a brief video about this opportunity please click here: http://youtu.be/DSQ-H_2BiJg A midsize Biotech client of mine has asked me to help them fill a new Sr Marketing Manager role in the infectious disease segment of the Molecular Dx market. This will be a mixed role of upstream and downstream marketing on a global basis, in a company that has grown revenue 20% per year for the fast four years. The level is a step up from Sr PM, but does not yet have any direct reports. Qualifications: - 5+ years of marketing experience in the clinical diagnostics industry, or a combination of diagnostics and pharmaceuticals - Specific marketing experience in Infectious Disease or Virology - Account Management, Sales, or Sales Support experience *********************************************************************** Please send your resume to: amanda.rodriguez@iglobalrecruit.com Urgent: Assistant Director Trainee, HLA (Greater Los Angeles Area) - Fulltime position Position Summary and Key Responsibilities The Assistant Director Trainee will be responsible for the clinical research and development in transplant immunology and to support the clinical laboratory services under the direction of the laboratory director so that high quality and state-of-the-art laboratory testing and services are achieved. Responsibilities will include:Clinical Research and Development: Create projects, design experiments, write protocols for IRB approval and manuscripts for publication, and validate new clinical testing techniques as well as Clinical Laboratory Business: Provide advice to transplant physicians, unrelated donor search coordinators, and other clinicians; review the results of clinical testing in the absence of the lab director and supervisor; investigate result discrepancies between our reports and NMDP records. Desired Skills & Experience • Minimum Education: Doctoral Degree • Req. Certification/Licensure: Certificate from related professional societies and CA licensure __________________________________________________________________ Urgent: Director, Clinical Molecular Diagnostic Laboratory (Greater Los Angeles Area) - fulltime Desired Skills & Experience Minimum Education: M.D. and/or Ph.D. required Ideally Ph.D should be a Clinical Molecular Geneticist Must be boarded by the American Board of Medical Genetics in clinical genetics and hold a State of California Clinical Molecular Biologist Director license.

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Prior fellowship in Molecular Genetics or Pathology preferred Minimum Experience: 3 years experience as a laboratory Director or Co-Director. Skills Required for Consideration: Excellent interpersonal and management skills, including proven management, presentation, negotiation, team facilitation, and written communication. Thorough knowledge of Human Genome Variation Society (HGVS) Nomenclature guidelines and excellent detail-oriented work habits. Thorough knowledge of State, CAP, JCAHO, and institutional policies and procedures for directing a clinical laboratory. Possess knowledge of institutional and regulatory policies, technical procedures, project and time management aspects of new test development, and institutional (cancer center) best practices. Must have ability to provide objective input on operational issues, be able to lead large, complex, multidisciplinary projects and have an understanding of a broad set of problem-solving methods. Must be able to interact with a variety of personnel at various levels within and outside the organization. Must be able to evaluate and troubleshoot next generation sequencing technologies and perform appropriate computational and statistical analyses of the data, as well as meet regulatory requirements necessary for this testing. Please send your CV to amanda.rodriguez@iglobalrecruit.com *************************************************************** Apply on company website Technical Business Development Director – Biologics Ajinomoto Althea, Inc. - Greater San Diego Area Job Description Be part of a growing and innovative organization! Ajinomoto Althea has an opportunity for a Technical Business Development Director – Biologics. As part of the field sales team, this position will be responsible to drive the sales goals and objectives globally for the Biologic Business Unit. This position will be the liaison between the field business development team and operations to facilitate all biologic opportunities within the organization. This position will work with Marketing to drive lead generation, opportunity creation, promotional activity and trade shows to create more brand recognition Responsibilities:

Works along with VP of Sales to establish the overall sales strategy for the Biologic Manufacturing Group.

Works with the Business Development team, to develop relationships with clients to understand key applications and generate customer driven product requirements.

Achieve or exceed sales goals and objectives by actively selling to clients in the field. Frequent travel with the BD team will be required to visit customers in person. Develop a working knowledge of current and potential activities that may affect revenues.

Develop proposals on prospective opportunities for BD team. Working with Marketing, create a Biologic marketing plan that includes targeted lead

generation, promotional activities, industry events, poster and speaking presentations, and web presence.

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Presents sales presentations for internal and external customers. Assists the VP of Sales with product trending and industry/market trending and may

routinely gather account and client information. Interfaces with quality systems, manufacturing and quality management personnel on

issues related to products in the field. Utilizes the CRM database to input and provide information that will increase

effectiveness and aid sales. Stays current on developments within the industry. Attends tradeshows. Utilizes technical expertise and expanding customer relationships to identify areas of

improvement and new product opportunities. Responsible for exhibiting professional behavior with both internal and external

business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Desired Skills & Experience Requirements:

Ph.D. preferred or an advanced degree in a life sciences field. Three plus (3+) years’ direct, relevant experience in sales/business development. It is

highly preferred that the candidate have up to 10 years of experience either in business development or manufacturing

Previous work experience with a Contract Manufacturing Organization or with the development, manufacturing or analytical testing of sterile biotechnology products is required.

Minimum of ten (10) years relevant experience in laboratory/manufacturing experience, including process development, optimization, scale-up, cGMP.

Analytical development experience preferred. Proven ability to build key customer relationships with the ability to educate and

demonstrate technical value propositions in order to promote the Althea difference and possess an outstanding drive for excellence and results.

High aptitude to learn technical and scientific information. Detail oriented with strong written and verbal communication skills. Must be familiar with Microsoft Office applications

Ajinomoto Althea, located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early- stage and commercial requirements. If you meet the requirements above and would like to apply for this position, please visit our website at www.atheatech.com and click on the ‘Careers’ section. Althea is an EOE dedicated to a diverse work force and Drug Free work environment. Qualified M/F/D/V candidates are encouraged to apply. Company Description Formerly Althea Technologies, Ajinomoto Althea is a San Diego-based biologics CDMO partner that provides clinical/commercial product development services, including production of microbial-derived recombinant proteins and plasmid DNA and cGMP filling in vials/syringes. Ajinomoto Althea also offers process development, analytical development, complex formulation, release testing, and stability testing services. Ajinomoto Althea also has an innovative and proven recombinant protein expression technology called Corynex™. Corynex™ can deliver simplified production with better results. Learn more at www.altheatech.com. Additional Information Posted:August 12, 2013 Type:Full-time Experience:Mid-Senior level

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Functions:Business Development Industries:Biotechnology Job ID:6807180 __________________________________________________________ VP, Biologics Manufacturing Ajinomoto Althea, Inc.- Greater San Diego Area Job Description Be part of a growing and innovative organization! Ajinomoto Althea has an opportunity for a senior leadership team member that will be responsible for providing company direction in the area of Biologics. This role will provide strategic vision and leadership to the department overseeing successful biologics campaigns, sales and growth. Responsibilities:

Responsible for overseeing the P&L of Biologics (operations, sales and compliance). Accountable for developing, building and executing Biologics business plan. Drives resources to address priorities, meet production schedules, maximize

productivity, reduce costs, and increase efficiencies through continuous improvement strategies.

Develops and monitors departmental budget, including setting and meeting targets. Responsible for developing and maintaining strong long term relationships with

customers. Stays abreast of developments within the field of biologics, biotechnology process

development, and manufacturing and changes in the relevant regulatory requirements. Ensures collaboration and commitment between Biologics and other departments

(Quality, Materials, Sales, Finance) in order to meet internal and external customer expectations.

Manages multi-functional teams by influencing, motivating and setting clear objectives. Develops and consistently meets production, quality, compliance, financial and EH&S

goals and objectives. Responsible for exhibiting professional behavior with both internal and external

business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Desired Skills & Experience Requirements:

Strong operational background with knowledge of bio CDMO industry Widely recognized in CDMO market and with bio pharmaceutical customers as a reliable

and strategic partner. Proven ability to create reliable long term relationships with customers. Documented track record of successfully engaging and securing new clients and

executing manufacturing programs in a multi-product facility. Experience with all phases of clinical trials and commercial manufacturing preferred. Proven understanding in the design and operation of fermentation/purification

processing, and cGMP manufacturing operation requirements. Minimum of twelve (12) years of experience in biopharmaceutical industry with strong

operation background. Minimum of six (6) years of progressive leadership experience. CMO business management experience strongly preferred. Must possess a broad knowledge of biopharmaceutical manufacturing and operations. Balance of strategic thinking and strong analytical skills with ability to execute. Advanced degree (Ph.D) strongly preferred, bachelor’s degree in a Life Sciences

discipline or equivalent required. Detail oriented and results driven with strong written, verbal communication and

presentation skills.

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Must be familiar with Microsoft Office applications. Ajinomoto Althea, located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early- stage and commercial requirements. If you meet the requirements above and would like to apply for this position, please visit our website at www.atheatech.com and click on the ‘Careers’ section. Althea is an EOE dedicated to a diverse work force and Drug Free work environment. Qualified M/F/D/V candidates are encouraged to apply. Company Description Formerly Althea Technologies, Ajinomoto Althea is a San Diego-based biologics CDMO partner that provides clinical/commercial product development services, including production of microbial-derived recombinant proteins and plasmid DNA and cGMP filling in vials/syringes. Ajinomoto Althea also offers process development, analytical development, complex formulation, release testing, and stability testing services. Ajinomoto Althea also has an innovative and proven recombinant protein expression technology called Corynex™. Corynex™ can deliver simplified production with better results. Learn more at www.altheatech.com. Additional Information Posted:August 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Manufacturing Industries:Biotechnology Job ID:6807149 ****************************************************************** To apply for this temporary assignment, please include your name and this position title in the subject line of your email, and send your resume to: careers@igenica.com. For further information about Igenica, please visit our website at www.igenica.com. Igenica, Inc. is a biopharmaceutical company focused on the creation of breakthrough antibody-based therapeutics to address the unmet medical needs of cancer patients. The company has developed innovative technology platforms for discovering novel tumor antigens and cancer antibodies and is supported by world-renowned scientific experts and advisors. Igenica has long term funding, and is currently expanding its research and development operations. Igenica is based in the San Francisco Bay Area. We are presently seeking to fill the following position:

Research Associate (In Vivo Biology) (Three Month Assignment)

There is an opening for a temporary position for a highly motivated in vivo biologist to support our core drug discovery activities for the development of novel cancer antibody therapeutics. The successful candidate will implement and conduct in vivo immunization studies in rodents for profiling the immunological effects of novel cancer targets.

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This position requires a BS/MS in Biology or equivalent discipline with several years of relevant experience. Excellent hands-on in vivo skills are mandatory. Proficiency with modes of animal dosing (IP, IV, SQ and ID) is required. Tissue sample analysis using standard molecular, cellular and biochemical techniques such as FACS and ELISA is desired. Cell culture experience is also desired. Candidates must be able to work independently and document, analyze, interpret and present results within a multidisciplinary team environment. Additionally, they should have demonstrated excellent communication, organizational and multi-tasking skills, be a team player, and have familiarity with basic methods of statistical analysis. ****************************************************************** Director Sales Compensation – CCP Required - 74473 http://www.linkedin.com/jobs?viewJob=&jobId=6623784&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=1Qh_JFSFdc7lU1 McKesson- San Francisco (San Francisco Bay Area) Job Description Director Sales Compensation – CCP Required Job ID 74473 San Francisco POSITION OVERVIEW Responsible for the development, implementation, analysis and maintenance of the company's sales compensation programs. Works with sales management to create and execute the strategic vision for the sales compensation programs. Calculate and pay incentives on a quarterly basis. Provide and communicate sales effectiveness metrics to senior management on a regular basis. RESPONSIBILITIES

Lead cross-functional sales compensation planning team. Model compensation incentives and earnings scenarios based on the company’s strategic business objectives and the financial forecast. Partner with business/functional areas to drive key strategic initiatives around sales incentive compensation and improve current process and procedures.

Administer, calculate and pay commissions on a quarterly basis. Provide direction, coaching and development of sales compensation analyst in his/her

various responsibilities in support of sales compensation function. Assess effectiveness of sales compensation plan incentives by analyzing plan results,

such as earnings vs. target plans, quota attainment distribution, pay to performance relationships, etc. and determine whether alternative incentives are needed to drive behavior in support of strategic objectives. Provide recommendations on total comp/mix based on market, internal equity, and business goals. Perform other ad hoc analysis and projects as needed.

Partner with Finance and Sales Effectiveness in the compilation of sales force performance metrics. Prepare presentations for senior management and manage the approval process for sales compensation plans.

Design and execute against annual sales award program for top performers in the organization.

Provide consultation to senior management regarding proposed SPIFFs/incentives and administer SPIFFs/incentives.

Modify sales plan documents as needed. Coordinate publication of the documents with the sales force. Advise Human Resources, Finance and the Commission administration group with respect to interpretation and administration of the sales compensation plan. Work with HR, Legal, and Compliance on key terms/conditions and final approvals. Maintain a working knowledge of federal and state legislation which may affect compensation policies.

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Desired Skills & Experience QUALIFICATIONS / MINIMUM REQUIREMENTS Education/Training: 4-year degree in HR, Business, or related field or equivalent experience Business Experience: 8+ years compensation experience including 3+ years managerial experience Specialized Knowledge/Skills

Excellent management, communication and analytical skills nowledge of state and federal laws pertaining to compensation Must have sales compensation experience Must be a strategic thinker as well tactical (actual calculations). Must be able to design and develop sales compensation programs that maximize the

ability across the organization Must be able to understand a very complex organization with multiple IC plans. CCP (Certified Compensation Professional) required CSCP (Certified Supply Chain Professional) desired

Company Description ABOUT McKESSON Making a difference starts with you. It can be as simple as helping a customer or as complex as creating lifesaving technology. When you work with McKesson, you initiate a chain of events that results in millions of people getting more from their healthcare. As the nation’s leading healthcare services company, we touch virtually every aspect of healthcare. We empower our customers by delivering vital supplies and solutions. And we empower all 32,000 of our employees through a collaborative environment that supports employee network groups and diversity councils. In our inclusive community, opportunity and responsibility grow. At McKesson, we believe we can empower healthcare. And it all starts with you. APPLY TODAY Please apply via this website, via our website at www.McKesson.com/careers or send your resume directly to wendi.mclane@mckesson.com. Additional Information Posted:August 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Hospital & Health Care Employer Job ID:Job ID 74473 Job ID:6623784 ********************************************************************* Posted by Connie Hampton http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=265520334&gid=4700652&trk=eml-anet_dig-b_nd-pst_ttle-cn&fromEmail=&ut=3PTLusMSkH7lU1 Searching for a Sr. Manager of Process Development and a Director of Process R&D (drug product) for a company in Emeryville, CA. We really need people who understand wurster fluid bed coating for extended release capsules. Know anyone? ********************************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=6840359&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=2t-Wlty4wy7lU1 Quality Manager National Staffing Consultants- Fremont, CA (San Francisco Bay Area) Job Description

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Quality Manager ~ Fremont CA Area ~ NEW & EXCITING POSITION! We are searching for a Quality Manager for our client just north of the Fremont, CA Area. This role requires a strong background in Quality Management Systems with a track record of success in quality improvements. Please note that relocation assistance is NOT being offered for this role. Brief Overview: The Quality Manager will be accountable for the development, implementation and maintenance of systems and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. This position is a hands-on role and would oversee three small sites. Desired Skills & Experience Requirements:

Bachelor's degree in a scientific discipline or related discipline. Master's degree in a scientific discipline or related discipline desired but not required.

6-8+ years of successful experience in a senior level Quality Manager capacity. Life science industry is preferred. Will consider industry experience in

Telecommunications or Electronics. Demonstrated experience working in a highly matrixed organization, preferably in a

manufacturing setting. Certifications preferred: American Society of Quality Certified Quality Manager (C.Q.M). Requires prior managerial experience. Knowledge of FDA practices and guidelines. Knowledge of pharma/biotech bulk and finished product manufacturing and analytical

testing requirements. Knowledge of analytical instrumentation and software, and medical devices. Knowledge of ISO 9001, ISO 13485, cGMP and QSR. Experience bringing a site to being 9001 certified is a plus!

Please note we have multiple roles open in this area that vary in scope. Contact us today to learn more. Email : tarabenoit@national-staff.com Company Description National Staffing Consultants is a National Search Firm Serving the Life Sciences Industry. “You have the best recruiters I’ve ever worked with.” At National Staffing Consultants, we hear this compliment time again from our clients and candidates. So what makes us different from other search firms? As a boutique executive recruiting firm, we focus on job recruitment for the Biotechnology, Medical Device, and Pharmaceutical industries in Greater Boston, MA, New England, and throughout the U.S. We bring PASSION, DEDICATION and COMMITTMENT to our work. We delive at nothing less than 100% and have 20 years of proven success. See for yourself what clients and candidates have to say about working with the recruitment team at National Staffing Consultants. Contact us today! http://www.national-staff.com/contact-us.html OR http://www.info@national-staff.com National Staffing ConsultantsAdditional Information Posted:August 14, 2013 Type:Full-time Experience:Mid-Senior level Functions:Quality Assurance Industries:Pharmaceuticals, Medical Devices, Biotechnology Compensation:Salary + Bonus Referral Bonus:Referral Bonus Yes

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Job ID:6840359 ********************************************************************* https://jobs.smartbrief.com/action/listing?listingid=F5F2C55B-59A7-4026-83B3-21D6464C0618&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Senior Regulatory Affairs Manager Actelion Pharmaceutical US, Inc Job Description JOB DETAILS The primary responsibility of the Regulatory Affairs Senior Manager is to provide regulatory expertise and guidance on Actelion advertising and promotion to ensure compliance with applicable regulations and guidance. This position is also responsible to champion the strategic development and tactical implementation of Risk Evaluation and Mitigation Strategies (REMS).

Provide regulatory expertise and advice regarding advertisement and promotion materials (e.g. marketing materials, education materials, institutional promotion, disease education, press releases, websites, speaker presentations).

Chair and represent Regulatory Affairs on the cross-functional Actelion Review Committee (ARC) for assigned product(s).

Build positive working relationship with FDA Office of Prescription Drug Promotion in support of Actelion advertising and promotion submissions and compliance.

Provide direction and supervision to assure quality and timely submission (including electronic submission) of advertising and promotion materials to OPDP in accordance with regulations to support business objectives.

Provide strategic direction and tactical implementation of Risk Evaluation and Mitigation Strategy (REMS) program for assigned product(s).

Facilitate and lead cross-functional teams during the development, implementation and life cycle maintenance of REMS program on assigned product(s).

Responsible for preparation of complex regulatory reports and submissions supporting REMS.

Apprise management of developments and issues relating to REMS program. Develop materials and train Specialty Pharmacy partners (SPs) for Actelion marketed

products to help assure adherence to REMS requirements. Document that current SPs are appropriately trained and have completed certification requirements.

Mobilize rapid response team in South San Francisco office as necessary to address any gaps, inquiries, or compliance issues regarding REMS.

Regularly monitor the regulatory compliance and REMS trends in the industry, interpret new regulations, guidance documents and enforcement activities, and evaluate the impact on the industry and the company. Communicate these insights to the Department and project teams in a timely manner.

Work with Regulatory Leadership Team to enhance systems, technology and processes. Ensure quality documents are defined, created, maintained and implemented globally in

accordance with Actelion requirements. In addition, provide local input on global SOPs as appropriate.

Other duties may be assigned. This job requires a combination of analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requirements

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4-6 years experience in pharmaceutical industry with at least 4 years experience in Regulatory Affairs.

Bachelor degree in related scientific discipline preferred or equivalent experience. In-depth knowledge of regulations and their implementation with specific experience in

the area of advertising and promotion. Experience with Subpart H or Risk MAP products preferred. Experience with Risk Evaluation and Mitigation Strategy (REMS) products preferred. Experience with FDA Inspection and internal quality audits preferred. Demonstrated leadership, interpersonal and collaboration skills, and ability to interact

with management and resolve conflicts. Strong negotiation and decision making skills. Must be able to provide creative solutions to complex problems. Excellent verbal, written, communication and presentation skills. Excellent organization skills, interpersonal skills and ability to work on a number of

projects with tight timeline. The ability to effectively prioritize and triage multiple activities/projects and understand

and interpret complex policies and directions. High degree of personal integrity and ethics.

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk and hear. The employee is required to frequently operate a personal computer and occasionally move about the facility. The employee must occasionally lift and/or move up to 15 pounds. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate. ********************************************************************* https://jobs.smartbrief.com/action/listing?listingid=E5B7970B-E79F-44C0-9A87-C1BC8ABC26F1&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 HEALTH CARE COMPLIANCE OFFICER Johnson & Johnson Job Description HEALTH CARE COMPLIANCE OFFICER (Job Number:0591130616) Description: Johnson & Johnson is looking for an HCC Officer for Acclarent Inc located in Menlo Park, California and Cordis Corporation located in Fremont California. The companies are part of the Johnson & Johnson family of companies in the Medical Device sector. This Officer position will provide HCC support and oversight for both companies. Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. Acclarent is a medical technology company dedicated to designing, developing and commercializing technologies that address conditions affecting the ear, nose and throat. The company was founded in 2004, was acquired by J&J in 2010. It is a growing company currently with about 350 employees, a US sales organization of about 150, and worldwide sales of approximately $200MM.

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Cordis Corporation is relocating the company's headquarters to Fremont, California. Cordis is a pioneer in less invasive treatments for vascular disease specializing in interventional medical procedures in cardiovascular, endovascular, and biliary duct (liver) treatments. Cordis sales are approximately $840MM worldwide with about 700 employees and a US sales organization of 225 people. As HCCO, the person in this position will serve as the HCC Officer for both Acclarent and Cordis providing support for the management boards, chairing its HCC Committees, and providing compliance support for key headquarters functions. HCC officers implement and maintain programs that support compliance with HCC laws, regulations and industry standards related to the promotion and marketing of health care products and services, interactions with health care professionals and/or government officials, including, as applicable to the business activities, FCPA and other anti-corruption laws, off-label promotion, anti-kickback and false claims statutes, compliance with corporate integrity agreements, deferred prosecution agreements or other settlements. The HCCO partners with company leadership (sales, marketing, R&D, HR, etc.,) to implement and maintain that Health Care Compliance programs that prevent and/or detect violations of law, regulations, and company policies. He/she will be acting as a consultant, reviewer and approver as needed, for business activities that involve HCC risks. This individual will be providing appropriate guidance, education, training, and regular communications on HCC to all relevant employees. He/she will support the risk assessment process, testing & monitoring efforts, external audits and reviews, corrective actions, response to reports of potential misconduct, and other elements of the companies' compliance programs. The Acclarent and Cordis HCCO will provide strategic support to senior management at the business units regarding potential compliance risks, compliance-related incidents and investigations, and trends, root causes, and recommend and implement appropriate action plans. He/she will participate in cross-company or cross-sector compliance initiatives within J&J, as necessary, and provide support to J&J HCC senior management. This individual will interface with legal counsel regarding HCC requirements and interpretation. The HCCO will partner with colleagues within the Global Surgery Group and J&J HCCP to drive the adoption of more efficient or effective HCC related practices. This individual will support the efficient implementation of the US Sunshine Act reporting obligations, and will analyze metrics at the operating company level and provide analysis to Global Surgery Group Leader and others as appropriate. The Acclarent and Cordis HCCO will manage a HCC Manager and have dotted line management of a second HCC manager who support the HCC programs at each operating company. This role includes actively engaging in the enterprise-wide Talent Management process for HCC to include establishing goals and objectives, giving direction, support, and periodic feedback to direct reports pursuant to Human Resources policies. He/she will provide technical subject matter expertise, advice and development opportunities to direct and indirect reports. Qualifications: A minimum of a Bachelors Degree is required. A minimum of 6 years of business experience, with at least five years in health care compliance, government contracts compliance or related compliance area is required. Current status as a Certified Compliance & Ethics Professional (CCEP®) or Certification in Healthcare Compliance (CHC®) preferred. Knowledge of healthcare fraud and abuse, anti-corruption and false claims laws is required. Knowledge of laws and regulations governing health care reimbursement is required. Knowledge of laws and regulations concerning the marketing and promotion of medical devices is required. Knowledge of financial or auditing practices is required. Knowledge of current standards and guidance concerning corporate compliance and ethics programs is required. Demonstrated experience in the development and implementation of a compliance program in accordance with the organization's risk profile is required. Exceptional written and verbal communications skills are required. Experience with project management in a matrixed business organization is preferred. Strong communication skills, organizational skills, and analytical skills are required. Broad business experience and a proven ability to influence

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business decisions and business partners are required. Ability to think strategically, develop and execute longer-term objectives is required. Ability to take complex business situations and develop solutions that ensure compliance is required. Proven track record in delivering results, self starter and ability to manage complexity is required. Ability to work well between functions and across all levels of the business and effective negotiating skills is required. Ability to comprehend and interpret legal documents is preferred. Proven success at managing and developing talent is required. This position will be located in Menlo Park, CA and Fremont, CA and will require up to 20% travel. Primary Location: North America-United States-California-Fremont Other Locations: Organization: Johnson & Johnson (6067) Job Function: Health Care Compliance ************************************************************************ https://jobs.smartbrief.com/action/listing?listingid=F93CE8E9-999A-4F9C-8FAD-626B6875D23F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Director, Reg Affairs Boston Scientific Job Description Purpose Statement: Responsible for a group of product lines, technology and specialized functions. Primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development. Key Responsibilities: · Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented. · Directs and coordinates the Regulatory Affairs department and related global submission activities. · Establishes departmental priorities to meet business objectives. · Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives. · Ensures compliance with all relevant regulations and guidelines. · Directs and coordinates the integration of acquired companies ensuring compliance and optimal achievement of business objectives. · Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation. · Manages relationships with local regulatory agencies and notified bodies. · Partners with Clinical Research to develop the most effective clinical trial strategies and protocols. · Advises divisional management team of prevailing and evolving global regulatory requirements and environment. · Develops, implements, and maintains departmental policies and procedures. · Provides regulatory guidance to divisional MDR reporting function. · Develops and manages departmental budget. · Provides support to corporate regulatory device listing and establishment registration documentation as appropriate. · Coordinates post-market approval activities.

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· Fosters employee career development. · Participates in trade and professional organizations. · Provides Regulatory Affairs training to manufacturing and development teams. · Provides regulatory support in new business development activities. · Fosters relationships with business partners to ensure regulatory compliance. Management Requirements: · May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. - Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. · May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations. - Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Qualifications: · Bachelor’s degree, Advanced degree preferred · 8 + years management experience in Reg Affairs required · Experience in Electrophysiology, particularly ablation, mapping or cardiac device experience preferred · Class II and Class III medical device experience required · Experience working with notified bodies for CE Marking required · Experience with IDE’s (Investigational Device Exemption) desired · Experience with original PMAs desired · Experience with FDA panel desired · Successful experience leading and managing a team · Ability to work cross-functionally with Operations, Clinical, PMO, R&D, Quality and Manufacturing · Demonstrated ability to manage company integration The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Please contact your local EH&S department for more information on physical requirements. ****************************************************************** For the opportunity below, please send resume to wd_darshana@hotmail.com. Software Quality Assurance Test Engineer - San Francisco, CA Other opportunities are posted in JOBS category at www.darshanavnadkarni.wordpress.com or at the link http://bit.ly/145kJ43 . SQA Test Engineer - SF, CA A software company that provides innovative, modular, scalable and world class solutions by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is scaling, in pre-funding stage. The company is expanding core engineering and product development team & looking for high caliber, senior, Quality Assurance Test Engineers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment. Responsibilities: Acquire in-depth understanding of the company’s products to ensure high quality of products; Support the development of workarounds, testing, necessary documentation (including investigation and resolution of issues; Assist in coordinating delivery

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management tasks; Track requirements and software release management for clients; Be first escalation point for supporting company’s customers. Requirements: Must have strong client support & project management background. Must have 4-6 years of implementation & post production support experience for enterprise applications; 3-4 years of functionality, testing, bug tracking, writing test cases experience; strong communication skills; demonstrable hands-on experience with quality management tools; technical skills in SQL, HTML based documentation. Highly preferred: skills in developing and managing on-line help content. Location: San Francisco Bay Area. Telecommuting is okay but will need to attend client team meetings – so must be in driving distance. Duration: 6-12 months, full to part-time, 1099, corp to corp, contract to hire. No visa sponsorships. *************************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=6482468&trk=jobs_seeking_view_job&goback=%2Evjs_6860208_*2_*2_*2_false_*2_*2 Pricing Analyst Karl Storz Endoscopy - Greater Los Angeles Area Job Description 2+ of Financial Analysis Consulting experience preferably from a big 4 consulting company. The Pricing Analyst is responsible for supporting the Pricing Director and Pricing Office team in the achievement of KSEA’s pricing strategies. Responsibilities: • Creates, maintains and advances a robust analytic and reporting platform for KSEA product pricing, market pricing, competitor data, market share and other relevant competitive market data • Support KSEA’s needs for reporting, scoreboards, and ad hoc analyses that provide transparency around KSEA’s pricing realization trends as well as market pricing trends • Interface with Sales management, either directly or indirectly, when requests for exception pricing are submitted to the Pricing Office • Develop personal expertise in KARL STORZ products, classifications of products, and the relative position of those products compared to competitors' products • Support KSEA marketing teams throughout the year and during pricing update exercises • Update data tables with new sales and product data on a monthly basis • Support related KSEA functional groups that also provide analytics and reporting: Financial Planning and Analysis group and the Business Planning group Professional competence: • Knowledge and use of tools, Access, Excel, PowerPoint etc. o Is expert at identifying, extracting and modeling relevant data to solve target solutions o Structures models independently o Develops slides independently • Working structured and analytical o Analyzes data in a structured approach with some up-front guidance o Interprets data correctly o Delivers accurate output o Develops alternative solutions and develops outside-the-box ideas • Makes efficient use of resources o Involves manager and team adequately o Makes use of and contributes to knowledge management

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o Uses own time efficiently o Identifies sources to acquire the know-how necessary o Seeks and identifies improvement potential within range of own tasks • Presentations: o Is able to present prepared findings to the team o Is able to answer specific questions within his area of responsibility o Manages/moderates a normal meeting or parts of a workshop with assistance • Identify and consider client agenda o Immediately understands problems of the client if they are addressed • Building and cultivating personal relationships o Is recognized by the client as contact person for his subjects Desired Skills & Experience Qualifications: Education Required: • Undergraduate degree in Finance, Accounting or similar • Strong technical/programming skills o Strong Access or equivalent database programming and data modeling skills o Excel modeling skills with ability to program macros using VBA code o On-going maintenance and upgrading of existing analytical tools (both Excel and Access) data architecture a plus • In depth understanding of financial data and financial statements and ability to use that knowledge to test and validate data outputs • Robust analytical skills and ability to utilize computer systems and related tools, including SAP, Microsoft Access, Excel, and Power Point • Ability to accept and execute with clear direction for on-going pricing office report distribution and communication • Excellent verbal & written skills; ability to communicate clearly with senior management Company Description The product range from KARL STORZ includes rigid and flexible endoscopes, instruments for the entire field of human medicine. Innovative products such as a fully digital video chain and KARL STORZ AIDA®, the central image and data archiving system, make for documentation that is convenient, comprehensive and high in quality. With the KARL STORZ OR1™ a visionary OR concept for minimally invasive surgery of the future has taken shape: it is a fully integrated OR, centrally monitored and controlled, in which surgical processes and routine work are simultaneously streamlined and simplified. KARL STORZ is an equal opportunity employer Additional Information Posted:July 18, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Medical Devices Job ID:6482468 ************************************************************************ Apply on company website Pricing Analyst NuVasive- San Diego (Greater San Diego Area)

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Job Description This A Player will be responsible for both pricing contracts and capital purchase quotes for hospitals in accordance with NuVasive pricing objectives, terms and conditions. - Ensure accuracy on outbound quotes and consistently meet the turn-around time promised to the sales force. - Decrease the gap between when pricing is presented to the hospital, and when it is accepted and loaded into SAP to minimize credit and re-bills. - This job requires someone who is an advanced user of Excel and has a high attention to detail. - This person must be able to multi-task in a very fast paced environment, meet deadlines, follow all steps and document all necessary information for audit purposes. - This person must be comfortable working in a growing company and be able to independently manage projects with little direction. - They need to be a self starter and someone who is constantly looking for ways to improve the process and efficiency of how things are done. Desired Skills & Experience - Follows all internal policies and procedures 100% of the time, is responsible for recording all required documentation and will help with the preparation of both internal and external audits. - Provide assistance to sales reps with strategic planning of quotes, this will require the Sales Coordinator to become an expert on all products, and different pricing strategies. - Provide analytic and operational support to sales force for standard and capital purchase quotes, for individual customer and GPO/IDN contracts and pricing strategies. Conduct other financial analysis to support pricing strategies as needed. - Support sales force with pricing strategy and rational behind corporate position to help facilitate positive outcomes in pricing discussions. - Provide sales force with reports/tools to gain visibility to open quotes in the field. - Monitor the group quotes email inbox and respond to all requests. - Responsible for coordinating multiple sales territories, must be responsive to all requests with consistent follow up and coordinate all required approvals. The Sales Coordinator will red-line RFP’s and also assist with obtaining all required documentation from the hospital. - Execute and monitor negotiated contracts from implementation to expiration and coordinate with pricing team to ensure that all accepted pricing is loaded into SAP and that any extensions or updates to the contract are updated in SAP within one day of hospital acceptance. - Support the pricing team to resolve pricing discrepancies and other related issues. Company Description NuVasive® is a medical device company focused on developing minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 4th largest player in the $8.2 billion global spine market. NuVasive’s principal product offering is based on its Maximum Access Surgery, or MAS® platform. The MAS platform combines several categories of solutions that collectively minimize soft tissue disruption during spine surgery with maximum visualization and safe, easy reproducibility for the surgeon: a proprietary software-driven nerve avoidance system and intra-operative monitoring support; MaXcess®, a unique split-blade retractor system; a wide variety of specialized implants; and several biologic products to aid in the spinal fusion process. MAS significantly reduces surgery time and returns patients to activities of daily living much faster than conventional approaches. Having redefined spine surgery with the MAS platform’s lateral approach, known as eXtreme Lateral Interbody Fusion, or XLIF®, NuVasive has built an entire spine franchise. With over 80 products today spanning lumbar, thoracic and cervical applications, the Company will continue to expand and evolve its offering predicated on its R&D focus and dedication to outstanding service levels supported by a culture of Absolute Responsiveness®. Additional Information Posted:August 15, 2013 Type:Full-time

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Experience:Mid-Senior level Functions:Analyst Industries:Medical Devices Employer Job ID:1406-151 Job ID:6860208 ******************************************************************* Contact cheryl@biophaseinc.com if interested! Be sure to visit www.biophaseinc.com to view all our latest job opportunities. Surface Chemist (Redwood City) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Surface Chemist to work for a leading Bay Area biotechnology company. Surface Chemist We are recruiting for a Surface Chemist to join our fast growing start-up client in Next Generation Sequencing technology. This position is direct-hire full time and located in Redwood City, CA. Ph.D level surface chemist with extensive experience in ligand conjugation chemistry both in solution and on solid surfaces, experience with chemical surface characterization and chemical derivatization of surfaces and soluble molecules A minimum of 5 years experience developing products or assays Thorough knowledge of the biochemistry of proteins and nucleic acids and hands-on experience working with biomolecules Experience working with biomolecules in the context of microchannels and microfluidic devices Proven ability to independently design studies, define goals, produce experimental plans, execute experiments, do in-depth data analysis and present results and conclusions for internal and external review A plus if experience with product development, process transfer, manufacturing scale-up, quality control procedures and controlled documentation processes Innovative, driven, results-oriented and methodical, with record of achievement commensurate with previous experience Leadership skills, ability to collaborate within a multidisciplinary organization and used to work within tight schedules Extensive publications Experience in product development with next generation sequencing in industry or academia. ********************************************************************** There are 383 jobs listed at the new Bio Jobs: The Talent Hub for Biotech on the BIO website. I’ve listed the first 75 in California that were posted since August 4, 2013 to give you idea of variety. See more at: http://jobs.bio.org/jobseeker/search/results/state/California#sthash.VtzQuFQm.dpuf Scientist, Biology (Ophthalmology/Vision Science) Allergan

Irvine, California, United States 08/14/2013

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Project Lead, Development Lpath, Inc.

San Diego, California, United States 08/08/2013 San Francisco, California, United States Chicago, Illinois, United States More... 08/06/2013 QA Director AmpliPhi Biosciences

San Diego, California, United States 08/06/2013 Biologist - Edwards Air Force Base, California CH2M HILL

Lancaster, California, United States 08/05/2013 Postdoctoral fellow University of California San Francisco

San Francisco, California, United States 08/04/2013 Director Assay Development HTS (1534_0010763676-01-1) Novartis Institute For Functional Genomics, Inc.

San Diego, California, United States 08/04/2013 Jobs from the Web Research Assistant II, Biology California Institute for Biomedical Research La Jolla, CA, US 08/06/2013

Calibration Technician IV - Los Angeles, CA area Tektronix

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Medical Writer, Neurology Allergan, Inc. Irvine, CA, US 08/10/2013 Biologist - Edwards Air Force Base, California CH2M HILL Lancaster, CA, US 08/06/2013 Programmer / Analyst (SQL, Perl, Java, Unix) Althea Dx San Diego, CA, US 08/05/2013 CBG Associate II City Of Hope Duarte, CA, US 08/14/2013 Staff Scientist City Of Hope Duarte, CA, US 08/12/2013 Associate Director - High Throughput Screening Vertex Pharmaceuticals San Diego, CA, US 08/09/2013 Scientist Genentech South San Francisco, CA, US 08/14/2013

Regulatory Medical Writer (home based)

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San Francisco, CA, US 08/08/2013 Scientific Manager, BioAnalytical Sciences Genentech South San Francisco, CA, US 08/13/2013 Associate Director - High Throughput Screening San Diego, CA, US 08/10/2013

Sterilization Microbiologist - Cor-Tech LLC Temecula, CA, US 08/06/2013

Sr Mgr, HW Engineering - Healthcare Diagnostics Sacramento, CA, US 08/05/2013

Senior QC Associate Genentech Vacaville, CA, US 08/08/2013

Research Associate Randstad Pharma Novato, CA, US 08/05/2013

Baxter

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Research Associate II - Diagnostic Illumina, Inc San Diego, CA, US 08/15/2013 Sr. Manager, Biomarker Foster City, CA, US 08/08/2013 Senior Microbiologist Siemens Corporation West Sacramento, CA, US 08/13/2013 Microbiologist 2 - Clinical Affairs Siemens Corporation West Sacramento, CA, US 08/13/2013 Microbiologist 2 Siemens Corporation West Sacramento, CA, US 08/11/2013 Terrestrial Biologist Environmental Scientist Business Unit Marketing Manager (D13-044) Reimbursement Specialist TearLab, Inc San Diego, CA, US 08/14/2013 Director, Quality

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Thousand Oaks, CA, US 08/05/2013 Jobs from the Web Statistical Geneticist Focusing On Parkinson's Disease 23 and Me Mountain View, CA, US 08/10/2013 Accounts Payable Clerk TearLab San Diego, CA, US 08/15/2013 Research Associate III - Molecular Biology Fisher Scientific Los Angeles, CA, US 08/13/2013 Associate Scientist III - R&D Superior Group Carlsbad, CA, US 08/13/2013 Director Quality Baxter Thousand Oaks, CA, US 08/11/2013 Associate Director - Cancer Diagnostics, Center for Cancer Research SRI International Menlo Park, CA, US 08/07/2013 Document Control Coordinator

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TearLab San Diego, CA, US 08/15/2013 Assistant Biochemist ON-BOARD SERVICES San Diego, CA, US 08/08/2013 Accountant AltheaDx San Diego, CA, US 08/09/2013 Medical Writer- regulatory Contract through Green Key Resources San Diego, CA, US 08/07/2013 CRO Business Development Manager-US based (for Asia Pacific territory) Clinical Blend, LLC San Diego, CA, US 08/10/2013 Clinical Research Associate/Biostatistics CosignMed Fremont, CA, US 08/10/2013 Staff Research Associate I - FT NICRE San Francisco, CA, US 08/07/2013 - See more at: http://jobs.bio.org/jobseeker/search/results/state/California#sthash.VtzQuFQm.dpuf ********************************************************************

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http://www.linkedin.com/jobs?viewJob=&jobId=6232334&trk=jobs_seeking_view_job&goback=%2Evjs_6827977_*2_*2_*2_false_*2_*2 Senior Clinical Trial Manager, Pharmaceutical Valesta Clinical Research Solutions- San Francisco Bay Area Job Description Senior Clinical Trial Manager, Oncology / Infectious Disease San Francisco Bay area Growing clinical stage biopharmaceutical client located in the San Francisco Bay area has an immediate need to hire a full time Senior Clinical Trial Manager. Their pipeline includes oncology and infectious disease pharmaceutical products. The Sr. Clinical Trial Manager will be responsible for overseeing multiple clinical trials including all clinical operations responsibilities (budgets, timelines, vendor selection, etc.). The Sr. Clinical Trial Manager will also provide oversight of clinical team staff during study start-up, interim monitoring and closeout activities. Desired Skills & Experience Position Requires:

Bachelor's Degree (or higher) and a minimum of 8 years of pharmaceutical industry clinical research experience with a minimum of 3 years of management level experience.

Must have experience with managing multiple clinical trials simultaneously and strong clinical operations background.

Must have prior direct report management experience and Oncology and/or Infectious disease experience.

Ability to travel up to 25% required. Company Description Valesta Clinical Research Solutions (Valesta) is a leading provider of skilled clinical research professionals at all career levels for project-based, contract-to-hire, and direct hire opportunities. Our dedicated Account Executives thoroughly understand the industries they serve and offer resourcing solutions in specialized areas, such as clinical data, clinical monitoring, medical writing, biometrics, and regulatory affairs. In 2011, Valesta joined forces with the clinical research division of On Assignment forming a partnership that strengthened our ability to offer comprehensive resourcing services to our clients for both their domestic and international locations. Valesta offices are located in Mechelen and Wavre, Belgium; Madrid and Barcelona, Spain; and Den Bosch, Netherlands; with five branch offices in the United States, including California, Connecticut, Pennsylvania, North Carolina, and Illinois. Valesta Clinical Research Solutions Additional Information Posted:August 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:6232334 *********************************************************************** Posted by Lauri Loris at Lauri.Loris@InVentivhealth.com http://www.linkedin.com/jobs?viewJob=&jobId=6232334&trk=jobs_seeking_view_job&goback=%2Evjs_6827977_*2_*2_*2_false_*2_*2 Senior Clinical Trial Manager, Pharmaceutical Valesta Clinical Research Solutions- San Francisco Bay Area Job Description Senior Clinical Trial Manager, Oncology / Infectious Disease

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San Francisco Bay area Growing clinical stage biopharmaceutical client located in the San Francisco Bay area has an immediate need to hire a full time Senior Clinical Trial Manager. Their pipeline includes oncology and infectious disease pharmaceutical products. The Sr. Clinical Trial Manager will be responsible for overseeing multiple clinical trials including all clinical operations responsibilities (budgets, timelines, vendor selection, etc.). The Sr. Clinical Trial Manager will also provide oversight of clinical team staff during study start-up, interim monitoring and closeout activities. Desired Skills & Experience Position Requires:

Bachelor's Degree (or higher) and a minimum of 8 years of pharmaceutical industry clinical research experience with a minimum of 3 years of management level experience.

Must have experience with managing multiple clinical trials simultaneously and strong clinical operations background.

Must have prior direct report management experience and Oncology and/or Infectious disease experience.

Ability to travel up to 25% required. Company Description Valesta Clinical Research Solutions (Valesta) is a leading provider of skilled clinical research professionals at all career levels for project-based, contract-to-hire, and direct hire opportunities. Our dedicated Account Executives thoroughly understand the industries they serve and offer resourcing solutions in specialized areas, such as clinical data, clinical monitoring, medical writing, biometrics, and regulatory affairs. In 2011, Valesta joined forces with the clinical research division of On Assignment forming a partnership that strengthened our ability to offer comprehensive resourcing services to our clients for both their domestic and international locations. Valesta offices are located in Mechelen and Wavre, Belgium; Madrid and Barcelona, Spain; and Den Bosch, Netherlands; with five branch offices in the United States, including California, Connecticut, Pennsylvania, North Carolina, and Illinois. Valesta Clinical Research SolutionsAdditional Information Posted:August 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:6232334 ********************************************************************* Senior Clinical Trial Manager InVentivHealth Clinical- South San Francisco, CA (San Francisco Bay Area) Job Description Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in Company’s early development portfolio: • Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) • Develop program timelines and budgets and manage variance • Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans • Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget • Develop and present operational plan to management review bodies

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• Identify program risks and develop and implement mitigation strategies for assigned programs • Define the resourcing and outsourcing strategy for early development programs • Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders • Partner with Business Management to identify strategic business needs to support the clinical programs • Partner with late-stage development leaders to ensure strategic alignment on the CDP • Resource projects to enable teams to meet deliverables • Create a positive work environment by encouraging mutual respect, innovation and accountability Minimum: • 10+ years experience of clinical and drug development, including 5+ years of clinical trial management experience, with expertise in any area of Infectious Disease, Cardio, CNS, Immunology, Respiratory • 2+ years of clinical program management experience • Functional management experience preferred • Experience in early phase clinical development • Bachelors Degree or equivalent required (scientific or healthcare discipline preferred). Advanced degree preferred • Working knowledge of international regulatory and ICH GCP guidelines Experience, Skills, Knowledge: • Demonstrated understanding, knowledge, and experience of drug development with particular focus on early development • Demonstrated experience in various therapeutic areas • Strong analytical and strategic agility skills • Excellent planning and organizational skills • High level of initiative and ability to work independently • Exceptional leadership skills, including motivation and delegation Education: • Bachelors Degree or equivalent required (scientific or healthcare discipline preferred). Advanced degree preferred Desired Skills & Experience MUST have at least 5 years of experience This is a salaried position with InVentiv Health Clinical Additional Information Posted:August 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals, Biotechnology Job ID:6827977 ********************************************************************* Hiring for Entry level/Junior Pharmaceutical Sales Representative, PCP Diabetes at Northridge, CA and looking for suitable candidates. Single Click Job Sharing on Multiple Linkedin Groups with Wisestep.com. Apply Online: http://www.wisestep.com/RLFNQUQL/IRAGCIGFAI or Share with Friends. Job Description: This is a 4 yr. engagement. The primary objective of the sales representative is to meet established sales goals by

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delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Qualifications/Experience 4 year Bachelor degree required MUST HAVE Minimum 1 year of successful Business to Business sales experience or similar related experience (e.g. Nursing, CDE Certified Diabetes Educator, Pharmaceutical Sales, College Graduate with transferable experiences/skills) required MUST HAVE Demonstrated ability to learn and apply technical and scientific product-related information Demonstrated ability to manage territory budget Consistent track record of quantifiable/documented sales accomplishments Demonstrated ability to plan, analyze and act upon sales data within an assigned geography Solid business acumen including excellent and persuasive business communication Demonstrated ability to work independently and exercise good business judgment and discretion and to analyze and address territory opportunities and build key customer relationships Ability to travel as necessary is required Residence within the current geography is required ************************************************************************ If you are qualified and interested please contact me privately at dave@alpinesearch.net Dave Murphy The Alpine Group www.alpinesearch.net Director of Consumer / DTP Marketing: Southern California To view a brief video about this opportunity click here: http://youtu.be/V36dgJPAkJU A midsize client of mine in the biopharma industry has asked me to help them fill a Director of Consumer Marketing role, leading all patient and consumer marketing for two different product lines. This is a very immature market so the focus is on market development and expansion. Since there is no direct competition for their products patient education and consumer marketing will be crucial to their success, so the role will be fairly high-profile. Qualifications: - 7 years of pharmaceutical marketing experience, including product launch - 3+ years of Consumer / Patient Marketing in the pharma industry - Experience coordinating ad agencies, PR firms and social media programs ********************************************************************** Apply on company website Commercial Production Mngr, Drug Product @ Pharmacyclics in Sunnyvale Commercial Production Managrr, Drug Product Job Code:11-HC-1 Primarily responsible for the production of commercial drug product intended for world-wide distribution. Oversight of drug product manufacturing activities at contract manufacturing organizations. Responsibility for post-approval strategies and continued process verification activities. Represent commercial manufacturing both as part of cross-functional teams and to business partners. Key Accountabilities/Core Job Responsibilities:

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* Provide leadership and oversight to all aspects of the commercial production of drug product at contract manufacturing organizations (CMO) * Interact with the supply chain group at Pharmacyclics to monitor and direct the drug product production schedule in accordance with the supply forecast. * Champion improvement and optimization of the drug product manufacturing process. Develop strategies for implementation of post-approval changes in the context of world-wide regulatory considerations and with minimal impact to ongoing business strategies.. * Create and maintain manufacturing database and lead continued process verification efforts. Compile and interpret intra- and inter- batch data to assess variability and formulate strategies to minimize and improve process control. * Provide technical review of batch records and associated documents for commercial drug products manufactured at the CMO. Function as technical expert to formulate solutions to complex manufacturing issues. Collaborate with internal quality organizations to enable timely lot release and issue resolution. . * As necessary, function as Person-In-Plant to oversee GMP manufacturing operation performed at CMO site. Formulate solutions to complex manufacturing issues. Requirements Qualifications and Experience: * Experienced background in solid dosage form manufacturing processes. Experience in managing CMO’s required. * Thorough understanding of regulatory guidance as applied to solid dosage forms and post-approval changes * Relevant experience in process validation and continued process verification * Advanced data and statistical analysis skills as applied to process improvement and optimization activities. * Excellent organizational and time management skills. Team Player. * Advanced communication and technical writing skills. * Strong strategic planning ability as well as detail-oriented thinking required. * 10 + years of relevant experience in the pharmaceutical industry. Level and salary commensurate with experience. Education Requirements: * BS in an engineering or scientific discipline. ********************************************************************** https://jobs.smartbrief.com/action/listing?listingid=F93CE8E9-999A-4F9C-8FAD-626B6875D23F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0 Director, Reg Affairs Boston Scientific Job Description Purpose Statement: Responsible for a group of product lines, technology and specialized functions. Primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development. Key Responsibilities: · Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.

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· Directs and coordinates the Regulatory Affairs department and related global submission activities. · Establishes departmental priorities to meet business objectives. · Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives. · Ensures compliance with all relevant regulations and guidelines. · Directs and coordinates the integration of acquired companies ensuring compliance and optimal achievement of business objectives. · Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation. · Manages relationships with local regulatory agencies and notified bodies. · Partners with Clinical Research to develop the most effective clinical trial strategies and protocols. · Advises divisional management team of prevailing and evolving global regulatory requirements and environment. · Develops, implements, and maintains departmental policies and procedures. · Provides regulatory guidance to divisional MDR reporting function. · Develops and manages departmental budget. · Provides support to corporate regulatory device listing and establishment registration documentation as appropriate. · Coordinates post-market approval activities. · Fosters employee career development. · Participates in trade and professional organizations. · Provides Regulatory Affairs training to manufacturing and development teams. · Provides regulatory support in new business development activities. · Fosters relationships with business partners to ensure regulatory compliance. Management Requirements: · May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. - Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. · May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations. - Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Qualifications: · Bachelor’s degree, Advanced degree preferred · 8 + years management experience in Reg Affairs required · Experience in Electrophysiology, particularly ablation, mapping or cardiac device experience preferred · Class II and Class III medical device experience required · Experience working with notified bodies for CE Marking required · Experience with IDE’s (Investigational Device Exemption) desired · Experience with original PMAs desired · Experience with FDA panel desired · Successful experience leading and managing a team · Ability to work cross-functionally with Operations, Clinical, PMO, R&D, Quality and Manufacturing · Demonstrated ability to manage company integration The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

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Jobs That Crossed My Desk Through August 11, 2013 ************************************************************************ Posted by Stephen Danyla, Talent Acquisition Professional http://www.linkedin.com/jobs?viewJob=&jobId=6784822&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=3oHRJNcap0-BQ1 Validation Engineers/Specialists Validation Technologies, Inc.- Greater Los Angeles, CA Area (Greater Los Angeles Area) Job Description Strategic career opportunity to join a dynamic team of technical experts! Validation Technologies, Inc. (VTI) is currently looking to identify multiple Validation Specialists to join our team in the Greater Los Angeles, CA area. WE ARE IMMEDIATELY SEEKING QUALIFIED CANDIDATES WITH STRONG VALIDATION EXPERIENCE IN: CLEANING CONTROLS AUTOCLAVES DeltaV EQUIPMENT PROCESS MATERIALS PLC AUTOMATION Desired Skills & Experience

A minimum Bachelor's degree in a related science (Engineering, Chemistry, Analytical or Bio-Analytical, Biology, Life Science) or equivalent work experience.

Experience working in a FDA Regulated enviroment. A thorough knowledge of Good Documentation Practices (cGDP) and excellent verbal

and written communication skills. Experience in writing technical documents, including validation documents, protocols,

and reports Excellent interpersonal skills, coupled with a superb attention to detail, excellent review

skills and analytical skills. Must have strong ability to organize and manage multiple tasks in a fast-paced

environment. The ability to work effectively with team members and work under minimal supervision

Company Description Validation Technologies, Inc. (VTI), an ISO 9001:2000 Certified Company, strives to maintain and inspire professional excellence by providing Commissioning, Qualification and Validation Services to the Pharmaceutical, Biotech, Biologics and Medical Devices Industries. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence. We offer some of the best salary and benefits packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors. As one of the leading global Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. Additional Information Posted:August 9, 2013 Type:Full-time ExperienceMid-Senior level Functions:

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Engineering, Manufacturing Industries:Biotechnology, Pharmaceuticals Job ID:6784822 Veteran Commitment

Validation Technologies, Inc. commits to hiring returning veterans. Learn more » This employer commits to hiring veterans. LinkedIn has partnered with NRD.gov to help veterans find jobs. *********************************************************************** See extensive listing of jobs in California and elsewhere at Novartis. Listing is changing all the time according to Romain Taniere who shared this information with me. http://www.novartis.com/careers/job-search/index.shtml#country=US&division=Pharma AD, Regulatory Affairs 109525BR Director, Clinical Manufacturing 120878BR Director, Drug Delivery 117259BR Finance Manager, Reporting, Planning & Compliance 120515BR Manufacturing Tech III 122996BR Peer Review and Development Coordinator 125534BR Process Development Engineer II 124002BR Process Expert 112757BR Process Unit Coordinator 124734BR Process Unit Engineer-96347BR 111948BR Process Unit Facilitator 124760BR QA Specialist (GMP Officer)_SWING SHIFT 109936BR QC Analytical Chemist 125159BR Reg CMC Facilitator 117144BR Research Associate II 123484BR Research Associate III 123099BR Research Associate III, Analytical R &D 122740BR Scientist 123019BR Senior Design Engineer 124762BR USA Senior Research Associate 122746BR Site Manufacturing Science & Tech Head 121803BR Sourcing Manager 120236BR Staff Design Engineer 125631BR Staff Project Engineer 121531BR Staff Project Engineer 124646BR Strategic Sourcing Expert 124826BR ********************************************************************* Apply on company website Clinical Data Manager Medivation- San Francisco, CA (San Francisco Bay Area) Job Description Medivation, Inc. (NASDAQ: MDVN – www.medivation.com), a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Clinical Data Manager, reporting directly to the Associate Director Clinical Data Management.

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The successful candidate will have the skills necessary to thrive in a small company environment, as the Clinical Data Manager will be responsible for providing timely, professional, and precise ongoing quality management of clinical trial data in a fast-paced, rapidly-evolving environment. The Clinical Data Manager will lead the data review cycle by implementing the data validation plan, identifying potential data issues not currently covered in the validation plan, and fielding ad hoc requests for data listings from other functions such as clinical, biostatistics, and medical affairs. The Clinical Data Manager is responsible for tracking important study metrics on data entry, source verification, and query status, for performing quality control on those metrics to ensure accuracy, and for presenting those metrics to the cross-functional team in weekly meetings. The successful candidate will have the ability to gather, organize, and analyze clinical data and metadata from multiple data sources and can take over current methodologies as well as implement alternatives. Particularly important skills include intelligence, logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills. Essential duties and responsibilities but not limited to the following:

Manage and coordinate the activities of internal team and external vendors Plan, organize, and coordinate global data management activities on a study basis Ensure database consistency within a study Review data management performance against established metrics Work with urgency and high level of attention to detail Identify issues and create training tools for site and field staff Participate in internal study team meetings as well as teleconferences with outside

vendors and study personnel; update the teams on study metrics and provide ad hoc training

Write data management sections of study newsletters Desired Skills & Experience Requirements

Experience leading the lock of a phase 2 or 3 oncology study, breast or prostate cancer preferred, in an electronic data capture platform

7 - 10 years experience in clinical data management at a biotechnology company or Contract Research Organization

Experience in the use of data standards (CDISC, CDASH, HL7) in the clinical trial environment

Basic knowledge of SAS in order to spec out listing requests to statistical programming department

Experience with InForm 5.0 a plus Education:

B.S. or B.A. required, M.S. or M.A. preferred Company Description Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel therapies to treat serious diseases for which there are limited treatment options for patients in need. Medivation blends a unique business model with an expert team to bring promising medical technologies to patients. Medivation is made up of a vibrant, energized group of employees that are proud to be working for an innovative biopharmaceutical company. Medivation’s shared culture is evident through the trust and passion that employees exhibit. Medivation has created a unique community where employees are committed to making a difference in the lives of patients. Medivation launched its first approved product in September 2012. Medivation is a rapidly growing company with 300+ employees, located in beautiful San Francisco. Additional Information Posted:July 23, 2013 Type:Full-time

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Experience:Mid-Senior level Functions:Science Industries:Pharmaceuticals Job ID:6516564 ********************************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=6731989&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=2NltxazQhxY5Q1 Project Data Manager Theorem Clinical Research- Remote in California (San Francisco Bay Area) Job Description Project Data Manager Status: Permanent/Salaried Location: Remote (California) JOB SUMMARY Supervise and mentor assigned Clinical Data Management staff. Manage project budgets, timelines, resource planning, and overall quality of data management services of assigned projects/sponsors. JOB RESPONSIBILITIES - Evaluate and manage project budget against project milestones to ensure project profitability. Take corrective measures where necessary to keep project in line with budget and profit expectations. Track scope changes and obtain sponsor approval for change orders. Review, approve and follow-up on sponsor invoices. - Supervisory position managing activities of Clinical Data Management staff assigned to specific sponsors. Perform Annual Employee Performance Evaluations. - Establish appropriate project tracking using computer assisted programs and ensure timely entry of project information. Ongoing QC review of posted study documentation in study portal and in PMF for completion and audit readiness. - Manage timelines for assigned protocol(s) and ensure that all applicable Clinical Data Management staff are aware and on target for all sponsor company deliverables. Manage sponsor expectations with regards to scope of work and deliverables. Ensure efficient cross functional handoffs. - Escalate any potential or actual issues to supervisor, project team, and/or sponsor company in a timely manner with suggested resolution, and follow issues through to resolution. - Ensure that Clinical Data Management staff documents initial and ongoing training as required by both Theorem and the sponsor company. - Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation. - Present CDM function at conferences, external non-study meetings, etc. Attend Bid Defense Meetings and provide input into proposals as requested. Desired Skills & Experience KEY SKILLS & BEHAVIORS - Exemplifies, delivers and expects professionalism using strong interpersonal and organizational skills. - Keeps internal and external sponsors informed of project and/or technical issues by pro-actively communicating across teams/functions. - Manages and directly supervises assigned clinical data management team. - Communicates effectively through both written and verbal methods. - Anticipates changing priorities and demands and addresses them proactively. - Manages time effectively in order to produce quality deliverables in expected timeframe. - Exemplifies, delivers and expects professionalism using strong interpersonal and organizational skills. TRAINING AND EXPERIENCE

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1. Medical/Nursing, Life Science/Mathematical Degree or relevant experience. 2. 6+ yrs. experience, of which 2 yrs. must have been as Data Manager (or proven managerial experience); Experience leading multiple studies simultaneously. Company Description Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM. Theorem Clinical ResearchAdditional Information Posted:August 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:6731989 _______________________________________________________________ Posted by Jim Doyle, Senior Recruiter http://www.linkedin.com/jobs?viewJob=&jobId=6783375&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=1TUFJ8Ouh4-BQ1 Sr. Project Statistician Theorem Clinical Research- Remote in California (San Francisco Bay Area) Job Description Sr. Project Statistician Status: Permanent, Salaried Location: Remote SUMMARY Statistician who should be able to analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients. RESPONSIBILITES •Manage Biometrics project teams and track department project activities (including project revenue) and provide status updates. •Represent department on interdepartmental project teams. •Serve as contact with clients for statistical aspects of clinical studies. •May serve as project leader for “back-end” projects involving multiple studies. •Assist in establishing departmental processes, interaction with other departments, training of staff and other departmental administrative duties. •Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate safety and basic and complex efficacy shell data displays •Conduct all statistical analyses in support of clinical research studies. •Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets. •Perform quality control of complex efficacy analysis datasets and supervise quality control of safety and all efficacy analysis datasets. •Perform validation and quality control of complex efficacy data displays and supervise validation and quality control of safety and all

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efficacy data displays that show inferential statistics. •Write statistical reports and statistical section of the clinical study report (CSR). •Write a charter for independent data monitoring committee (IDMC). •Prepare detailed statistical analysis plans for a single project and for an integrated summary of safety (ISS) and an integrated summary of efficacy. •Review and approve case report form (CRF) design, data management plan, and edit specifications for a clinical trial. •Able to present at bid defenses for Biometrics. •Able to properly review CSRs to ensure appropriate representation of statistical methodology and inference. •Respond to sponsor audit and ability to write standard operating procedures (SOPs). •Able to mentor new hire statisticians. •Resolve problems that arise while performing tasks. •Perform quality control of datasets and data displays for integrated summary of efficacy (ISE); supervise quality control of datasets and data displays for ISS and ISE. •Produce quality deliverable within timelines and with customer satisfaction. •Attain effective time management skills. •Attain effective understanding and use of the ICH Guidelines E3, E9, and E10. •Maintain project administration file, including protocol, annotated CRF, statistical analysis plan, annotated shells for data displays, programming and quality control rules, tracking of generation and quality control of data displays, and project communication (internal and client). •Maintain project directories on computer systems, including ensuring that final SAS output is in the correct directory, and that all interim programs and output are deleted at the completion of the project. •Handle miscellaneous tasks as assigned by management. Desired Skills & Experience TRAINING & EXPERIENCE •Masters degree/Ph.D. in Statistics/Biostatistics or equivalent. •4-6 years for M.S. and 3-5 years for Ph.D. in clinical data experience. •No special physical demands. •Major part of work done in office environment. •Some travel required for project team meetings. •High degree of accuracy and attention to detail. •Proficient in SAS and ability to program using SAS macro language. •Proficient in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques. •Excellent project management and organizational skills. KEY SKILLS & BEHAVIORS •Work extensively with Biometrics project team members •Interact with other members of Company and client project teams. •Respond to questions from clients •Effectively communicate data findings to the data manager. •Effectively communicate results to Company and client clinicians and project managers, and client statistician. •Ability to present statistical methodology and trial results to various audiences. Company Description Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base

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comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM. Theorem Clinical ResearchAdditional Information Posted:August 9, 2013 Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:6783375 _____________________________________________________________________ Posted by Jim Doyle, Senior Recruiter http://www.linkedin.com/jobs?viewJob=&jobId=6783271&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=1hMO8Vxn96-BQ1 Sr. Project Statistician Theorem Clinical Research - Remote in California (Greater San Diego Area) Job Description Sr. Project Statistician Status: Permanent, Salaried Location: Remote (California) SUMMARY Statistician who should be able to analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients. RESPONSIBILITES •Manage Biometrics project teams and track department project activities (including project revenue) and provide status updates. •Represent department on interdepartmental project teams. •Serve as contact with clients for statistical aspects of clinical studies. •May serve as project leader for “back-end” projects involving multiple studies. •Assist in establishing departmental processes, interaction with other departments, training of staff and other departmental administrative duties. •Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate safety and basic and complex efficacy shell data displays •Conduct all statistical analyses in support of clinical research studies. •Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets. •Perform quality control of complex efficacy analysis datasets and supervise quality control of safety and all efficacy analysis datasets. •Perform validation and quality control of complex efficacy data displays and supervise validation and quality control of safety and all efficacy data displays that show inferential statistics. •Write statistical reports and statistical section of the clinical study report (CSR). •Write a charter for independent data monitoring committee (IDMC). •Prepare detailed statistical analysis plans for a single project and for an integrated summary of safety (ISS) and an integrated summary of efficacy.

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•Review and approve case report form (CRF) design, data management plan, and edit specifications for a clinical trial. •Able to present at bid defenses for Biometrics. •Able to properly review CSRs to ensure appropriate representation of statistical methodology and inference. •Respond to sponsor audit and ability to write standard operating procedures (SOPs). •Able to mentor new hire statisticians. •Resolve problems that arise while performing tasks. •Perform quality control of datasets and data displays for integrated summary of efficacy (ISE); supervise quality control of datasets and data displays for ISS and ISE. •Produce quality deliverable within timelines and with customer satisfaction. •Attain effective time management skills. •Attain effective understanding and use of the ICH Guidelines E3, E9, and E10. •Maintain project administration file, including protocol, annotated CRF, statistical analysis plan, annotated shells for data displays, programming and quality control rules, tracking of generation and quality control of data displays, and project communication (internal and client). •Maintain project directories on computer systems, including ensuring that final SAS output is in the correct directory, and that all interim programs and output are deleted at the completion of the project. •Handle miscellaneous tasks as assigned by management. Desired Skills & Experience TRAINING & EXPERIENCE •Masters degree/Ph.D. in Statistics/Biostatistics or equivalent. •4-6 years for M.S. and 3-5 years for Ph.D. in clinical data experience. •No special physical demands. •Major part of work done in office environment. •Some travel required for project team meetings. •High degree of accuracy and attention to detail. •Proficient in SAS and ability to program using SAS macro language. •Proficient in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques. •Excellent project management and organizational skills. KEY SKILLS & BEHAVIORS •Work extensively with Biometrics project team members •Interact with other members of Company and client project teams. •Respond to questions from clients •Effectively communicate data findings to the data manager. •Effectively communicate results to Company and client clinicians and project managers, and client statistician. •Ability to present statistical methodology and trial results to various audiences. Company Description Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful

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trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM. Additional Information Posted:August 9, 2013 Type:

Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:6783271 ____________________________________________________________________ Posted by Jim Doyle http://www.linkedin.com/jobs?viewJob=&jobId=6782754&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=3bp7KJvEJ8-BQ1 Sr. Project Statistician Theorem Clinical Research - Remote in California (Orange County, California Area) Job Description Sr. Project Statistician Status: Permanent, Salaried Location: Remote (California) SUMMARY Statistician who should be able to analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients. RESPONSIBILITES •Manage Biometrics project teams and track department project activities (including project revenue) and provide status updates. •Represent department on interdepartmental project teams. •Serve as contact with clients for statistical aspects of clinical studies. •May serve as project leader for “back-end” projects involving multiple studies. •Assist in establishing departmental processes, interaction with other departments, training of staff and other departmental administrative duties. •Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate safety and basic and complex efficacy shell data displays •Conduct all statistical analyses in support of clinical research studies. •Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets. •Perform quality control of complex efficacy analysis datasets and supervise quality control of safety and all efficacy analysis datasets. •Perform validation and quality control of complex efficacy data displays and supervise validation and quality control of safety and all efficacy data displays that show inferential statistics. •Write statistical reports and statistical section of the clinical study report (CSR). •Write a charter for independent data monitoring committee (IDMC). •Prepare detailed statistical analysis plans for a single project and for an integrated summary of safety (ISS) and an integrated summary of efficacy. •Review and approve case report form (CRF) design, data management plan, and edit specifications for a clinical trial. •Able to present at bid defenses for Biometrics.

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•Able to properly review CSRs to ensure appropriate representation of statistical methodology and inference. •Respond to sponsor audit and ability to write standard operating procedures (SOPs). •Able to mentor new hire statisticians. •Resolve problems that arise while performing tasks. •Perform quality control of datasets and data displays for integrated summary of efficacy (ISE); supervise quality control of datasets and data displays for ISS and ISE. •Produce quality deliverable within timelines and with customer satisfaction. •Attain effective time management skills. •Attain effective understanding and use of the ICH Guidelines E3, E9, and E10. •Maintain project administration file, including protocol, annotated CRF, statistical analysis plan, annotated shells for data displays, programming and quality control rules, tracking of generation and quality control of data displays, and project communication (internal and client). •Maintain project directories on computer systems, including ensuring that final SAS output is in the correct directory, and that all interim programs and output are deleted at the completion of the project. •Handle miscellaneous tasks as assigned by management. Desired Skills & Experience TRAINING & EXPERIENCE •Masters degree/Ph.D. in Statistics/Biostatistics or equivalent. •4-6 years for M.S. and 3-5 years for Ph.D. in clinical data experience. •No special physical demands. •Major part of work done in office environment. •Some travel required for project team meetings. •High degree of accuracy and attention to detail. •Proficient in SAS and ability to program using SAS macro language. •Proficient in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques. •Excellent project management and organizational skills. KEY SKILLS & BEHAVIORS •Work extensively with Biometrics project team members •Interact with other members of Company and client project teams. •Respond to questions from clients •Effectively communicate data findings to the data manager. •Effectively communicate results to Company and client clinicians and project managers, and client statistician. •Ability to present statistical methodology and trial results to various audiences. Company Description Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM. Theorem Clinical ResearchAdditional Information Posted:August 9, 2013

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Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:6782754 ********************************************************************** Please send your resume to: amanda.rodriguez@iglobalrecruit.com Urgent: Assistant Director Trainee, HLA (Greater Los Angeles Area) - Fulltime position Position Summary and Key Responsibilities The Assistant Director Trainee will be responsible for the clinical research and development in transplant immunology and to support the clinical laboratory services under the direction of the laboratory director so that high quality and state-of-the-art laboratory testing and services are achieved. Responsibilities will include:Clinical Research and Development: Create projects, design experiments, write protocols for IRB approval and manuscripts for publication, and validate new clinical testing techniques as well as Clinical Laboratory Business: Provide advice to transplant physicians, unrelated donor search coordinators, and other clinicians; review the results of clinical testing in the absence of the lab director and supervisor; investigate result discrepancies between our reports and NMDP records. Desired Skills & Experience • Minimum Education: Doctoral Degree • Req. Certification/Licensure: Certificate from related professional societies and CA licensure *********************************************************************** IP Legal Secretary/ Paralegal - San Rafael, CA For the opportunity below, please send resume to wd_darshana@hotmail.com. Other opportunities are posted in JOBS category at www.darshanavnadkarni.wordpress.com. There is an immediate opening for IP Legal Secretary/ Paralegal by a reputed bay area law firm. Requirements : Strong docket filing experience; Thorough knowledge of patent & trademark prosecution process; Experience with Electronic Filing with USPTO and Pair; Ability to type at least 60 words per minute; Knowledge of time slips program to facilitate accounting & billing functions; Experience preparing time reports, expense reports, client bills & conflict checking forms; & Familiarity with legal terminology. Absolutely required, 5+ years experience with patents and dockets; 5+ years experience working as legal secretary. Responsibilities: Provide secretarial & administrative support; Assist with preparation & filing with USPTO and of foreign patent & trademark applications; Generate transmittals & formal USPTO documents; Handle foreign patent & trademark prosecution matters including PCT & foreign prosecution forms; Monitor patent prosecution docket; Prepare & file maintenance fees, assignments, missing parts & IDSs; Proofread & redline work for accuracy of copy, format, grammar, punctuation, and syntax; Type & edit computer system legal & other documents (including memoranda, bills, timesheets & project work) from handwritten or typed materials; Copy, distribute, send by courier or express service, File & otherwise handle completed work; Receive, screen & transmit telephone calls, conference calls & messages; Handle incoming & outgoing mail; Set up & maintain files. Should work independently, take initiative, set priorities & see projects through completion; Work in a team setting.

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******************************************************************** Apply on company website Senior Project Manager Genentech- San Francisco Bay Area Job Description Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our Vacaville, California facility: Senior Project Manager Responsibilities: The Senior Project Manager will provide leadership and project management for site and corporate driven projects such as tech transfers, facility modifications and new construction. Projects are primarily large and/or cross-functional in nature. He or she will manage all elements for the planning and design phases including project initiation and conceptual, basic and detailed design. The Senior Project Manager will manage all elements for the construction phase including bid reviews, contract negotiation and management, purchase order processing and tracking, contractor on-boarding, construction supervision, change order negotiation and tracking, build review and punch-list management, turnover package review and construction phase closure. He or she will be responsible to develop, improve and drive streamlined project execution, documentation, information management and business processes in the department. Requirements: The candidate must have a Bachelor’s degree in Engineering, Biological Sciences, Physical Sciences, or other relevant technical field as well as a minimum of eight years of relevant work experience as a project manager, preferably for a biotech or pharmaceutical plant. He or she will have experience within a regulated environment and project management in chemical/petroleum industry or architectural and engineering firm. Preferred areas of knowledge include biopharmaceutical and pharmaceutical process and facility design, general knowledge of applicable building codes and related regulations and FDA and EMA cGMP requirements. Project management training or certifications are recommended. The candidate should also be proficient in Microsoft Word, Excel, Project and PowerPoint. Visio is a plus. Passionate About Our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life. Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. To apply for this job, visit http://www.gene.com/careers/find-a-job/apply?job_&src=JB-12480 Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. We are an equal opportunity employer. Company Description At Genentech, we are passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Additional Information Posted:July 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science

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Industries:Biotechnology Job ID:6416782 ****************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=6603361&trk=jobs_seeking_view_job&goback=%2Evjs_6749958_*2_*2_*2_false_*2_*2%2Evjs_6416782_*2_*2_*2_false_*2_*2%2Evjs_6697531_*2_*2_*2_false_*2_*2 Senior Project Manager Counterpoint Systems - Greater Los Angeles Area Job Description Counterpoint Systems seeks a qualified Senior Project Manager to manage multiple intermediate-to-large scale software implementation projects through completion, involving extensive, direct day-to-day client engagement, coordination and scheduling of people and other resources; and, closely tracking and reporting project progress against client and Counterpoint Systems expectations and delivery schedules. This is a highly visible role requiring proactive collaboration and communication across external stakeholders, and internal development, sales, marketing, client services and other teams. The Senior Project Manager must balance being the client voice/advocate along with the business needs of the Company. The incumbent reports to the Manager of US Client Services. Responsibilities

Coordinate and manage software implementation project planning for multiple enterprise software projects from pre-implementation planning through successful completion

Proactively evaluate, recommend and track resource needs and metrics Manage the release schedules including all tasks and who owns them with due dates Develop and closely manage project time lines and communicate updates to internal

and external resources as appropriate Proactively collaborate and communicate with internal functional and project related

resources and external stakeholders to provide project management and direction on software analysis, design, development, testing and deployment

Closely monitor project status, troubleshoot and resolve obstacles, ensuring timely project progress

Provide a clear focus for the communication of milestones and technical schedules through pre-implementation, implementation and post-implementation execution

Provide periodic status to senior management regarding active projects including escalation of concerns, issues and obstacles

Actively manage client expectations and keep them in line with realistic commitments as received from Applications Development team and other resources

Other duties as directed or required Desired Skills & Experience Requirements

5+ years’ experience in project management for multiple, simultaneous, intermediate-to-large scale software implementations involving integration with clients’ existing technology environment

Ownership and accountability of accurate and timely project planning, management, coordination, tracking and reporting using major software project management tools (i.e. MS Project)

Proactively manage changes in project scope, identify potential risks and barriers to success, devise contingency plans and implement optimal client and Counterpoint Systems business solutions; manage to aggressive deadlines

Proven creative, innovative, analytical and critical thinking to strategies, practices and problem-resolution; ability to anticipate and address unforeseen issues; strong attention to detail

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Experience with business analyst role in full software project lifecycle -- documenting, use cases, designs, test cases, and helping with implementation preparation activities

Exemplary client-facing, technical and business service and support skills, with proven ability to effectively develop and maintain successful colleague, client and strategic partner relationships

Strong verbal and written communication skills; proven capabilities interacting professionally with all levels of an organization – i.e. internal and external executives, technical and non-technical teams, subject matter experts, and end-users

Advanced computer skills and working knowledge of MS Project, Visio, Word, Excel, PPT, Outlook

High level of integrity and ownership for work products and timely deliverables; results oriented

Proactive, enthusiastic, positive, can-do attitude; able to work independently and within a team

Highly reliable and dedicated work ethic – consistent attendance and punctuality are critical

Willingness to pitch in anywhere and wherever, as business needs demand Self-motivated; self-directed; highly-organized BA/BS degree required

Highly Preferred Certification in Project Management (PMP) Experience working with on-demand CRM systems Working knowledge of the music publishing, media/entertainment, and/or brand

licensing industries Experience with processing royalties and/or intellectual property licensing industry

experience What We Offer

A great place to work Opportunity to actively participate on a wide range of projects for multinational

companies solving technical and business operations problems for the music, consumer products, media/entertainment and other intellectual property licensing industries

Competitive base salary + benefits Career development opportunities A growing, dedicated team of high-performing people, passionate about technology and

delivering outstanding service and support to our clients How to Apply

Email your cover letter including salary expectations plus resume to jobs@counterp.com Please write “Senior Project Manager” in the subject line of your email

Counterpoint Systems Supports Workforce Diversity & Equal Opportunity Local candidates preferred. No relocation assistance provided. No visa sponsorship. Principals only. No Agencies. No calls please. Company Description Counterpoint Systems is the world leader in software solutions for rights management, royalty accounting and product licensing for the media & entertainment, music and consumer products and brand licensing industries. Counterpoint’s software helps its clients maximize the value of their intellectual property by providing sophisticated tools to manage rights and program finance. Counterpoint services over 500 active customers in over 25 countries. Additional Information Posted:July 26, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Information Technology

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Industries:Computer Software, Information Technology and Services Job ID:6603361 ******************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=6697531&trk=jobs_seeking_view_job&goback=%2Evjs_6749958_*2_*2_*2_false_*2_*2 Senior Project Manager Synergroup Systems- Greater Los Angeles Area Job Description Responsibilities: - Will Lead complex, high-visibility acquisition and integration projects for the Risk M&A Program Office. - Facilitate and manage pre-planning, target operating model, execution and post-conversion efforts Knowledge & Skills: • Understands financial planning, project budgeting, and expense tracking to successfully manage project budgets to completion • Working knowledge of complex technology systems implementations. • Strong proficiency in MS Project, Word, Excel, Power Point, Visio, Access, Business Objects reports • Proven experience applying process improvement best practices for large scale projects. • Experience with SOX, OCC, and other financial regulatory requirements. • Strong communicates skills. Desired Skills & Experience Senior Project Manager – Financial SFR We are currently conducting a search for our large client located in San Francisco. Requires: . • 7-10 years of Project Management/ PMO experience • 5 plus years of financial domain experience • PMI and Six Sigma certifications highly preferred M&A Experience Highly Prefered Company Description Synergroup Systems, Inc. is a Southern California based technology staffing services firm with a reputation for delivering cost effective, high quality technical consultants on a timely basis. Since our inception in 1986, Synergroup has worked with a large number of Fortune 1000 companies to meet their IT requirements in a timely manner. Headquartered in Laguna Niguel, CA; Synergroup serves clients throughout the US. Our services are offered on a strategic staffing basis across all technology platforms, operating systems and infrastructures. We have a proven track record of providing prompt, creative solutions to highly complex business challenges and deploying both onsite and offsite service models as the situation demands. In a business environment where IT budgets and delivery expectations are often moving in opposite directions, Synergroup has consistently demonstrated the ability to provide the highest level of service at the best possible price. Our methodical approach to cost effective recruiting and our strong commitment to customer satisfaction allow us to deliver a high value proposition to our clients. Our Mission

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To provide the highest level of IT staffing solutions available in the industry by becoming business partners with our clients and consultants – understanding our customers’ goals and consistently delivering timely cost effective solutions that meet and exceed their expectations. Partnering For Success From the beginning, we have always believed that the quality of our customer relationships would determine our success. We understand that every manager is judged by their ability to organize resources and to complete a job within a limited budget. More and more frequently, managers will ask us for additional flexibility in various areas including rates, conversion fees or placement fees to fit their budgetary restraints. Over the years, we believe this partnering philosophy has proven to be very effective in building the lasting relationships that have played a major role in our long-term success. We truly believe that our success can only be measured to the degree we contribute to the success of our clients. Reducing Costs/Delivering Value Since 2000, IT budgets have been under constant and consistent downward pressure. We have responded by developing unique ways of keeping our internal costs at a minimum, and passing the savings to our customers in the form of lower rates. Our model allows us to deliver the resources our clients need fast, while providing the world class quality they expect. Truly Innovative Staffing Solutions In an industry not known for innovation, we’ve made it our mission. In 2004, we developed the Homeland Onshore Model (HOM) and introduced it to the market as a viable cost effective alternative to offshore outsourcing. The results have been stellar, producing savings of up to 50% over FTE’s with similar skills. The model continues to drive substantial savings to our customers. Recently, we have seen a surging demand for HOM among our new and existing clients. Additional Information Posted:August 3, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management Industries:Banking Compensation:$75/hr Job ID:6697531 ********************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=6749958&trk=eml-anet_dig-b_premjb-ttl-cn&fromEmail=&ut=2eRRgpYrUBXBQ1 Senior Project Manager SThree plc- San Francisco Bay Area Job Description Senior Project Manager A biopharmaceutical company in the San Francisco bay area is looking for a contract Senior Project Manager to join their team. Although this is a contract position, there is a good chance that the contractor will be offered an permanent position if it is a good fit. The Senior Project Manager will be working a Phase II oncology study. Desired Skills & Experience Senior Project Manager Requirements:

5+ years of experience as a Project Manager in the Biotechnology or Pharmaceutical industry

Supported a program in Clinical Development, Phase I - Phase III Excellent facilitation skills working closely with cross-functional teams and external

partners Excellent written and verbal communication skills Ability to take high level meeting minutes, determine action items, risks, and agendas

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Oncology experience is a plus Diagnostics is a plus MS Project is a plus

Education: Healthcare education or a Masters with a lab background is desired but not required.

This is an urgent position and we are looking to fill this role immediately. Please reply to this job posting if you are interested . Company Description The SThree group is a world leader in the recruitment industry, boasting a unique portfolio of renowned recruitment brands and job boards. We achieved a listing on the FTSE London Stock Exchange through our successful focus on professionals in high-end, specialist roles. Our brands place professionals across tightly defined sectors. These include: Banking & Finance, Energy & Natural Resources, Pharma & Biotech and Healthcare. We were established in 1986. Back then we were a small start-up company. Now we employ over 2300 people. Our operations span five continents, 18 countries, and 40 cities. And we’re not finished yet. Our plans for the future are big, bold and most importantly, achievable. We’re opening further offices in the countries where we currently operate. And we’re expanding into new territories and niche sectors. Ambition like this needs serious investment. So we're looking to invest in SThree by employing exceptional people to drive the business forward. Whether it’s in Sales, IT, Marketing, Finance, Legal, HR or Learning & Development. We want the most talented individuals to work for us in every department. You could be a graduate or a professional with previous experience. If you're looking for a job in sales or a career in recruitment, we'd love to hear from you. We also have outstanding opportunities for graduates and professionals in our Support Services functions. Additional Information Posted:August 7, 2013 Type:Contract Experience:Mid-Senior level Functions:Project Management Industries:Biotechnology, Pharmaceuticals Job ID:6749958 ********************************************************************** Jobs Listed by BIO Jobs: The Talent Hub for Biotech is a new job listing service of BIO Do your own search at http://jobs.bio.org/home/index.cfm?site_id=15768 I’ve listed the 93 jobs listed today for California. Find details at the url shown above. Position Location Posted Project Management Consultant Integrated Project Management

08/06/2013 QA Director

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AmpliPhi Biosciences San Diego, California, United States 08/06/2013 Biologist - Edwards Air Force Base, California CH2M HILL

Lancaster, California, United States 08/05/2013 Director Assay Development HTS (1534_0010763676-01-1) Novartis Institute For Functional Genomics, Inc.

San Diego, California, United States 08/04/2013 Postdoctoral fellow University of California San Francisco

San Francisco, California, United States 08/04/2013 QC Senior Scientist, Microbiology Genentech

South San Francisco, California, United States 07/25/2013 Terrestrial Biologist Cardno ENTRIX

Sacramento, California, United States 07/16/2013 Senior QC Pharmaceutical Specialist-Pharmaceutical Specialist Method Transfer Genentech

South San Francisco, California, United States 07/11/2013 QC Pharmaceutical Specialist II-Contract Labs/ExQC

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Genentech South San Francisco, California, United States 07/11/2013 Calibration Technician IV - Los Angeles, CA area Tektronix

Los Angeles, California, United States 07/10/2013 Calibration Technician III - Los Angeles, CA area Tektronix

Los Angeles, California, United States 07/10/2013 Postdoctoral Appointee- Biomass Science and Conversion Chemist Sandia National Laboratories

Emeryville, California, United States 07/03/2013 Pipette Calibration Technician I Pharmaceutical Calibrations and Instrumentation, LLC

San Francisco, California 06/11/2013 Jobs from the Web Research Assistant II, Biology California Institute for Biomedical Research La Jolla, CA, US 08/06/2013 Product Innovation - Microbiologist The Clorox Company Pleasanton, CA, US 08/02/2013

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Technician, Facilities Calibration - Campbell Allergan, Inc. Campbell, CA, US 07/29/2013 Clinical Lab Scientist III Sharp Memorial Hospital San Diego, CA, US 08/02/2013 Research Associate I City Of Hope Duarte, CA, US 08/02/2013 Biologist - Edwards Air Force Base, California CH2M HILL Lancaster, CA, US 08/06/2013 Mgr I Quality Lab Baxter Los Angeles, CA, US 08/04/2013 Chemist -Industrial industry Kelly Services Norwalk, CA, US 08/01/2013 Business Unit Marketing Manager (D13-044) Bio-Rad Chino, CA, US 08/02/2013 Director Quality Baxter Thousand Oaks, CA, US

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08/06/2013 Biologist Tetra Tech Santa Barbara, CA, US 08/02/2013 Planning & Controlling Manager heraeus incorporated Los Angeles, CA, US 08/01/2013

- See more at: http://jobs.bio.org/jobseeker/search/results/?site_id=15768&vnet=0&t735=120&filter=California&search=Filter+Results#sthash.J7lELEW7.dpuf

CA CLS (Clinical Laboratory Scientist) All Specialties... Staff Icons Los Angeles, CA, US 07/30/2013 Agricultural Biologist I San Joaquin County Stockton, CA, US 07/30/2013 Mammographers, PET/CT Tech & Sonographers - New Outpatient Ctr RadNet Management Inc. Rancho Cucamonga, CA, US 07/16/2013 Clinical Laboratory Scientist I Quest Diagnostics Inc. Cypress, CA, US 07/20/2013 Terrestrial Biologist Cardno TBE Concord, CA, US 07/12/2013

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CLS - California state licensed Clinical Laboratory Scientists Staff Icons Sacramento, CA, US 08/07/2013 Terrestrial Biologist AECOM Bakersfield, CA, US 07/27/2013 Manager / Senior Manager, Business Development, Genentech Partnering Roche San Francisco, CA, US 07/09/2013 Protein Characterization Scientist Eurofins Scientific South San Francisco, CA, US 08/04/2013 Manager / Senior Manager, Business Development, Genentech Partnering Genentech South San Francisco, CA, US 07/30/2013 Wildlife Biologist Santa Ana, CA, US 07/28/2013 Lead Biologist Pangea Biological (Pangea) Encinitas, CA, US 08/01/2013 Associate Biologist Pangea Biological (Pangea)

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Encinitas, CA, US 07/30/2013 Immunology Clinical Laboratory Scientist, CLS - Clinical Laborat - CyberCoders (Anaheim, CA) Long Beach, CA, US 08/03/2013 Clinical Laboratory Scientist Job - (alisoviejo, CA) Irvine, CA, US 07/25/2013 Clinical Laboratory Scientist - Genetics San Diego, CA, US 07/24/2013 Biomedical Engineers (California) Elite Biomedical Concord, CA, US 07/31/2013 QA Microbiologist Kelly Services Los Angeles, CA, US 08/02/2013 Computational Biologist âÂÂ" Human Genetics, Immunology, Tissue Growth and Repair - Roche (San San Francisco, CA, US 07/24/2013 Computational Biologist - Roche (San Francisco, CA) San Francisco, CA, US 07/24/2013

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Product Director, U.S. Breast Marketing Genomic Health, Inc. Redwood City, CA, US 08/07/2013

Hybridoma & Immuno-Assay Scientist PWR4255 La Jolla CA 6 mos contract A10 Clinical Solutions, Inc. San Diego, CA, US 08/06/2013 Biomedical Electronics Technician Requisition Number: 3831 Oconnor Hospital San Jose, CA, US 07/25/2013 Executive - Clarient, Strategic Development Services GE Aliso Viejo, CA, US 08/04/2013 Clinical Laboratory Technologist, Correctional Facility State of California San Luis Obispo, CA, US 08/01/2013

- See more at: http://jobs.bio.org/c/search_results.cfm?vnet=0&t735=120&keywords=California&site%5Fid=15768&str=26#sthash.Kx0HH51p.dpuf

Protein Characterization Scientist Eurofins Lancaster Laboratories South San Francisco, CA, US 07/29/2013 Research Scientist DuPont Hayward, CA, US 07/29/2013

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Scientific Liaison, Sr. Scientist BD (Becton, Dickinson and Company) San Diego, CA, US 08/07/2013 SCIENTIST Job Johnson & Johnson Family of Companies San Diego, CA, US 08/07/2013 Research Associate Scientist Hired by Matrix, Inc. San Diego, CA, US 08/07/2013 Senior Natural Resources Biologist The Johnson Group, Inc Irvine, CA, US 07/18/2013 Sr. Scientist/Scientist - Electrophysiologist Roche San Francisco, CA, US 08/07/2013 Scientist/Sr. Scientist, Development Roche San Francisco, CA, US 08/05/2013 Scientist Roche San Francisco, CA, US 07/30/2013 Scientist - Electrophysiologist

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Roche San Francisco, CA, US 07/12/2013 Associate Scientist Roche San Francisco, CA, US 08/06/2013 Product Innovation - Microbiologist International Producer of Food and Chemical Consumer Products Pleasanton, CA, US 08/06/2013 Genomic Technologies Manager Prometheus Healthcare San Francisco, CA, US 07/23/2013 Scientist/Sr. Scientist, Development Genentech South San Francisco, CA, US 08/04/2013 Sr. Scientist/Scientist - Electrophysiologist Genentech South San Francisco, CA, US 07/30/2013 Scientist Genentech South San Francisco, CA, US 07/30/2013 Associate Scientist Genentech South San Francisco, CA, US 07/30/2013

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Scientist - Electrophysiologist Genentech South San Francisco, CA, US 07/12/2013 Microbiologist Public Health Foundation Enterprises Richmond, CA, US 07/26/2013 Regulatory Laboratory Microbiologist Public Health Foundation Enterprises Richmond, CA, US 07/12/2013 Wildlife Biologist / Botanist - Brea, California Burns & McDonnell Brea, CA, US 08/05/2013 Biologist " Wetland Delineations Sequence San Jose, CA, US 07/22/2013 Senior Biologist - Wetland Delineations " CEQA / NEPA Sequence San Jose, CA, US 07/16/2013 Laboratory Associate III Fisher Scientific San Fernando, CA, US 07/20/2013 #67468 Molecular Neuroendocrinology Lab Manager University of California - San Diego

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San Diego, CA, US 08/04/2013

- See more at: http://jobs.bio.org/c/search_results.cfm?vnet=0&keywords=California&str=51&site%5Fid=15768&t735=120#sthash.000sMGs5.dpuf

Nuclear Medicine Technologist (Floater) RadNet CA, US 08/07/2013 Sr Technician, Quality Control (Calibration) CareFusion San Diego, CA, US 08/01/2013 Senior Biologist Redhorse Corporation Barstow, CA, US 08/06/2013 Senior Biologist - Regional Manager " CEQA / NEPA - Environmental Sequence Sacramento, CA, US 07/16/2013 CBG Associate II City of Hope Duarte, CA, US 08/07/2013 Biomedical Technician II - Los Angeles, CA GE Los Angeles, CA, US 08/07/2013 Technical Application Specialist Siemens

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Los Angeles, CA, US 08/04/2013 Research Associate III - Molecular Biology Fisher Scientific Los Angeles, CA, US 07/13/2013 Senior QC Associate Genentech Vacaville, CA, US 08/02/2013 WWCS PROFESSIONAL-CSE Abbott Santa Clara, CA, US 07/26/2013 Computational Biologist GE Aliso Viejo, CA, US 08/07/2013 Molecular FISH Clinical Laboratory Scientist GE Aliso Viejo, CA, US 08/07/2013 Clinical Laboratory Scientist - Flow Cytometry GE Aliso Viejo, CA, US 08/06/2013 Senior Qc Pharmaceutical Specialist-Pharmaceutical Specialist Method Transfer Roche Oceanside, CA, US 07/28/2013

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Clinical Laboratory Scientist - Cytogenetics GE Aliso Viejo, CA, US 08/06/2013 Clinical Laboratory Scientist GE Aliso Viejo, CA, US 07/24/2013 Scientist - Assay Development All Source Technical, Inc. Palo Alto, CA, US 07/13/2013 Biomedical Technician II Providence Health & Services Mission Hills, CA, US 08/07/2013 Positron Emission Tomography / Computed Tomography Technologist (PET/CT) RadNet Rancho Cucamonga, CA, US 07/12/2013 Trait Geneticist - Woodland, CA Monsanto Woodland, CA, US 07/30/2013 Research Associate/Sr. Research Associate (Monogram Biosciences) Laboratory Corporation of America South San Francisco, CA, US 07/31/2013 Postdoctoral Researcher - Bioinformatics Ventana South San Francisco, CA, US

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07/21/2013 Senior On-Call Biologist ICF International Santa Barbara, CA, US 07/08/2013 Senior Qc Pharmaceutical Specialist-Pharmaceutical Specialist Method Transfer Genentech Oceanside, CA, US 07/28/2013 Molecular Pathologist Novartis Pharmaceuticals Carlsbad, CA, US 08/06/2013 - See more at: http://jobs.bio.org/c/search_results.cfm?keywords=California&str=76&vnet=0&site%5Fid=15768&t735=120#sthash.LsEk23GT.dpuf ****************************************************************************** http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=263506611&gid=4700652&trk=eml-anet_dig-b_nd-pst_ttle-cn&fromEmail=&ut=1XgNDKh3UEURQ1 Posted by Connie Hampton, Recruiter | Scientific & Executive Search Services| For Employers and Employees in the BioWorld Possible searches/jobs I have two possible searches in the Bay Area One for a biostatistician One for a process development engineer (solid dosage) Please do let me know if you know of anyone for either of these! ******************************************************************** *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. *****************************************************************

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Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and

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other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't

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keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her

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background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************* Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites

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There’s a new biotech job site on the BIO website entitled Bio Jobs: The Talent Hub for Biotech at http://jobs.bio.org. You can search for open positions via various parameters. Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/

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Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************