9/14/2014 1

Jobs That Crossed My Desk Through Sept. 14, 2014

Complimentary Service of Audreysnetwork.com Sept. 14, 2014

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.

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Jobs That Crossed My Desk Through Sept. 14, 2014 ************************************************************************

https://jobs.smartbrief.com/action/listing?listingid=3F4B386E-E9C5-4DE9-B8A5-78F7524DF388&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-

199b99dc80c0&utm_source=brief

Date Posted:

8/25/14 Location:

San Diego , CA Years Experience:

2-5 Job Contact Phone:

858-617-3201

This Job appears in FDLI SmartBrief

Senior Counsel, Regulatory (FDA) CareFusion

Job Description Life-changers work here

CareFusion Life-changers find innovative ways to improve our customers' ability to provide healthcare to their patients. One way is our search for bold and inspired employees across the globe. Are you ready to

change lives? Join our 15,000 employees to help clinicians solve some of healthcare's most critical

challenges. Job Title: Senior Counsel, Regulatory

CareFusion Business Description

Regulatory (Attorney) is responsible for providing legal-FDA regulatory advice to legal, QRA, medical affairs, and business staff concerning Federal and state FDA regulatory actions and issues - both

proactively and reactively. Also responsible for review and advice pertaining to Company's response to alleged regulatory actions and violations. Researches FDA, FTC, DEA, DOJ, CBP, and State BOP

regulations, case law and statutes pertaining to regulatory agencies and the administrative process.

Supports business processes concerning specific legal-FDA regulatory matters and issues.

Accountabilities

9/14/2014 2

Provide assistance with regards to medical device and pharmaceutical FDA regulatory compliance.

Identify, recommend and implement where possible, corrective actions for regulatory and other related processes.

Review promotional information and product literature to ensure FDA and FTC regulatory compliance. Review governmental rulings to determine changes and probable effects on facility activities.

Correspond with the FDA, other regulatory agencies, customers, suppliers, and division personnel as needed both orally and in writing to address regulatory inquires, problems, or requests.

Report to VP, Associate General Counsel, Legal Regulatory; support department and practice area initiatives.

Perform duties in accordance with established company procedures and policies; perform other duties as

assigned.

What is expected of you for success in your role

A licensed attorney and graduate from an accredited law school with a strong academic record Demonstrates understanding of legal ramifications associated with actions by CareFusion and whether

specific matters/issues may result in potential violations and/or negative legal-regulatory impact Researches and assesses regulations, case law and statutes pertaining to regulatory agencies and the

administrative process

Provides basic advice and counsel to businesses concerning specific legal-FDA regulatory matters and issues

Reviews and/or crafts basic administrative responses to agency allegations under supervision at a higher level

Works with outside law firm(s) to help further CareFusion initiatives that are contingent upon legal-regulatory requirements

Qualifications

Graduate of an accredited US law school

2-4 years’ experience in FDA regulatory law Employee of law firm with Regulatory experience

Undergraduate degree in the physical sciences preferred

************************************************************************ Jobs That Crossed My Desk Through Sept. 7, 2014

***************************************************************************

Angel Romero

Global Recruiters of West Palm Beach 561-422-5150

Regional Sales Director Asia Pacific/International- CA- # 1535

A Global healthcare diagnostics company that offers specialized molecular diagnostics and EIA diagnostics laboratory testing products to hospitals, commercial laboratories, physicians and public health agencies to

assist with the diagnosis, treatment and management of immunology, serology and infectious diseases seeks a Regional Sales Director. Currently, we seek a Regional Sales Director for the Asia Pacific/

International Region based out of California HQs. The Regional Sales Director is responsible for managing

the assigned international region, and the distributor network to maintain and gain incremental business for new and existing products. This position will require moderate to heavy international travel and

supports applicable regulations including ISO, Local, State, and/or Federal requirements.

Key Duties, Activities and Responsibilities: · Directs the implementation and communication of all segment and product sales programs,

strategies and tactics in the assigned sales region. Identifies new sales opportunities through in-depth market and customer understanding.

· Leverages sales opportunities by prioritizing the implementation of sales initiatives. Tracks

performance and reports results to supervisor. · Collaborate with distributors to develop new business and/or to expand existing businesses

within the assigned international region.

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· Provide leadership to the distributors in the assigned international region to drive consistent

and quantifiable results through the distributors managing discipline. · Direct the implementation and communication of all segment and product sales/marketing

programs, strategies and tactics in the assigned region. · Establish direct relationships with local country opinion leaders and strategic customers in the

diagnostics, especially infectious disease arena communities in the assigned international region. Identify, select, and develop new distributors.

· Develop short and long term business plans to drive sustainable growth across all segments within the European region.

· Establishes appropriate territory assignments to effectively meet customers’ requirements and

the needs of the business. · Sets sales objectives for the sales team/distributor in his or her assigned international region

including territory quotas, performance criteria, and professional development initiatives. · Work with assigned field sales team/distributor as coach, manager and leader to maximize

customer satisfaction, employee satisfaction and the achievement of business goals. · Prepare regular analysis of sales and product line trends in assigned region.

· Keep sales team, senior staff and other employees informed of key customer activities. · Reports regional sales results on weekly and monthly basis to supervisor.

· Tracks sales/distributor performance to plan and reports results to supervisor.

· Prepares monthly sales forecasts. · Report competitive intelligence to senior staff on an ad hoc basis.

· Achieve sales goals by managing/mentoring distributor network to execute a market penetration strategy to all market segments including large hospitals and commercial laboratories,

national account customers, state/public health agencies. · Sets sales objectives for the distributor including country quotas, product support performance

criteria, and technical expertise development initiatives. · Negotiate pricing agreements that balance the needs of the organization with the needs of the

distributor.

· Develop new market in the region by identifying, selecting, and establishing new distributors in the segment.

· Establish effective business relationships with local countries opinion leader and strategic institutions such that they may serve as referral and/or consultative roles on behalf of the

Company. · Assist distributor to increase their technical expertise by providing technical demonstrations/

presentations to their key customers. · Monitor, analyze and recommend response options to strategies and tactics of competitors that

serve to threaten current and future sales of the Company.

· Investigate and communicate market development and product development opportunities as indicated by customers in the market place. Utilize proper channels and systems for submitting

such information. · Manage the assessment of current and future large buyer needs and identify opportunities to

expand testing menu and services to meet these needs. · Provide input regarding identification and selection of promotional tools for the Company. Such

items include trade shows to attend, conferences, brochures, catalogs, direct mail campaigns, etc. · Prepares quarterly sales forecasts.

· Prepare regular analysis of sales and product line trends.

· Attend local country or international trade shows as required by the Company. · Actively participate in meetings, training sessions and other sales/marketing planning sessions.

· Control selling/marketing expenses.

Work Experience, Skills and Education Required: o Bachelor of Science degree or equivalent. Advance degree such as MBA, Master, PhD or

equivalent is preferred. o Must have an understanding and experience working in the Asian Pacific Market.

o Minimum 10 years related experience and/or training; or equivalent combination of

education and experience in diagnostics IVD sales and experience in doing business in the Asia/Pacific/International region.

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o Works on assignments that are complex in nature where considerable judgment and

initiative are required in resolving problems and making recommendations. o Ensure sales quota and business schedules are met.

o Regularly interacts with senior management on matters concerning several functional areas, divisions, and/or customers.

o Must possess excellent inter-personal skills and communication. o Demonstrated strategic thinking skills and ability to implement strategic plans.

o Experience negotiating contracts with hospitals, health systems, commercial laboratories and distributors.

o Experience in dealing with senior level healthcare executives.

o Demonstrated ability to motivate and manage sales organizations to achieve plan. o Strong written communication and public speaking skills.

o Very effective people skills and negotiating ability. o Excellent team player reputation.

o Enthusiastic attitude. o Technically sound understanding of immunology, microbiology & molecular diagnostics.

o Sales leader. o Mature, hardworking, flexible, problem solver, decision maker with integrity and a strong

standards of morals.

o Self-motivated. o Strong organizational and detail implementation skills.

o Computer literate with customer contact management software and Microsoft Office _________________________________________________________________________________

Associate Director, Marketing (Core Products/Software) #1666 Our Client is a global diagnostics leader in diagnosing infectious diseases and screening blood at major

healthcare institutions worldwide. The position is based out of the company’s California headquarters. This roll will provide marketing leadership for the Core Products, including Software, through high level

product commercial support, new product development and by contributing to the long term strategy of

developing new products to address the blood and plasma screening markets.

Key Duties, Activities and Responsibilities: · Gather and use Voice of the Customer to understand and prioritize specific needs and interests

to define, create and commercialize market-leading software products for blood screening and testing.

· Facilitate the process to gather, document and finalize the business/customer requirements for software development.

· Serves as the leader and is responsible for clearly setting and communicating specific

functionality of new middleware systems through application development by actively involving stakeholders and understanding and prioritizing their specific needs and interest.

· Owns business case and ROI analysis for prioritization of opportunities and develops business cases for management review and implementation of new product development for software

systems. · Develop and implement a consistent software brand identity across blood and screening

products. · Demonstrate middleware and LIS market expertise by providing fact based analysis on

competitive trends to drive product development strategy and improve sales effectiveness.

· Contribute to establishing, influencing and maintain a global network including key opinion leaders and policy makers in the blood and plasma screening market, middleware, and donor

information management. · Work closely with Companies business partners in order to meet software product development

milestones and successfully new product launches. · Create tactical plans to support, protect and expand our global market share.

· Develop programs and materials for us by account managers, and commercial marketing associates for driving the core business sale.

Work Experience, Skills and Education Required: · BS in life sciences, computer science or marketing, MBA preferred; Healthcare/Diagnostics

experience with MBA highly desirable.

9/14/2014 5

· Minimum of 10 years pharmaceuticals/medical devices/diagnostics industry experience with 4-7

years marketing or marketing-related experience preferred. · Product launch, commercial support and product development experience required with a

specific emphasis on instrument software and middleware systems. · Comprehensive understanding of the blood screening markets, use of company products, legal

and regulatory issues impacting product marketing · Established record getting diagnostic products to market through innovative partnerships and

access programs, · Experience with software pricing strategies and delivery

· Ability to take comprehensive scientific data and convert into useful marketing and sales tools

· Understand global registration requirements in the blood and plasma screening markets · Leadership skills, including the ability to solve problems

· Persuasive written and verbal communication skills. · Team player able to collaborate with cross-fictional groups

_________________________________________________________________________________ Senior Director of Global Marketing –CA-#1687

A Global healthcare diagnostics company that offers specialized molecular diagnostics and EIA diagnostics laboratory testing products to hospitals, commercial laboratories, physicians and public health agencies to

assist with the diagnosis, treatment and management of immunology, serology and infectious diseases

seeks a Senior Director of Global Marketing. The position reports directly to the President of the company.

Key Duties, Activities and Responsibilities: Plans and directs commercialization of Diagnostics Products including policies, objectives, and initiatives.

Supports applicable regulations including ISO, Local, State, and/or Federal requirements. This role provides overall direction to the company’s biggest growth strategy.

· Responsible for the development and execution of both annual and quarterly global marketing plans to achieve or exceed the business, financial and strategic goals for the company.

· Direct worldwide marketing activities, including marketing, product portfolio planning, strategic

partner strategy and development, product management, marketing communications, market research/assessment, business development and strategic planning, and tradeshow management

related to the company.. · Act as marketing and overall contract management liaison with their strategic partners

· Lead Product Line Development Team · Member of Portfolio Working Team

· Ensure global compliance with product positioning & strategy; including but not limited to account targeting, special projects management, distributor selection, and government sales & projects

· Collaborate with U.S. and International Sales leadership to create annual and quarterly tactical sales

plans · Participates in the development of overall company plans and strategies that enable sustained

growth in the healthcare arena. · Manages departmental budgets and expenses within stated guidelines.

· Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of

the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related

programs and assist in solving safety and health problems. Violations of safety directives and

procedures will be handled in accordance with the established Company disciplinary process. · Perform other duties as assigned.

· Manages 8-10 direct reports. · Is responsible for the overall direction, coordination, and evaluation of direct reports.

· Carries out supervisor responsibilities in accordance with the organization’s policies and applicable laws.

· Responsibilities include interviewing, hiring and training employees; assigning sales plans, directing work; appraising performance; rewarding and disciplining employees up to and including firing;

addressing complaints and resolving problems.

Work Experience, Skills and Education Required:

· B.S. or B.A. Degree-MBA preferred.

9/14/2014 6

· Minimum of 7–10 years of senior marketing and sales experience in the diagnostics industry,

including 3+ years in molecular diagnostics. · Demonstrated ability to gather and analyze market and competitive data and set strategic

direction. · Significant experience interacting with senior level healthcare executives and in developing

successful relationships with strategic customers and business partners. · Knowledge of the infectious disease products and services market place.

· Experience with successful new product launches, market segmentation, and branding. · Knowledge of scientific products required.

· Able to handle multiple projects in a dynamic, high velocity work environment.

· Self-motivated and able to work independently. · Proficient working knowledge of MS Word, Excel, PowerPoint and Access.

· Able to travel extensively. · Able to handle multiple projects in a dynamic, high velocity

· Excellent public speaking and written communication skills. · Demonstrated ability to discuss new product concepts and industry trends with Ph.D. and MD

level individuals and groups · Strong financial and analytical skills required; strong attention to detail

· Relies on experience and judgment to plan and accomplish goals.

_________________________________________________________________________________

Molecular Diagnostics Senior Product Marketing Opportunity in the Fast - Growing Infectious Diseases Arena - CA – #1698

Our client is a global pharmaceutical, medical device and diagnostics manufacturer that develops and produces therapies and diagnostics/medical device products in three healthcare divisions: Bioscience

therapies made from human plasma; Hospital products and pharmacy IV solutions; and Diagnostic tools and instrument/reagents systems for laboratory professionals. Their diagnostics division, a global leader

in diagnosing infectious diseases and screening blood at major healthcare institutions worldwide, is

seeking a Product Marketing Manager/Sr. Manager. The position is based out of the company’s California headquarters and will be responsible for both the global development and regional execution of marketing

programs in the Americas. (US, Canada & Latin America) We are searching for a Product Marketing Manager/Sr. Manager to provide marketing leadership for our

clients’ infectious diseases and blood screening portfolio. The incumbent will be responsible for their proprietary line of pipetting systems and secondarily responsible for their instrument system. This role

will be responsible for both upstream and downstream marketing activities for the reagent solutions portfolio.

Key Duties, Activities and Responsibilities:

Assess customer needs, competitive risks, and long-term marketing potential of products. Collects voice of customer feedback for the development of new products and to enhance current

on-market products. Represent global marketing for product development core team activities.

Provide regular product updates throughout the organization to support commercial efforts. Ensures product messaging is market appropriate and positions the companies’ products effectively

against competition. Develop and maintain sales and scientific materials to support the sales and promotion of their

proprietary reagent solutions.

Attend and lead commercially driven customer meetings and symposia to drive product sales. Ensure the product pipeline corresponds with current market needs.

Develop business cases to support new product development activities. Clearly define project scopes, deliverables and timelines through standard project management

means. Work with regional commercial marketing teams to identify tools to enhance sales process.

Will work with the instrument system product manager to develop sales tools to support the commercial regions.

Will work with the marketing communications team to develop materials which support the brand

identity. Will work closely with senior members of global marketing team to deliver overall product portfolio

deliverables.

9/14/2014 7

Work with overall product management team to identify and align dependencies to ensure a

complete solution is provided to customers. Produce and distribute regular and ad-hoc progress/status reports and management dashboard

Work Experience, Skills and Education Required: BS in life science or marketing; MBA highly preferred.

2-5 years’ experience in sales and marketing organization in diagnostics/medical devices, with emphasis on product development and project management. 5-7 years’ experience for Sr. Product

Marketing Manager level Prefer experience with both upstream and downstream marketing.

Strong written, verbal, and interpersonal communication skills.

Ability to work independently, as well as in close collaboration is required. Working knowledge in worldwide IVD regulatory processes and clinical evaluations highly desired.

_________________________________________________________________________________

QA/Scientific Affairs – Regulatory Affairs Specialist II –#1707

A leader in commercial diagnostic reference laboratory testing, information, and services seeks a QA/Scientific Affairs – Regulatory Affairs Specialist II to provide pre-market regulatory strategy and

implementation to ensure regulatory approval objectives that support commercial initiatives for new and

modified products. They will supports applicable regulations including Local, State, Federal and/or International requirements.

Key Duties, Activities and Responsibilities:

· Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.

Prepare global regulatory applications, as well as internal regulatory file documentation. · Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA)

Applications and Supplements, EU IVDD Technical Documentation, and global product registrations.

· Communicate with regulatory agencies on pre-market submissions related activities under the direction of management.

· Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc.

· Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.

· Provide direction on submission support, international registrations, and labeling to junior department members.

Work Experience, Skills and Education Required:

· B.S. in life-science or engineering degree, and three to five years of pre-market regulatory experience in the medical device industry or equivalent (education and work experience).

· Must have knowledge of U.S, Canadian, European and other International in vitro diagnostic regulations and standards.

· Must be able to work well in a team environment with individuals from diverse functional areas, as well as independently manage work.

· Must demonstrate leadership skills in team setting.

· Should have experience working on project/product from concept to market introduction. · Must have proven analytical capabilities, solid understanding of manufacturing processes,

change control, regulatory principles and regulatory trends. · Should have experience in presentation and negotiation of technical issues with internal and

external functions including health authorities. · US-RAC required with less than five years medical device experience. Preferred with greater

than five years regulatory experience, but not required.

_________________________________________________________________________________

Associate Director, Marketing (Molecular Genotyping) – CA #1675 Our Client is a global diagnostics leader in diagnosing infectious diseases and screening blood at major

healthcare institutions worldwide. The position is based out of the company’s California headquarters and

9/14/2014 8

is responsible for the development and execution of marketing programs in the Americas. (US, Canada &

Latin America)

Key Duties, Activities and Responsibilities: This role will provide marketing leadership for the systems marketing team and also be responsible for

establishing customer facing product positioning for the entire company Molecular Genotyping product portfolio. The systems marketing team is responsible for high level product commercial support and

portfolio strategy development as it pertains to the Molecular Genotyping analytical systems and reagents products portfolio.

· Develop sales tools for use by account managers, and commercial marketing associates for driving Molecular Genotyping sales.

· Identify new product concepts and develop business cases for executive management review and approval.

· Create tactical plans to expand, support and protect our global market share. · Work closely with company’s business partners in order to meet product development

milestones and successful new product launches. · Establish self and team as product experts for Molecular Genotyping systems portfolio.

· Contribute to establishing, influencing and maintaining a global network including key opinion

leaders and policy makers in the Molecular Genotyping blood and plasma screening market. · Develop and implement a consistent brand identity across Molecular Genotyping blood and

screening products. · Utilize the Voice of the Customer for validating customer needs.

· Represent systems marketing team at global industry meetings. · Accountable for global marketing deliverables as part of product core teams.

· Responsible for global launch and rollout of Molecular Genotyping analytical systems. · Overall responsibility for Molecular Genotyping analytical and reagent systems life cycle

management.

Work Experience, Skills and Education Required: · BS in life sciences or marketing, MBA preferred; Healthcare/Diagnostics experience with MBA

highly desirable · Minimum of 10 years pharmaceuticals/medical devices/diagnostics industry experience with 4-7

years marketing or marketing-related experience preferred. · Product launch, commercial support and product development experience required.

· Experience in commercial customer facing role (sales or regional marketing)

· Comprehensive understanding of the Molecular Genotyping blood screening markets, use of company products, legal and regulatory issues impacting product marketing

· Established record getting diagnostic products to market through innovative partnerships and access programs

· Ability to take comprehensive scientific data and convert into useful marketing and sales tools · Understand global registration requirements in the Molecular Genotyping blood and plasma

screening markets · Experience presenting to executive management

· Leadership skills, including the ability to solve problems

· Persuasive written and verbal communication skills · Previous people management experience.

_________________________________________________________________________________ Software Engineer – CA #1674

Our Client is a global diagnostics leader in diagnosing infectious diseases and screening blood at major healthcare institutions worldwide. The position is based out of the company’s California headquarters and

is responsible for the development and support of in-vitro diagnostic software systems projects. Key Duties, Activities and Responsibilities:

The Software Engineer in the Systems Engineering team will develop and support in-vitro diagnostics

(IVD) systems with an emphasis on software based projects. As a development engineer in cross-functional project teams, he/she shall work as a subject matter expert in solving in-depth and cross-

9/14/2014 9

functional problems and/or technical challenges by utilizing expertise in software development, networking

and systems engineering. Major Activities:

· Contribute to development of software, from requirements through design, implementation, and validation and release to customers.

· Contribute to the architecting of software systems solutions for in-vitro diagnostics systems and interfaces to other diagnostic lab systems and LIS.

· Interact with outside partners and vendors work and progress towards developing software products, including prototype testing, defect reviews, design reviews, V&V and UAT.

· Develop system level product requirements and software/component requirement documents

using requirements management methodologies including change management. · Partner with Global Marketing to develop customer requirements; work with other internal

stakeholders to facilitate the collection of business and regulatory requirements. · Define and prepare a schedule of development tasks.

· Conduct patient safety risk management activities according to FDA and ISO regulations. · Establish product configuration management.

· Plan and perform system, integration and unit testing. · Support verification and validation activities.

· Document and present work product to project team and business stakeholders.

· Develop user instructions and training materials for the product developed.

Work Experience, Skills and Education Required: · B.S. Degree in Engineering and/or Science; advanced degree preferred

· 3+ years of relevant experience developing software based diagnostic products. · Ability to solve complex software issues and problems, for both application and networking

software. · Experience with Laboratory Information Systems (LIS) is a plus.

· Experience in database based software development.

· Experience in graphical user interface design and development. · Demonstrated software product development experience using lifecycle methodologies and

under FDA design control. · Possesses project management skills in managing priorities, delegating, and influencing others.

· Experience in a cross functional environment. · Ability to convey complex information in both written and oral form.

· Experience with external vendor relationships. · Ability to influence others, gain acceptance and build consensus.

· Excellent communication and interpersonal skills.

· Knowledge of molecular biology is a plus.

_________________________________________________________________________________ Regional Business Manager – North East - #1643

A diagnostics and life sciences company that focuses on developing technologies and products for advanced microarray diagnostics is looking for a Regional Business Manager

Key Duties, Activities and Responsibilities:

The Business Manager has responsibility for the company’s’ pharmaceutical, biotech, and CRO sales and

market development management in the assigned market territory and escalating the demand to maximize the usage of products and services. The Business Manager will develop relationships and thusly

create sales through the coordination of presentations, discovery of and participation in industry conferences, and various other sales activities. The BM is expected to reach and attain sales goals using

his/her tools and relationships available and develop high quality single and multiplex immuno-assay (PK/PD, Immunogenicity, serotyping, etc..) and biomarker data utilizing complex biological matrices (live

cells, serum, plasma, tissue, etc..). He/she will partner with the VP of Global Commercial Operations and other field personnel to drive a pharma-directed sales plan throughout the market in their assigned

region. This person will be responsible for maximizing awareness of product benefits, account penetration,

customer satisfaction and sales growth for long-term profitable results. The Pharma Business Manager is accountable to partner with and provide the technical expertise to the pharmaceutical industry & their

CROs (or vice versa) to increase utilization of the company’ technology.

9/14/2014 10

Job duties include but are not limited to:

· Represent the Company professionally, ethically, and morally at all times

· Development of a territory and account-specific sales plan · Execution of plan to meet sales goals

· Develop and continually maintain in-depth understanding of the immunogenicity market and its place in the regulatory spectrum, bioanalytics, and LBA assay customers, competitors, and

regulatory changes · Delivery of technical seminars and presentations on company products and their capabilities

· Effectively prospect to generate new leads and schedule webex and face-to-face presentations

and meetings in collaboration with the Global Commercial Operations team · Develop and maintain strong customer connections at various levels in the organization

· Manage an expense budget · Maintain a collaborative working relationship with internal, cross-functional colleagues

Work Experience, Skills and Education Required:

· Bachelor’s degree or greater in business, marketing, or related life sciences · 5+ years commercial experience with multiplexing or microarray technology directed at the

pharma and/or biotech market

· 3+ years commercial experience with a service-oriented laboratory sale · Required: Established relationships in pharma and biotech accounts, specifically in the field of

immunogenicity and bioanalytics of large molecules · Experience working in a Specialist or overlay function desirable

· Strong technical background in said function preferred · Proven team player with strong interpersonal and communication skills

· Demonstrated track record in lead generation and prospecting · Previously demonstrated success with complex sales

· Experience in a small-company environment

· Strong commercial professional with proven ability to network at all levels within the customer organizations and in the broader marketplace

· A driver with excellent time management, communication, multi-tasking and organizational skills

· Strong desire to drive business and establish long term customer relationships and loyalty · Self-motivated and self-directed individual who enjoys a challenging, relatively unstructured

and dynamic work environment · Detail and service oriented individual

· Ability to travel internationally

· Ability to travel overnight 50% or more may be required

_________________________________________________________________________________ Bio Process Specialist - CA #1663

A global life sciences and medical device manufacturer is seeking a Bio Process Specialist

Key Duties, Activities and Responsibilities: · Adhere to Company Corporate policies; local Quality Manual, Health & Safety, travel and IT

policies

· Responsible for DSP/USP development within the region. · Support current Biotech/Vaccine customers and develop new customers within the region and

other regions as required. · Develop strategies (with local management) to maximize the sales opportunities.

· To educate and advise customers of best suited company technology. To do this, the candidate must have a good knowledge of companies technologies and develop a common approach of which

product to use and where in a Biotech process. · Be a company expert in integrated Biotech/Cell Therapy processes – primary purpose to

increase number of applications that have company specified and therefore increase companies

sales.

9/14/2014 11

· Work in close relationship with the sales representatives (“account manager”) responsible for

the account(s) and local SLS team to coordinate and agree the main activities in the respective geographic sales area.

· In conjunction with Marketing, identify new Biotech/Cell therapy opportunities ( from pipeline/drug tracking information or company start up level, e.g. new CRO / CMO) Generate

sales leads and then review with sales management. · Work with Marketing to track and report progress metrics for penetration of drug and cell

therapy pipeline. · Contribute to Sales and Marketing in the planning and presentation of Biotech seminars.

· Develop expertise by regular pan regional and global communication – exchange of

experiences, applications and technology training. · Coordinate the identification and generation of necessary technical documents for internal and

customer use. · Perform and coordinate bench scale test work in conjunction with the SLS Team to demonstrate

how to get the best out of companies products. · Work closely and have regular contact with the Level 3 Sales / Technology Specialists to

facilitate technical project and/or account handover when appropriate. · To work in close relation with Applications R&D and / or the other teams to assist in the

development of companies application platforms in the various Biotech processes.

· Contribute to tactical/ strategic plans as requested by commercial. · Maintain up to date awareness of relevant technical developments.

· Experience and skills to be used anywhere in region. · Ability to plan and organize test work

· Ability to communicate both verbally and in writing · Ability to give presentations at conferences, events.

· Ability to operate as a member of a multidisciplinary team including sales, marketing, SLS etc. · Knowledge of scientific principles and practices relevant to Biotech customers and processes

· Knowledge of Industrial fermentation/cell culture, separation or process analytical technologies

is an important added value · Good interpersonal skills to motivate others

· Ethical and scientific behavior · An awareness of the cost effectiveness of individual projects and their resultant financial

implications

Work Experience, Skills and Education Required: · 2-3 years minimum relevant experience

· BA Degree (or equivalent)

· Working and traveling outside of normal business hours · 50% + travel within U.S., Canada and Latin America

· Experience in Biotech industry · MSc or Higher in Biochemistry, Chemical Engineering or Life Science Bio)/Engineering ( Bio)

_________________________________________________________________________________

Single-Use Technology Sales Specialist #1671 A phenomenal opportunity as a Single-Use Technology Sales Specialist

A Fortune 1000, materials science and engineering company with the broadest filtration, separation and

purification capabilities in the world. Our process and product enabling technologies help our customers make good products better, safer and even possible. They provide innovative products to customers in

health care, biotechnology, pharmaceutical, semiconductor, municipal, drinking water, aerospace and industrial manufacturing markets. Headquartered in the NE, with operations in every major country.

Key Duties, Activities and Responsibilities: The Sales Specialist will grow the company’s Single Use Technology business by developing existing

customers and new-buying accounts in the Mid-Atlantic region. The sales specialist ensures targets are achieved via direct sales activity with customers and by working with local account managers. We offer

competitive compensation, a comprehensive array of benefits, and the opportunity to work with a dynamic

team of professionals.

9/14/2014 12

Sales Specialist is responsible to meet or to exceed an annual sales target, as set by the Vice

President of Single-Use Sales. Sales targets are achieved via direct sales activity with customers and by working with local account managers.

Will provide the initial technical support for various purification technologies and support solutions that meet or exceed the customer’s expectations.

Responsible for supporting and communicating the business opportunities and strategies to management, as well as, local distributor sales organizations.

A strong understanding of Biopharmaceutical production processes operation design e.g. biotechnology proteins, vaccines.

Responsible for positioning, presenting and demonstrating Company’s single-use technologies

within our customers’ process development and manufacturing groups. Responsible for arranging and executing one-on-one or group sales meetings, “selling to the top,”

technology seminars and/or technology demonstrations. Responsible for facilitating the introduction of new products and technology.

Work Experience, Skills and Education Required: Bachelor of Science Degree in Engineering or Life Sciences with either a minimum of 5-years

experience in the biopharmaceutical manufacturing or process development areas, or 5 years sales experience in the biopharmaceutical market

20-30% overnight travel

************************************************************************ From: Tom Graham [mailto:tgraham@southtwinsearch.com]

South Twin Executive Search 1064 Gravel Road

Webster, NY 14580 Direct Office: (585) 216-1357

Subject: Help with my VP search please Johanna ...

Importance: High Good morning. I am hoping you may be in the position to refer an aspiring colleague for a fantastic

executive leadership opportunity with my client! My client is one of the hottest new start-up companies on the west coast and recently achieved their very

first new product approval in 2014! They are currently in a national search for the following executive level role: Corporate Head, Formulation, Manufacturing & Quality Control who will be chief strategist for all

CMC, manufacturing and quality initiatives for the company. Fr om the CEO: “We’re looking for the very best and brightest out there who are exceptional problem

solvers, have learned a great deal and who are ready to put it all together to build a best-in-class,

company!” Additionally, please know that I am offering a $1,000 referral bonus for any referral that accepts an offer

of employment for this exceptional opportunity! If you are interested in receiving the formal spec for this role for a colleague, please let me know and I

will be happy to send it along ASAP! ********************************************************************************

Contact: Ron Herman, Senior Partner, NexGen Consulting Group, LLC, rherman@nexgen.org

Our local client has basic ideas for secondary and tertiary package design for a new product launch. We need an expert packaging engineer experienced with auto-bottom cartons, perforated tear strips, perforated carton tops, blue line drawings, etc. Must be able to get up to speed immediately and move quickly to meet an aggressive timeline.

*********************************************************************************

Mack Mofidi, Ph.D.

Program Dean College of Engineering & Information Sciences

DeVry University, San Francisco Bay Metro

6600 Dumbarton Circle Fremont, CA 94555-3615

9/14/2014 13

p: 510-574-1181

f 510-742-1895 e: mmofidi@devry.edu

With the continued growth and success of our Biomedical Engineering Technology (BMET) program at the

DeVry University San Francisco Bay Metro, there is a need for more faculty to staff our classes. This person will need to be available to teach day-time classes, have field BMET experience and have a

minimum of a Master’s degree in their area of specialization.

https://devryuniversity-devry.icims.com/jobs/54418/visiting-faculty---biomedical-

engineering/job?mode=view

****************************************************************************

https://jobs.smartbrief.com/action/listing?listingid=8F607019-416C-40F5-9052-1433C473FD2D&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-

199b99dc80c0&utm_source=briefJob Summary

Date Posted: 8/22/14

Location: Multiple Locations, United States

FDLI SmartBrief Assistant General Counsel - Pharmaceutical R&D

GlaxoSmithKline Job Description

This position is based in the US. The role entails work across a broad legal spectrum germane to

development and commercialization of pharmaceuticals, including FDA-administered laws and regulations, fraud and abuse, product liability, privacy, antitrust, controlled substances, import-export, and contracting

with both government and private parties

Legal support, with the ability to work independently, for life-cycle management activities calling for deep knowledge of pharmaceutical regulatory law (e.g., “Hatch-Waxman” matters in the US) that are of high-

level strategic/financial/regulatory importance

Legal support, with the ability to work independently, for support of Global Regulatory Affairs at the

leadership team level on policy, product approval, and other matters calling for deep pharmaceutical regulatory law expertise and experience

Leads other professionals in the department by serving as source of information/training on matters

calling for deep pharmaceutical regulatory law

********************************************************************************** https://jobs.smartbrief.com/action/search;jsessionid=400DC945ED6ACC834031F95313C6DFCC.jobs2.sm

artbrief.com?searchtype=all&searchKeyword=&searchCity=&searchState=CA&searchCountry=&advanced

Title=&advancedCompany= Featured Job

Job Title: Marketing Manager

Company: Insight Education Group

Date Posted: 8/22/14

Location:

Washington, DC or Los Angeles, CA ____________________________________________________________________________________

__________________

9/14/2014 14

Job Title:

Business Development Analyst Company:

Insight Education Group Date Posted:

8/22/14 Location:

Los Angeles, CA ____________________________________________________________________________________

__________________

Job Title: Consultant - Los Angeles, CA (Full-time)

Company: Insight Education Group

Date Posted: 8/19/14

Location: Los Angeles, CA

____________________________________________________________________________________

__________________

Job Title: Director, Compliance - Health Plan Privacy & Security

Company: Kaiser Permanente

Date Posted: 8/30/14

Location:

Oakland, CA Job Title:

Sales Manager (Education K-12)

Company: ALL Management Corporation

Date Posted: 8/28/14

Location:

____________________________________________________________________________________

Los Angleles, CA Job Title:

Health Care Exchange Account Manager Company:

Kaiser Permanente Date Posted:

8/27/14

Location: San Diego, CA

Job Title: Senior Counsel, Regulatory (FDA)

Company: CareFusion

Date Posted: 8/25/14

Location:

San Diego , CA ____________________________________________________________________________________

Job Title:

9/14/2014 15

General Manager

Company: Airport Terminal Services, Inc.

Date Posted: 8/20/14

Location: San Jose, CA

____________________________________________________________________________________

Job Title: Healthcare Grants Specialist

Company: Los Angeles LGBT Center

Date Posted: 8/18/14

Location: Los Angeles, CA

____________________________________________________________________________________

Job Title: Counsel II, Legal (Anti-corruption)

Company: Gilead Sciences

Date Posted: 8/18/14

Location: Foster City, CA

____________________________________________________________________________________

Job Title: Sr Manager, Business Conduct

Company: Gilead Sciences

Date Posted: 8/18/14

Location: Foster City, CA

****************************************************************************

Jobs That Crossed My Desk Through August 31, 2014 *********************************************************************

Recruiter: Alison Bridges; Alison@legacymedsearch.com Recruiter Phone: 407-591-3028

The attached job opportunity may be a fit for you - or someone you know. If not a fit for you, please

forward to a friend, colleague or associate.

As always, thank you for your thoughts on this position or on how we can help you as you manage your career.

Job #1273-MH2620 Job Title: Director, Product Marketing - Biologics/Wound Care/Regenerative Medicine

Salary Range: 150000 to 175000 USD Location: New York, NY

Click here to apply (mobile compatible)

Director, Product Marketing: Biologics | Wound Care | Regenerative Medicine

NY/NJ

9/14/2014 16

Position Summary The successful Associate Director, Product Marketing will have at least 10 years of brand, product and/or

marketing management experience in the area of advanced wound care biologics, bone, cartilage or skin substitutes, osteobiogics, or tissue or regenerative medicine in a surgical setting . Your prior medical

device experience should include both patient-focused and clinician-physician marketing and you will have a strong understanding of medical terminology, especially as it relates to implantable, injectable or similar

surgical devices or wound care (allograft, xenograft, combination drug or biologic, or tissue). The ideal background for this role would be someone with a scientific, engineering or life science education

combined with an entrepreneurial marketing, patient-focused passion for creating products that improve

patient quality of life.

Position Responsibilities: Develop and maintain market information and provide marketing strategy for company’s portfolio

of products. Research, analyze, and remain informed about competitive products, pricing and strategy

Help develop and refine Price Strategy and Competitive Pricing/Share Analysis Work with multi-functional teams within the company to gain collaboration and full input for

programs

Develop resources to communicate and share information and Best Practices with the field sales force

Develop and maintain a network of strong relationships with Key Opinion Leaders in order to best develop ongoing educational programs in alignment with campaigns

Maintain consistent communication and feedback with external strategic partners Position Requirements:

10+ years of marketing experience in medical device, biologics OR pharmaceutical company division focused on wound care, tissue regeneration, dermal substitutes, combination devices or

similar products.

Proven ability to determine and communicate effective product positioning and key marketing strategies, including managing research and analysis of relevant therapeutic areas, competition,

product mix, and markets. Demonstrated ability to plan, organize, manage and execute on several marketing projects

simultaneously, within budget. Knowledge and familiarity with financial modeling and performance metrics of marketing

campaigns including researching, analyzing, and quantifying of portfolio products and competitive products.

Experience working with thought leaders and KOLs in advanced, wound care, advanced therapies

or regenerative medicine. Your prior experience may include marketing, R&D or product development roles within the

biologics, advanced technologies, spine, orthopedic / neuro / CMF or wound care division of companies such as 3M Healthcare, BSN, B.Braun, Beiersdorf, Covidien, Stryker, Shire, Biomet,

Integra LifeScience, Genzyme, Smith & Nephew, Coloplast, Lifecell, Convatec, Medela, Osiris, Human BioSciences, JNJ Synthes, Baxter Biosurgery or one of the companies listed at the bottom

of this job description.

Educational Requirements: Bachelors in Business, Marketing, Engineering, Life Sciences, or related field.

MBA or advanced sciences degree strongly preferred.

Base Salary : $150,000 – $175,000 Estimated Travel: 30%

Manages 2 direct reports Reports to: Vice President of Marketing (works closely with R&D)

Keywords for this Title Include: “Associate Director” Manager “Advanced Technologies” “Regenerative Therapeutics” Upstream Marketing Manager, Product Director, Product Manager, Project Manager, Product

Development Manager, Brand Manager

9/14/2014 17

Keywords for this position include: Osteobiologics, KOL, Medical Device, Product Introduction, Training

Development, Autograft, Allograft, MBA, “Combination Device” Annual Sales Budget, Voice of Customer, VOC, Wound Care, Advanced Wound Care, AWC, tissue, biologics, regeneration, Xenograft, Biologics

“Regenerative Medicine” Prior experience with one or more of the following companies would be beneficial: Osiris, Coloplast,

Hollister, Medela, Cytomedix, Synovis, Eloquest, Healogics, Amerigel, Z-Medica, Collagen Matrix, Alliqua, Smith & Nephew, Wound Care Innovations, B. Braun Medical, MTF, Anika Therapeutics, Osborn Medical,

Acell, Mimedx, ConvaTec, Thermogenesis, Kinetic Concepts, Ethicon, Cura Surgical, AcryMed, Advanced Biologics, Organogenesis, Covidien, Conmed, Systagenix,, Healogics, 3M Healthcare, Molnlycke, Convatec,

Baxter Biosurgery, Johnson & Johnson, AlloSource, Arthex, BSN Medical, Hollister, Organogenesis, MFT,

Shire Pharmaceuricals, ZMedica, KCI, 3M Helathcare, Angiotech, Avita Medical, Genzyme, the Hartmann Group, Hollister, Molnlycke, Systagenix, Medline, Polyheal, Spiracur, Synthes, Osiris Therapeutics,

Healthpoint Biotherapeutics, Laboratories Urgo, Apax Partners, WoundEl, Kalypto Medical, O2 Insights, Systagenix, Brennen Medical

NOTE: This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet

the ongoing needs of the organization. Legacy MedSearch ( www.LegacyMedSearch.com) is a boutique recruitment company exclusively serving

the medical device and healthcare technology industry. With 25 years+ in the healthcare industry, our

medical recruiting clinical expertise extends to most areas of surgery, surgical robotics, diagnostic & therapeutic imaging, surgical navigation and disruptive medical device technology.

Our firm works with OEM and contract manufacturers of IMD, AIMD and Class I, Class II and Class III devices with special emphasis on endoscopic and minimally invasive surgery, surgical robotic technology,

ablation and energy-based technologies such as wireless, RFID and sensor technologies that are in development for orthopedics, spine and spinal implants, neurosurgery, cardiology and cardiovascular and

other emerging medical technology including PMA, 510(k) and IDE products. FUNCTIONAL AREAS OF EXPERTISE

• C-Level and Executive Management

• Research & Development • Sales & Business Development

• Quality & Regulatory (QA/RA) • Clinical Affairs

• Product Management • Marketing, Clinical Marketing

ENGINEERING EXPERTISE • Program, Project and Product Management

• Human Factors

• Robotics • Embedded Software

• Imaging • Systems Engineers

• Test & Reliability Engineer • Quality Engineering

**************************************************************************

https://jobs.smartbrief.com/action/listing?listingid=83AD05BE-D85A-4ACD-B1A2-

19FDD117F7B1&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief

Job Summary

Date Posted: 8/18/14

Location: Foster City, CA

This Job appears in

FDLI SmartBrief Counsel II, Legal (Anti-corruption)

Gilead Sciences

9/14/2014 18

Job Description

Specific Responsibilities:

This position will report to the director of Gilead’s anti-corruption program within Commercial Legal. The individual will help implement an effective cross functional anti-corruption program at Gilead Sciences. The

individual will help develop and carry out policies and procedures; provide business conduct and compliance support to Gilead’s Access Operations and Emerging Markets (Gilead’s program to increase

access to medicines and healthcare in low- and middle-income countries); assess and act upon issues identified during due diligence processes; assist in implementing training and communication plans; and

contribute to monitoring, auditing and enforcement activities to ensure consistent application of Company

policies. The individual will work in close coordination with colleagues in Legal, Business Conduct, Internal Audit, Finance, and other departments to complement existing compliance activities.

Essential Duties and Job Functions: • Participate in implementation of the Company’s anti-corruption program, including assessment and

appropriate follow-up on issues identified during due diligence processes relating to engagement of third parties;

• Work collaboratively with other functional groups and relevant stakeholders to advance the Company’s anti-corruption program;

• Provide input on development and maintenance of anti-corruption-related policies;

• Provide business conduct and compliance support to Access Operations & Emerging Markets, including development and refinement of policies and procedures;

• Help develop and deliver training for employees and agents; • Assist in providing day-to-day guidance, support and problem solving;

• Participate in monitoring and reporting framework for key activities to assess the effectiveness of the program; analyze and monitor results to identify trends and recommend program improvements;

• Participate in cross functional audits of affiliates and third party agents and assist in implementation of corrective actions;

• Coordinate with other colleagues in Legal, Business Conduct, Internal Audit, and client departments on

an international basis to ensure efficient and effective implementation of program; • Assist in monitoring external environment and recommend improvements to the company’s anti-

corruption program based on identified industry best practices. • International travel required

Knowledge, Experience and Skills: • Requires a Juris Doctorate or equivalent advanced degree

• Bar admission • 6+ years of prior industry or law firm experience providing legal counsel relating to drugs, devices, or

food products. Experience in biotechnology or pharmaceutical industries preferred.

• Proven regulatory/pharmaceutical compliance experience with ability to analyze and interpret sales and marketing laws and regulations, and effect related organizational changes to ensure alignment.

• Demonstrated leadership and project management in enterprise-wide projects • Ability to present complex information in an accurate and persuasive manner to all levels of

management • Experience in fraud & abuse laws preferred (e.g., Foreign Corrupt Practices Act; UK Anti-Bribery Statute;

Anti-Kickback Statute)

Skills:

• Strong project management, communication and interpersonal skills. Substantial knowledge of specific

areas of law and business and ability to independently and effectively apply this knowledge to the relevant areas of responsibility to counsel members of the senior Legal team and senior managers in other

departments; • Responsible for identifying and analyzing risk associated with complex problems within area of

responsibility; • Must be a team player who can easily handle shifting priorities, multi-tasking in a deadline oriented

environment;

• Must be motivated and willing to take initiative; • Must have excellent written and verbal communication skills

• A Counsel II must demonstrate good judgment in their area of responsibility. Part of this judgment is

9/14/2014 19

demonstrated by how s/he reasons through issues and identifies those issues where the judgment of a

more senior attorney may be required before moving forward. ************************************************************************************

*****************************************

https://jobs.smartbrief.com/action/listing?listingid=16A864D1-1AA7-4235-9009-10A05B80E367&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-

199b99dc80c0&utm_source=brief

Job Summary

Date Posted: 8/18/14

Location: Foster City, CA

This Job appears in Sr Manager, Business Conduct

Gilead Sciences Job Description

Specific Responsibilities: This function will best be served by an individual with experience in the area of pharmaceutical

promotional compliance.

Under appropriate supervision and in collaboration with colleagues on the Business Conduct and Commercial Legal Affairs teams, take substantial responsibility for reviewing and monitoring promotional

materials and activities, as well as business strategies, associated with one of the company's discrete therapeutic areas, thereby enabling compliance with applicable legal and regulatory requirements.

Contribute to the periodic review, revision and supplementation of corporate and commercial compliance

policies and procedures to ensure they appropriately reflect legal and regulatory developments. Essential Duties and Job Functions:

•Provide regular training, and serve as a periodic resource, for company employees, consultants and employees of commercial partners, to help them understand and comply with applicable rules, policies and

procedures. •Assist with ongoing monitoring and auditing of commercial activities.

•Advance a positive spirit of partnership and collaboration with internal clients, internal legal colleagues and outside counsel.

•Appropriately triage a heavy workflow, setting appropriate priorities with clients and delivering results

within the reasonable agreed timelines. •Demonstrate ability to think creatively and devise solutions to challenging problems.

•Exercise mature and reliable judgment while enjoying the company's enthusiastic, informal and fast-paced environment.

Knowledge, Experience and Skills: 8+ years prior industry experience in a sales or marketing role, or 6+ years prior in-house or law firm

experience providing legal counsel on the laws and regulations relating to drugs, devices, or food products demonstrating growth and ability to succeed.

Typically requires a Juris Doctorate, but not mandatory.

Must have in depth skills and expertise within Business Conduct or policy creation, training and auditing. Must have excellent written and verbal communications skills.

Must have strong client service orientation.

*********************************************************************************************************************

https://jobs.smartbrief.com/action/listing?listingid=3F4B386E-E9C5-4DE9-B8A5-78F7524DF388&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7-b8c8-41a0-9df0-

199b99dc80c0&utm_source=brief

Job Summary

Date Posted:

9/14/2014 20

8/25/14

Location: San Diego , CA

Years Experience: 2-5

Job Contact Phone: 858-617-3201

Senior Counsel, Regulatory (FDA) CareFusion

Job Description

Life-changers work here CareFusion Life-changers find innovative ways to improve our customers' ability to provide healthcare to

their patients. One way is our search for bold and inspired employees across the globe. Are you ready to change lives? Join our 15,000 employees to help clinicians solve some of healthcare's most critical

challenges. Job Title: Senior Counsel, Regulatory

CareFusion Business Description

Regulatory (Attorney) is responsible for providing legal-FDA regulatory advice to legal, QRA, medical

affairs, and business staff concerning Federal and state FDA regulatory actions and issues - both proactively and reactively. Also responsible for review and advice pertaining to Company's response to

alleged regulatory actions and violations. Researches FDA, FTC, DEA, DOJ, CBP, and State BOP regulations, case law and statutes pertaining to regulatory agencies and the administrative process.

Supports business processes concerning specific legal-FDA regulatory matters and issues.

Accountabilities Provide assistance with regards to medical device and pharmaceutical FDA regulatory compliance.

Identify, recommend and implement where possible, corrective actions for regulatory and other related

processes. Review promotional information and product literature to ensure FDA and FTC regulatory compliance.

Review governmental rulings to determine changes and probable effects on facility activities. Correspond with the FDA, other regulatory agencies, customers, suppliers, and division personnel as

needed both orally and in writing to address regulatory inquires, problems, or requests. Report to VP, Associate General Counsel, Legal Regulatory; support department and practice area

initiatives. Perform duties in accordance with established company procedures and policies; perform other duties as

assigned.

What is expected of you for success in your role A licensed attorney and graduate from an accredited law school with a strong academic record

Demonstrates understanding of legal ramifications associated with actions by CareFusion and whether specific matters/issues may result in potential violations and/or negative legal-regulatory impact

Researches and assesses regulations, case law and statutes pertaining to regulatory agencies and the administrative process

Provides basic advice and counsel to businesses concerning specific legal-FDA regulatory matters and

issues Reviews and/or crafts basic administrative responses to agency allegations under supervision at a higher

level Works with outside law firm(s) to help further CareFusion initiatives that are contingent upon legal-

regulatory requirements

Qualifications Graduate of an accredited US law school

2-4 years’ experience in FDA regulatory law

Employee of law firm with Regulatory experience Undergraduate degree in the physical sciences preferred

9/14/2014 21

************************************************************************************

******************************************* Please send your resume/CV and a cover letter that specifically addresses this job posting as email

attachments to: jobs@sangamo.com

Director, Vector Production

Job ID: 19738622

Position Title: Director, Vector Production

Company Name:

Sangamo BioSciences, Inc.

Industry: Biotechnology

Job Function: Managerial

Location(s): Richmond, California, 94804, United States

Posted: August 20, 2014

Entry Level: No

Job Type: Full-Time

Job Duration: Indefinite

Min Education: Master's Degree

APPLY FOR THIS JOB

Save Job Email Job Print Job Apply For Job

Job Description

JOB SUMMARY:

The Director, Vector Production will oversee activities related to the Process Development and in-house non-GMP/cGMP production of recombinant Adeno-associated Viral Vectors (rAAV), and cGMP vector

production at contract manufacturing organizations (CMOs). ESSENTIAL FUNCTIONS:

1. Manage the Process Development, GMP production, testing and fill finish of rAAV products at CMO's 2. Manage internal activities related to the scale-up and production of rAAVs in house for use in R&D

and pending facility decisions 3. Lead in-house team producing rAAV

4. Co-ordinate production activities with research, non-clinical development, QA, QC and clinical

development 5. Ensure the ongoing security of the supply chain for raw materials and intermediates to ensure the

uninterrupted performance of rAAV operations 6. Co-ordinate the transfer, qualification and implementation of process improvements and scale-up

7. Lead the reporting, investigation and resolution of deviations encountered during GMP production activities

8. Participate in the design, construction and commissioning of company manufacturing facilities 9. Other activities as may be assigned

Job Requirements

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

The ideal candidate for this position will have in-depth experience of the large-scale cGMP production of rAAV, including upstream cell culture, downstream processing, and fill finish operations.

Candidate must possess: MS or Ph.D in bioprocessing, chemical engineering, vector biology, or biological sciences

Minimum of 10 years experience in the biotechnology or pharma industry with a primary focus on

upstream cell culture process development and manufacturing operations for biologics Proven track record of managing in-house and CMO GMP production operations

In-depth experience with: o Mammalian cell, insect cell and microbial cell culture systems at both pilot-scale and at

large-scale o Different bioreactor production systems and scales, including disposable-based culture

systems o CIP, SIP, WFI

In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements

Knowledge of Quality Systems and QBD as they relate to GMP production operations and process optimization

9/14/2014 22

OTHER REQUIREMENTS:

Experience of facility, and production equipment design and validation, including IQ, OQ & PQ a plus

Proven managerial skills Outstanding organizational skills

Excellent written and oral communication skills Ability to operate in a fast-paced, multi-disciplinary industrial environment

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including bonus and stock option plans. Sangamo offers a

comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday

time; access to a voluntary 401(k) and Employee Stock Purchase Plan. Sangamo is an equal opportunity employer.

*********************************************************************************

This position provides an excellent opportunity to contribute significantly to the continued growth of the

company. We provide a unique work environment, a competitive salary, stock options, and excellent

benefits. To apply, please include your name and this position title in the subject line of your email, and

send your CV or resume to: careers@igenica.com. We are an equal opportunity employer.

For further information about Igenica please visit our website at www.igenica.com.

Igenica Biotherapeutics, 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:

Scientist/Senior Scientist, Discovery Research

SUMMARY

Igenica has an exciting opportunity for a highly motivated PhD scientist to lead a research team in our Discovery Research unit. The successful candidate will play a key role in applying and advancing our

innovative proteomics technologies for the identification and characterization of novel therapeutic antibody and antibody-drug conjugate (ADC) targets for oncology. The candidate will also lead antibody/ADC drug

discovery projects from primary screening through in vivo proof of concept and IND filing.

PRIMARY RESPONSIBILITIES

The successful candidate will work within our Discovery Research team, contributing to the identification and validation of novel oncology drug targets in solid and hematological cancer indications. Candidate will

manage a small team of research associates and lead therapeutic discovery efforts against validated targets.

Candidates will be expected to:

Design and execute studies to prioritize and validate targets for entry into the drug discovery pipeline

As a member of the target discovery team, leverage Igenica’s proteomics platform to help identify

novel therapeutic targets from primary human tumor specimens Coordinate in vitro and in vivo characterization of Ab/ADC candidates to enable selection of lead

therapeutics Interact effectively with multiple groups within Igenica to facilitate the movement of promising

9/14/2014 23

targets/therapeutics into clinical development

Possess knowledge and experience in the use and maintenance of laboratory equipment and techniques such FACS, cell proliferation analysis, apoptosis assessment, fluorescence microscopy,

ELISA, molecular biology, gene transfer and stable cell line development Have effective communication skills as demonstrated by the ability to collaborate with internal and

external team members

QUALIFICATIONS, KNOWLEDGE AND SKILL REQUIREMENTS

The successful candidate will have a Ph.D. in Cell Biology, Pharmacology or a related field and several years of proven experience in target validation and/or drug discovery, preferably in oncology, as

demonstrated by a track record of publications and/or success in the industry. The candidate must have strong scientific leadership skills and the ability to work within a multi-disciplinary team. Prior experience

utilizing FACS, ELISA and cell-based assays, as well as managing multiple direct reports, is required. Knowledge and expertise in antibody/biologics drug discovery is preferred. Outstanding written/verbal

communication skills are also essential.

WORKING CONDITIONS/PHYSICAL DEMANDS

This is a research position that requires working in a laboratory environment with chemicals known to be highly toxic. Protective clothing, gloves and safety glasses are required while working in the lab.

Requires the ability to lift 25 pounds and work at a safety cabinet/laminar flow hood for extended periods of time.

TRAVEL REQUIREMENTS

Travel requirements are minimal (1 week or less per year) but may increase over time.

*********************************************************************** Qualified candidates please reply to:

Cindy Johnson cjohnson@chozeninc.com

tel: 925-577-8135

REGULATORY, QUALITY & CLINICAL AFFAIRS

Manager, Clinical Outcomes (Nursing & aesthetics background) Bachelor’s degree required. Medical/Nursing background strongly preferred.

3 yrs of hands-on experience in an aesthetic practice; or working experience in a medical device company which requires extensive interfacing with the end-users in a clinical content (for example,

a clinical trainer) is preferred. 1 yr customer service and/or complaint handling or other relevant experience is required.

Must have previous management experience leading a high performing team of individuals - 2

years preferred Expert knowledge of relevant medical conditions and terminologies.

Expert knowledge of technologies and treatment modalities in the field of aesthetic medicine is preferred.

Regional Clinical Specialist – RN (SF Bay Area based)

Licensed RN 2+ years of relevant medical device industry experience as a Clinical Specialist

Experience in acute care setting, complex, multiple contact points, project-oriented implementation

with products that require significant training and on-going support Ability to travel, up to 30%

Excellent interpersonal and communication skills; ability to adapt to changing work priorities Experienced in clinical training and education

9/14/2014 24

Regional Clinical Specialist – RN (Southern California based)

Licensed RN 2+ years of relevant medical device industry experience as a Clinical Specialist

Experience in acute care setting, complex, multiple contact points, project-oriented implementation with products that require significant training and on-going support

Ability to travel, up to 30% Excellent interpersonal and communication skills; ability to adapt to changing work priorities

Experienced in clinical training and education Sr. CRA ***URGENT*** SF Bay Area based positions (multiple contract openings)

BS/BA in a science or health care discipline

4 - 5 years of on-site monitoring experience in medical device industry 3 - 4 years of in-house study activity experience

Knowledge of GCP and applicable regulations Sound knowledge of medical terminology and clinical study monitoring

Orthopedic med device clinical trial experience strongly preferred Ability to travel up to 60% as study activities require

MANUFACTURING, OPERATIONS & R&D ENGINEERING Director of Operations

BS in Engineering discipline

10 -15+ years of experience in Manufacturing Operations Substantial industry experience in a global company

Proven leadership & management skills Exceptional verbal and written communication skills

Experience in the semiconductor industry would be a plus SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT

Marketing & Business Development Manager – OIL & ENERGY industry experience – field based role BS in Mechanical, Electrical or Industrial Engineering

10-15+ years of experience in business development & sales and have sold to large & small

companies as well as developing key accounts Sales & Business Development experience in the Oil & Gas industry (experience in other relevant

industries would include Aerospace, Manufacturing, Semiconductor, Gas, Automotive, Pipeline and Power Plant)

Ability to travel (US, Canada & Europe) Proven track record driving sales through distributors/partners

****************************************************************************

Jobs That Crossed My Desk Through August 24, 2014 ***************************************************************************

Contact Details Website:

https://home2.eease.adp.com/recruit/?id=13161032 Manager of Downstream Marketing--

Posted Fri, 08/15/2014 Job Info

Job Title:

Manager of Downstream Marketing Company:

iCAD/Xoft Location:

San Jose, CA, or Nashua, NH Job Type:

Full-Time Experience:

01-05 Years

Status: Active

Job Description

9/14/2014 25

Job Description:

The Manager of Downstream Marketing is responsible for all global downstream marketing activities for the Xoft portfolio of products for breast cancer (IORT and APBI). This position reports to the Vice

President, Global Marketing and works closely with Xoft’s cross functional team to drive business of all existing Xoft products.

RESPONSIBILITIES: · Develop and implement marketing programs to drive growth of adoption and increased utilization of

Axxent Electronic Brachytherapy systems and products. · Implement a comprehensive IORT marketing plan to drive clinical adoption including medical education,

luminary engagement, sales/applications specialist support and training, inside sales guidance, and

industry shows. · Support the implementation of Reimbursement and Clinical study/publication activities in order to drive

commercial growth. · Support implementation of marketing communications/collateral and industry trade show programs.

· Analyze existing business according to various segmentations to understand win/loss data. · Provide day-to-day front line support for Xoft’s direct sales force and applications specialists.

Experience Required: · 3-5 years medical device sales or field related experience

· Minimum of 2 years marketing experience in healthcare industry (medical devices/biotech/pharma

preferred) · Demonstrated ability to communicate complex/intangible products effectively

· Must be detail oriented, well organized and can handle multitasking with finesse · Knowledge of surgical/radiation oncology environment a strong plus

· Available to travel 25-30% of the time Education Required:

· Bachelor's degree in marketing, business-related degree

*************************************************************************

Contact Details Website:

https://home2.eease.adp.com/recruit/?id=13386012 Director, Strategic Partnerships--

Posted Fri, 08/15/2014 Job Info

Job Title: Director, Strategic Partnerships

Company:

iCAD/Xoft Location:

San Jose, CA, or Nashua, NH Job Type:

Full-Time Experience:

05-10 Years Status:

Active

Job Description Job Description:

The essential function of the position will be to spearhead the creation and development of a program that identifies and secures radiation oncology partnerships in the United States in support of the Xoft Electronic

Brachytherapy business. The scope of the role spans strategic planning through implementation including large national/regional radiation oncology networks as well as local individual providers.

RESPONSIBILITIES: - Work with senior staff to lead the development of the strategic framework and implementation plan for

radiation oncology partnerships with dermatology practices.

- Develop and grow partnerships with national and regional radiation oncology networks. - Identify, initiate, and develop partnerships with local radiation oncology providers

- Identify, develop and evolve the necessary documentation (credentialing, contracts, etc.) to implement

9/14/2014 26

the partnerships

- Ensure the partnership program is effectively marketed to the target audiences through the development of online and offline promotional channels e.g. web-based search tool

- Optimize utilization of the partnership network through integration with the company’s CRM tool - Effectively communicate cross functionally to ensure successful launch and growth of the program

Experience Required: Education and Background

This person would ideally have experience and professional connections with radiation oncology clinician leaders and national radiation oncology network executives and the following qualifications:

- Minimum 5 years of experience in a leading medical device company or an oncology network. Some

startup experience would be ideal. - Minimum 5 years of experience in radiation oncology

Sales territory management, executive sales, and/or national account sales experience - Ability to travel extensively - up to 50%

Character Traits - Versatile

- Self-starter - Strong relationship building/management skills

- Experience in negotiating alliances

- Easily grasp and synthesize technical, clinical and operational concepts - Able to deal with complexity

- Good working rapport with physicians, sales reps and co-workers - High energy

- Sense of humor - Creative and flexible when dealt setbacks or changed priorities

- Good planning and organization skills - Analytical

Education Required:

- BS in science or technology

************************************************************************** Contact Details

Website: https://home2.eease.adp.com/recruit/?id=13533302

Regional Business Development Manager (Dermatology/Medical Device)-- Posted Mon, 08/18/2014

Job Info

Job Title: Regional Business Development Manager (Dermatology/Medical Device)

Company: iCAD/Xoft

Location: OH/KY Region

Job Type: Full-Time

Experience:

01-05 Years Status:

Active Job Description

Job Description: POSITION DESCRIPTION:

Primary responsibilities of the Regional Business Development Manager are promoting and selling of Xoft’s Proprietary Electronic Brachytherapy products for the treatment of basal cell and squamous cell skin

cancer.

RESPONSIBILITIES: • Promote Xoft’s Proprietary Electronic Brachytherapy solution for the treatment of basal cell and

squamous skin.

9/14/2014 27

• Achieve sales goals and target as per variable compensation plan.

• Call points include: Dermatologists and practice management. Hospitals, C-Level Suites, Radiation Oncologists and Physicists.

• Stay current on account and sales funnel documentation via company Salesforce CRM. • Strategize with internal support staff on high level focus accounts to develop and maintain relationships

with key opinion leaders. • Work with clinical applications specialist to gain commitment from referring physicians to support

installed based customers. • Provide market and competitive intelligence to marketing team.

• Represent iCAD at trade shows as it relates to Xoft products

• Complete formal Xoft products training program in San Jose, CA. • Maintain expense control within corporate expense guidelines.

• Other duties as requested. LOCATION: This position will work out of a home office. Positions are currently available in the OH/KY

region. THE COMPANY:

Based in Sunnyvale, Calif., Xoft, now a subsidiary of iCAD, develops Electronic Brachytherapy (eBx) systems based upon miniaturized X-ray tube technology for the practice of radiation oncology in a broad

range of clinical settings, eliminating the need for heavily shielded environments. The Axxent treatment

platform provides a therapeutic dose of radiation directly to the region at risk with minimal radiation exposure to surrounding healthy tissue and without the logistics and costs associated with using

radioactive isotopes. FDA-cleared for treatment of early stage breast cancer, skin cancer and endometrial cancer, the Axxent System is also cleared for use in the treatment of other cancers or conditions where

radiation therapy is indicated including IORT. For more information please visit www.xoftinc.com. Xoft’s technology is being received with great enthusiasm by radiation oncologists, breast surgeons and

patients alike. This breakthrough technology will expand iCAD’s reach to a new and largely untapped market.

The parent company, iCAD, Inc., is known as an industry-leading provider of advanced image analysis and

workflow solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. With the recent acquisition of Xoft, Inc., an electronic brachytherapy

systems company, iCAD has been transformed from a company focused on image analysis for the early detection of cancers to a broader player in the oncology market. iCAD believes that early detection in

combination with earlier targeted intervention will provide patients and care providers with the best tools available to achieve better clinical outcomes.

In July 2014, iCAD acquired DermEbx a leading healthcare services and technology company dedicated to offering skin electronic brachytherapy programs to dermatology and oncology networks and Radion, Inc.,

a cloud-based oncology collaboration software solution.

COMPENSATION/ BENEFITS: iCAD offers a competitive salary, incentive stock options, and an exceptional benefits package including

outstanding medical and dental insurance, vision care, short- term and long-term disability, group life insurance, a comprehensive 401(k) plan complete with company matching, section 125 flexible spending

accounts for health and dependent care, tuition assistance, discounted homeowners and car insurance, pre-paid legal services, accident insurance and paid vacation & personal time off.

Experience Required: REQUIRED 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: • Stellar organizational, communication and presentation skills.

• Computer literate with dynamic PowerPoint presentation skills. • High level of “clean” strategic thinking and a history of excellent account management and documented

performance. • Ability to travel up to 75% within large regional geography.

EDUCATION AND EXPERIENCE: • Proven track record of medical/clinical dermatology sales

• 3 to 5 years of capital equipment sales experience to Dermatologists and C-level suites in Hospital

marketplace • Experience marketing a high tech disruptive technology to a sophisticated buyer.

• Comfortable and experienced in presenting a financial analysis, cash-flow analysis, ROI to CFO and

9/14/2014 28

controller positions.

• Experience with Medicare coding and billing is a plus. Education Required:

• Professional sales training through previous companies.

************************************************************************* Check out listing of jobs on BIO.org website at

http://jobs.bio.org/home/index.cfm?site_id=15768&_ga=1.211066453.1998428543.1403502594

Of the 94 jobs listed in California, these occurred since July 29th:

Development Associate IV

Sangamo BioSciences, Inc.

Point Richmond,

California, United States

08/20/2014

Director, Vector Production

Sangamo BioSciences, Inc.

Richmond,

California, United States

08/20/2014

Development Associate IV

Sangamo BioSciences, Inc.

Richmond,

California, United States

08/20/2014

Aquatic Biologist- Sacramento, CA

CH2M HILL

Sacramento,

California, United States

08/15/2014

Business Analytics Associates

ZS Associates

Thousand Oaks,

California, United States

08/12/2014

Vice President Strategic Alliance Management

ICON plc

Other / Non-US,

United Kingdom Other / Non-US,

Ireland

More...

08/05/2014

Cheminformatics Developer/Cheminformatician

Novartis

California, United

States

**********************************************************************

Employer Position Description Requirements

Location

Contact Post Date

DiscoveRx Manager,

Cell-Based

Screening and

Automation

We are seeking a

highly motivated and team-oriented

Manager of Cell-Based Screening

and Automation, reporting to the

Senior Director of Operations. In this

position, you will

supervise the operation of cell-

based screening platforms in the

QUALIFICATIONS,

SKILLS, AND BACKGROUND: •

M.S./Ph.D. in biology or chemistry or a

related discipline plus at least 8 years of cell-

based assay experience in an

industrial or academic

laboratory setting including microtiter

plate assay setup and execution. •

South

San Franci

sco, CA

qualified candidates

should submit a resume with cover

letter to jobs@discoverx.com

and reference job code DRx038-2014

in the subject line. No phone calls or in-

person inquiries

please.

8/18/2

014 5:50:3

9 PM

9/14/2014 29

Assay Operations

group. You will lead a group of

talented scientists, generating protein

biomarker data that support

preclinical drug development

activities for client

pharmaceutical companies,

including evaluation of

potency and efficacy in human

disease model systems,

identification of

potential clinical biomarkers, and

detection of potential off-target

effects. You will be working

cooperatively in a busy laboratory

environment,

responding to change with

flexibility and adapting quickly to

evolving circumstances.

This is an excellent opportunity for a

team player to

lead a multi-disciplinary

research/operations group focused on

innovating and applying primary

human cell-based technologies to the

development of

novel therapies. POSITION DUTIES

AND RESPONSIBILTIES:

The successful candidate will be

responsible for the day-to-day

operation of the

Assay Automation group including the

Experience with

operation, maintenance and

programming of laboratory automation

equipment in a high throughput screening

environment, cell-based assay design,

data analysis, and

computer programming is

essential. • Previous experience supervising

laboratory scientific personnel is strongly

preferred. • Must be able to lift at least 50

lbs. • Must be able to

work independently and have exceptional

interpersonal, organizational and

communication skills. • Essential techniques

include: o Experience with antibody-based

detection technologies

(ELISA, bead-based detection methods,

and/or other multiplexing solutions)

and other protein detection technologies.

o Hands-on expertise in programming

automated robotic

workstations. • Additional skills of high

value include: o Experience with high-

throughput cell-based screening o Experience

with antibody production and

screening o Solid

computer skills (Excel, PowerPoint, database,

and statistical programs like Prism

9/14/2014 30

HTS laboratory.

Duties will include: • Supervising the

HTS and Assay Automation groups

• Maintaining and developing the

automation used for high

throughput

screening in human cell-based

assays • Ensuring client data meet

internal QA/QC criteria and are

completed on time • Supporting the

Research and

Development group at BioSeek

developing novel disease-focused

assays • Evaluating new

detection technologies •

Identifying and

testing new equipment for

implementation in the lab •

Developing strategies for

streamlining work flow and increasing

capacity • Tracking

historical assay performance

metrics • Performing other

duties as required and assigned Daily

duties include: data analysis and

QA/QC; manage

HTS laboratory and Assay Automation

group; operation of the robotic

assay systems; maintenance of

new and existing software

applications and

tools; method development to

9/14/2014 31

support cell-based

HTS.

D

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>

DiscoveRx Account

Manager, Asia Pacific Sales

The

successful candidate

will be responsible

for selling and

promoting

DiscoveRx’s products and

services in the assigned

Sales Territory.

The Account Manager will

work with

the Product Specialists,

Product Manager and

Distributors to achieve

the sales targets. The

position’s

primary responsibilit

y will be effectively

prospecting to uncover

opportunities for

DiscoveRx’s

business. This position

resides within the

commercial organization

and reports to the

Director of

Market Developmen

t for Europe/Asia

Pacific. Position &

Duties: • Present

DiscoveRx

products and services

QUALIFICATIONS,

SKILLS, AND BACKGROUND: • A

minimum education of a BS/M.S. in Cell

Biology, Pharmacology or Biochemistry, Ph.D.

a plus • Some

knowledge of the drug discovery and

development process • Two to five years of

successful sales experience • Self-

starter who is a result and success oriented

individual with the

proven ability to develop and follow

through on sales tasks and plans • Excellent

interpersonal and relationship

management skills • Ability to work later

hours (such as 10 am-

7 pm) to communicate with Asia Pacific clients

• Excellent written and verbal communication

skills. Second language: Korean or

Mandarin is strongly preferred.

Fremo

nt, CA

Qualified candidates

should submit a resume with cover

letter to jobs@discoverx.com

and reference job code DRx037-2014

in the subject line.

No phone calls or in-person inquiries

please.

8/18/2

014 3:32:5

7 PM

9/14/2014 32

through

sales calls, lead follow

up, on-site seminars,

trade shows, and user

meetings • Technically

competent

and detail oriented on

all of DiscoveRx’s

product and service

portfolio • Write

quotations

for the opportunities

once requested by

the customer

and provide quotation to

customer

service • Maintain an

accurate sales

forecast which must

be updated weekly •

Identify new

groups within

existing accounts in

addition to meeting with

current customers •

Coordinate

field visits with field

scientists, specialists,

and local distributors

in the Asia Pacific

territory •

Contact leads within

9/14/2014 33

24-48 hours

and process leads in

sales managemen

t software within 7

days • Attend and

participate in

training meetings at

least twice a month •

Performs other duties

as required and assigned

• Overseas

travel to Asia Pacific

countries, primarily

China and Korea

expected to be around

25%

De

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>

eFFECTOR Therapeut

ics

Research Scientist -

DMPK

Provide in vitro and in

vivo ADME / DMPK

expertise to support drug

discovery and

development

of our oncology

programs. Candidate

will be responsible

for conducting

in vitro

ADME assays such

as clearance in

microsomes and/or

hepatocytes, plasma

protein

binding, CYP phenotyping

Must be proficient in the conduct of assays,

LC/MS/MS method development and

sample bioanalysis, and generation of

results for presentation to project teams.

Other relevant

experience in areas such as

physicochemical profiling (e.g.

solubility, permeability & formulation) or

experience with metabolite

identification is a plus.

Other Requirements: • B.S/M.S in chemistry

or related discipline with 10+ years or

Ph.D. with 5 years work experience •

Strong analytical skills (e.g. HPLC-UV, LC-MS,

UHPLC) • Ability to

design, execute, analyze and interpret

San Diego,

CA

ssperry@effector.com

8/15/2014

3:38:23 PM

9/14/2014 34

and

alternative metabolic

pathway mapping;

reversible and time-

dependent CYP

inhibition.

experiments with

minimal direct supervision • Ability to

operate, maintain, and troubleshoot problems

on LC/MS equipment • Proficient in Microsoft

Word, Excel and PowerPoint • Excellent

communication and

organizational skills • Ability to multi-task •

Positive and collaborative

disposition with the ability to work easily

within a team • Attention to detail

D

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The

British Embassy

Senior Science

& Innovation Officer

The Senior

Science and Innovation

(S&I) Officer,

based at the British

Consulate-General,

Atlanta, is

part of a network of

S&I officers throughout

the US lead by the Head

of Science and

Innovation

Network in the British

Embassy in Washington,

DC. The objectives of

the global S&I network

are: *

Influence science and

innovation policies of

governments, industry

and academia to

benefit the

UK * Improve UK

* Responsibility for

covering a broad range of science in Georgia

and neighbouring states * Providing

detailed information on S&I policy and best

practice for UK stakeholders *

Compiling and

contributing to reports for stakeholders,

including: senior UK scientists, learned

societies, UK policy maker, Government

Ministers and Parliament *

Supporting high-level

visits relating to science and innovation

* Horizon-scanning developments in

science, technology and policy * Managing

projects (such as workshops and visit

programmes)to

successful completion * Supporting broader

Consulate initiatives in support of UK

prosperity * Bachelor’s Degree in science or

related field with 6-8 years experience in the

research and

development base within the Consulate

Atlant

a, Georgi

a, United

States ,

30303

8/15/2

014 11:14:

00 AM

9/14/2014 35

policy based

on international

experience and

emerging opportunities

and challenges *

Stimulate

strategic science

collaborations to benefit

the UK and deliver wider

policy goals * Harness

international

technology partnerships

and investment

to grow UK The core

objective of this job is to

represent UK

science and innovation

interests in the Atlanta

and Miami Consulate

districts. This Officer

reports to

the Deputy Director,

Science and Innovation

(Boston-based) and

will work closely with

fellow S&I

Officers across the

US and colleagues

from other British

government departments

(e.g. UK

Trade & Investment,

district * Advanced

degrees (Masters or PhD level) preferred *

A demonstrated enthusiasm for

Science, Science Policy and the

Internationalisation of Science * Proven

ability to work

independently to develop a wide range

of high-level contacts within industry,

academia, and research bodies *

Ability to identify emerging technologies

in the US that align

with UK priorities and establish technology

partnerships, research collaborations, etc. *

Strong interpersonal skills, capable of

effectively interacting with members of the

public, science

community, and senior government officials *

Excellent writing and communication skills

with the ability to produce clear, concise

reports, and to present effectively to a range

of audiences *

Knowledge of UK science and innovation

strengths and capabilities is a plus *

Highly motivated, organised, and

resourceful * Self-starter capable of

working independently

with little guidance and oversight * Effective

team player * Reliable, positive and open to

new ways of working Under US State

Department requirements, the

Embassy may only

employ, as non-diplomatic staff,

9/14/2014 36

Press &

Public Affairs, and

UK science and research

funding bodies).

persons who are US

citizens, US Green Card holders or A or

NATO visa holders with EAD cards*. If you

hold a visa other than an A or NATO visa you

are not currently eligible to work at the

Embassy. Please refer

to our website for information on

exceptions to this policy at

www.gov.uk/government/world/usa. All

candidates will be subject to background

checks and security

clearance. *A visas or NATO visas with EAD

cards are acceptable at the Embassy,

Consulates, and British Defence Staff (BDS)

outposts. Apply Here: http://www.Click2Appl

y.net/x8yqgbv

De

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>

Beijing Genomic

Institute

Principle Scientist

(single cell isolation)

1. Develop and validate

new methods of

rare cell isolation and

identification. 2.

Coordinate

the sample collection

from hospitals

and assistant the

technology transfer. 3.

Mentor, train

and coach junior staff

in experimental

design, execution

and interpretatio

n. 4.

Develops and

1. Ph.D. in bioengineering/biotech

nology or a closely related discipline.

Overseas postdoctoral experience preferred.

2. More than 2 years experience in single

cell isolation. 3.

Excellent English writing and

communication skills. 4. A clear ability to

progress projects from concept to product

delivery. 5. Be able to lead and manager

teams

Shenzhen,

China

sliu@completegenomics.com

8/13/2014

11:07:46 AM

9/14/2014 37

coordinates

grants application,

monitor paperwork

related to grant

programs.

D

e

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>

Beijing

Genomic

Institute

Principle

Scientist

(single cell isolation)

1. Develop

and validate

new methods of

rare cell isolation and

identification. 2.

Coordinate the sample

collection

from hospitals

and assistant the

technology transfer. 3.

Mentor, train and coach

junior staff

in experimental

design, execution

and interpretatio

n. 4. Develops

and

coordinates grants

application, monitor

paperwork related to

grant programs.

1. Ph.D. in

bioengineering/biotech

nology or a closely related discipline.

Overseas postdoctoral experience preferred.

2. More than 2 years experience in single

cell isolation. 3. Excellent English

writing and

communication skills. 4. A clear ability to

progress projects from concept to product

delivery. 5. Be able to lead and manager

teams

Shenz

hen,

China

sliu@completegenom

ics.com

8/13/2

014

11:07:20 AM

D

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ls

>>

Beijing

Genomics Institue

Principle

Scientist (single cell

isolation)

1. Develop

and validate new

methods of rare cell

isolation and identification

. 2. Coordinate

the sample

collection

1. Ph.D. in

bioengineering/biotechnology or a closely

related discipline. Overseas postdoctoral

experience preferred. 2. More than 2 years

experience in single cell isolation. 3.

Excellent English

writing and

Shenz

hen, China

sliu@completegenom

ics.com

8/13/2

014 11:06:

40 AM

9/14/2014 38

from

hospitals and

assistant the technology

transfer. 3. Mentor, train

and coach junior staff

in

experimental design,

execution and

interpretation. 4.

Develops and

coordinates

grants application,

monitor paperwork

related to grant

programs.

communication skills.

4. A clear ability to progress projects from

concept to product delivery. 5. Be able to

lead and manager teams

D

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s>

>

Complete

Genomics

, Inc.

Senior

Director,

Computational Biology

Complete

Genomics is

looking for an

exceptional expert and

leader for a group of

bioinformatics scientists,

mathematici

an, and computer

scientists to assist the

development and

application of methods

and tools for

complete genome

sequence assembly

and analysis. The ideal

candidate will possess

a broad

understanding of machine

- Ph.D. in computer

science, mathematics,

engineering, bioinformatics,

biostatistics, (or biology/genetics, along

with a very strong algorithm development

background) - 10+ years of machine

learning especially in

biology and genomics, 5 + years of

management experience -

Experience in modeling regulatory gene

networks - Previous experience

manipulating and

analyzing very large data sets essential.

Software skills appropriate for this

analysis (shell scripting, Perl/Python,

C/C++, SQL, etc.) - Strong signal

processing experience

and background - Understanding or have

Mount

ain

View, CA

careers@completege

nomics.com

8/7/20

14

3:36:40 PM

9/14/2014 39

learning

algorithms, high-end

computing, genomics,

genetics, bioinformatic

s, have superior

leadership

and cross-functional

communication skills,

and be able to

successfully manage

complex

projects and influence

multi-disciplinary

teams. Responsibiliti

es - Develop machine

learning

strategy in genomics

including building a

team of machine

learning experts -

Design and

develop algorithms

with emphasis on

genomics - Adapt and

develop analysis

approaches

and software tools for the

use of complete

genome sequence -

Interact with the research

and

development groups to

background experience

with high performance computing -

Demonstrated independent thought

and judgment in developing methods,

techniques and evaluation criteria -

Knowledge of key third

party software platforms, tools and

databases for sequence analysis a

plus - Familiarity with common statistical and

data mining techniques used in analyzing

biological data a plus -

Strong problem-solving skills and

ability to think creatively - Strong

statistical analysis skills - Energetic and

motivated self-starter - Ability to learn quickly

in a fast-paced startup

environment - Work in a team environment

with a professional and positive attitude,

influence cross-functional teams -

Excellent analytical, problem solving,

communication, and

presentation skills Other requirements: -

Fluent communication skills in English and

Mandarin required - Travel at 30% - 50%

9/14/2014 40

implement

new product offerings -

Prototype data delivery

and analysis tools for new

products - Comparative

analysis of

sequence data from

collaboration projects -

Performs other work

related duties as

assigned

De

ta

il

s>

>

Complete Genomics

, Inc.

Senior Director,

Computational Biology

Complete Genomics is

looking for an

exceptional expert and

leader for a group of

bioinformatic

s scientists, mathematici

an, and computer

scientists to assist the

development and

application

of methods and tools for

complete genome

sequence assembly

and analysis. The ideal

candidate

will possess a broad

understanding of machine

learning algorithms,

high-end computing,

genomics,

genetics, bioinformatic

- Ph.D. in computer science, mathematics,

engineering, bioinformatics,

biostatistics, (or biology/genetics, along

with a very strong algorithm development

background) - 10+

years of machine learning especially in

biology and genomics, 5 + years of

management experience -

Experience in modeling regulatory gene

networks - Previous

experience manipulating and

analyzing very large data sets essential.

Software skills appropriate for this

analysis (shell scripting, Perl/Python,

C/C++, SQL, etc.) -

Strong signal processing experience

and background - Understanding or have

background experience with high performance

computing - Demonstrated

independent thought

and judgment in developing methods,

careers@completegenomics.com

8/7/2014

3:36:29 PM

9/14/2014 41

s, have

superior leadership

and cross-functional

communication skills,

and be able to

successfully

manage complex

projects and influence

multi-disciplinary

teams. Responsibiliti

es - Develop

machine learning

strategy in genomics

including building a

team of machine

learning

experts - Design and

develop algorithms

with emphasis on

genomics - Adapt and

develop

analysis approaches

and software tools for the

use of complete

genome sequence -

Interact with

the research and

development groups to

implement new product

offerings - Prototype

data delivery

and analysis tools for new

techniques and

evaluation criteria - Knowledge of key third

party software platforms, tools and

databases for sequence analysis a

plus - Familiarity with common statistical and

data mining techniques

used in analyzing biological data a plus -

Strong problem-solving skills and

ability to think creatively - Strong

statistical analysis skills - Energetic and

motivated self-starter -

Ability to learn quickly in a fast-paced startup

environment - Work in a team environment

with a professional and positive attitude,

influence cross-functional teams -

Excellent analytical,

problem solving, communication, and

presentation skills Other requirements: -

Fluent communication skills in English and

Mandarin required - Travel at 30% - 50%

9/14/2014 42

products -

Comparative analysis of

sequence data from

collaboration projects -

Performs other work

related

duties as assigned

De

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il

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>>

Genentech

Associate Scientist/Scient

ist DMPK (Transporter

Technology)

Passionate About

Science We’re

passionate and rigorous

about our

science. For more than

30 years, Genentech

has been at the forefront

of the biotechnolog

y 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

South San

Francisco, CA

headquarters: Associate

Scientist/Scientist DMPK

(Transporter Technology)

Responsibiliti

es: The department

The desired candidate should have a Ph.D. in

Pharmaceutical/Biological Sciences or other

relevant field, with 0-2 years’ industry

experience. Broad and

thorough knowledge of biology of drug

transporters, extensive experience in

cell/tissue culture, molecular biology

techniques (e.g. transporter

expression) and ability

to design and conduct assays as well as

analyze/interpret data are essential. Strong

understanding of transporter

involvement in drug disposition is required.

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. Apply Below! Now a

member of the Roche

Group, Genentech has multiple medicines on

South San

Francisco,

California,

United

States,

94080

Human Resources 8/6/2014

8:54:14 PM

9/14/2014 43

of Drug

Metabolism and

Pharmacokinetics (DMPK)

at Genentech is

seeking a highly

motivated

individual to support drug

permeability and

transport studies

enabling the discovery

and

development of small

molecule drugs. In

this lab-based

position, the qualified

candidate

will work closely with

our established

team to develop

assays and systems to

investigate

expression and

functions of drug

transporters, and conduct

in vitro permeability

and

transport studies to

address ADME

questions and support

projects. The successful

candidate

would have the

the market for cancer

and other serious illnesses. Genentech is

an Equal Opportunity Employer:

Minorities/Women/Disability/Veteran. Apply

Here: http://www.Click2appl

y.net/hz7ybkk

9/14/2014 44

opportunity

to interact with

multidisciplinary project

teams.

************************************************************************ Please respond to wirth@wirth-associates.com for detailed job descriptions.

Nancy Cody

Wirth & Associates wirth@wirth-associates.com

_________________________________________________________________________ Director, Manufacturing, Tech Services

CA _________________________________________________________________________

Manager, Manufacturing Tech Services CA

________________________________________________________________________

General Manager CA

The General Manager is the functional head of all operations at the site for successful day-to-day activities. As the General Manager, you will be responsible for the administrative and functional areas of

manufacturing, maintenance, engineering, materials management, and safety.

________________________________________________________________________

Sr. Director, Strategic Sourcing

CA This role will act as a head department leader for Company to deliver contract manufacturing and

procurement solutions to the Operations team. This position will lead cross functional discussions and will be required to navigate all organization tiers to develop and sustain agreements that support our

relationship model.

________________________________________________________________________

Director, Global Engineering Services.

CA This is a corporate role responsible for facilities, EHS and Security on a company wide basis. managing

large capital projects including facility remodels for technical laboratory space as well as general office space.

________________________________________________________________________

Head, Tech Support - Reports to CEO TX

Process development and validation for oral dosage forms (solids and liquids). Validation for oral dosage forms focused on product sampling and analytical testing in the laboratory to

show uniformity of a batch. Powder thief sampling and executed tablet press speed studies.

Strong technical person (understanding of manufacturing, packaging, formulation, validation,

Troubleshooting – all aspects including process, packaging, cleaning) but need a person willing to do the Hands On duties.

9/14/2014 45

________________________________________________________________________ Director, Engineering and Maintenance

NY Capital Budgets and Execution of Capital Projects

Planning and Directing all Facilities Engineering and Maintenance Security

Leading Technical Teams in meeting the needs of Operations, Internal and External Customers.

________________________________________________________________________

Senior Manager Engineering Technologies

PA Execute and implementation engineering technology projects across the global manufacturing network.

Support Company's technology needs including solid dosage forms, injectable, transdermal, medical devices, and/or biological products.

________________________________________________________________________

Director, Packaging Engineering (Offer Pending)

California Commercial Packaging, Labeling and Design Operations group.

________________________________________________________________________

Sr. Proj. Process Eng.

Southcentral US Extremely visible role with critical input on reconfiguration of existing process equipment as well as

selection and installation of

compounding and filling equipment for sterile drug manufacturing and water, HVAC and utilities - to include commissioning and

validation. ________________________________________________________________________

Senior Technical Services Manager - TX

This individual will manage all aspects of parenteral drug product commercialization.

________________________________________________________________________

Engineering Director

Taiwan Manage the Engineering group in development of project scope, design, and construction of projects

within agreed cost and schedule parameters.

*********************************************************************

https://jobs.smartbrief.com/action/listing?listingid=75F225B3-F6D1-4668-A700-277B33A5DD0C&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-

9df0-199b99dc80c0&utm_source=brief

Job Summary Date Posted:

8/15/14 Location:

Santa Ana, CA

Salary Range: Open

Years Experience:

9/14/2014 46

5

MGR POST MARKET STUDIES - 14000001LK Abbott

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.

Follow us on LinkedIn

Primary Job Function

Under the supervision of the Assoc. Director Post Market Studies, the Manager Post Market Studies

function is to drive the strategic Regional Phase IV initiatives for their respecitve SBUs (strategic business unit), while further developing Abbott Medical Optics clinical physician advocate base within these

respective areas. This individual's function also includes ensuring the phase IV post marketing study strategy and intitiatives are in allignment with the marketing teams they support as well as the Global

Medical Strategy team across Abbott Medical Optics.

The Manager of Post Marketing Studies also maintains current scientific knowledge in ophthalmology with

specific emphasis on their respective areas of responsibility. Interacts with Marketing, Sales, R&D, Legal, Regulatory and Clinical for medical support. Seeks out information from medical and scientific

literature, scientific meetings, symposia, and seminars that differentiates Abbott Medical Optics products from the competition, and supports key opinion leader initiated research.

Core Job Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

The Manager of Post Market Studies is responsible for ensuring strategic allignment of all Phase IV projects across their respective regional business units as well as communicating these strategic Phase IV

initiatives across the Global Medical Strategy team. This individual works with the key opinion leaders in their respective areas of focus to support the development of data which answers medically relevant

questions and provides clinical differentiation that can potentially be utilized in promotional and

educational activities in support of their respective divisions of Abbott Medical Optics. This person has direct responsibility for submitting all regional physician initiated study proposals within their area of focus

as well as facilitating the respective global Phase IV submissions under the post market study grant approval process. This individual reviews all relevant literature sources for new data/competitive

materials and study proposals related to his or her respective area of specialty, and disseminates these to the relevant teams. This person stays abreast of

all competitive and technological data and presentations.

Attends all relevant MD and OD scientific congress meetings. Works cross functionally with Marketing,

Sales, R&D, Legal, Regulatory and Clinical to execute overall strategy. Supports key opinion leaders for the respective post marketing study initiatives and publication deliverables. Targets and develops new

thought leaders in the area of laser vision correction, ocular surface disease, and contact lens cleaning solutions. Manages their respective Phase IV budget and timelines to ensure high productivity/efficiency.

Regular presentations to business unit teams, advisory boards, and investigator groups.

Position Accountability / Scope

- Resonsible for managing regional Phase IV initiatives across their respective SBU(s)

- Working with approximately 30 to 40 key opion leaders either directly or indirectly through phase IV

9/14/2014 47

team

- Managing the Regional Phase IV budget within their respective area of focus Minimum Education

Bachelor's Degree or equivalent experience MBA a preferred

Minimum Experience / Training Required

5-7 years experience in professional biotechnology, pharmaceutical or medical device company including Sales, Brand Marketing, Medical Marketing/Medical Strategy, R&D and Professional Education

*************************************************************************

************************************************************************* Other Information for Those in Transition

*************************************************************************

***********************************************************************

32 Biotech and Pharma Recruiters at Source: http://www.genengnews.com/insight-and-intelligence/32-

biotech-and-biopharma-recruiters/77900088/?page=1 ************************************************************************

4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at

http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/

See article entitled “6 Ways to Crack the Hidden Job Market” about cracking the hidden job market where 80% of jobs are found. The article was written by Nancy Collamer, M.S., is a career coach, speaker and

author of Second-Act Careers: 50+ Ways to Profit From Your Passions During Semi-Retirement. Her website isMyLifestyleCareer.com; on Twitter she is @NancyCollamer.

http://www.forbes.com/sites/nextavenue/2013/08/12/6-ways-to-crack-the-hidden-job-market/2/ ********************************************************************

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. *****************************************************************

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

See Beyond Borders Matters of Evidence 2013 biotechnology report at http://www.ey.com/Publication/vwLUAssets/Beyond_borders/$FILE/Beyond_borders.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

9/14/2014 48

_____________________________________________________________

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 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

9/14/2014 49

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 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

9/14/2014 50

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 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.

************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo

Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/

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. *********************************************************************

9/14/2014 51

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

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/

9/14/2014 52

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.

*************************************************************************