Jobs That Crossed My Desk Through Aug...2/7/2016 1 Jobs That Crossed My Desk Through Feb. 7, 2016...

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2/7/2016 1 Jobs That Crossed My Desk Through Feb. 7, 2016 Complimentary Service of Audreysnetwork.com Feb. 7, 2016 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. ***************************************************************************** Senior Research Specialist Sterling-Hoffman Life Sciences Email: [email protected] www.sterlinglifesciences.com Subject: Director of Regulatory Affairs with growing Pharmaceutical company in Northern, CA Our firm was hired by a growing pharmaceutical company in Northern, California to help them find an experienced Director of Regulatory Affairs experience and who must have IND/NDA filing experience and also Biologics, Oncology, and/or hematology, solid tumor, background is a plus. Here is link of job description http://goo.gl/Jaam8F Anyone interested can directly apply online and resume will come to me. They are looking to hire immediately so please feel free to share this information with anyone you think would want to learn more. By sending a resume, CV, or employment information to Sterling-Hoffman Life Sciences, or by requesting to work with one of our Associates or Recruiters, you acknowledge that you have granted permission to Sterling-Hoffman Life Sciences to utilize that information to assist you in your job search. ************************************************************************************ Jobs That Crossed My Desk through Jan. 31, 2016 ********************************************************************* Our startups and affiliates are hiring. See selected, recently posted openings below. We maintain current job listings at http://jobs.qb3.org/?mc_cid=4bcd2636b2&mc_eid=[UNIQID]. If you would like to post an opening on our website, please contact us with your name, email address, and company name. We will forward this to VentureLoop, the third party who manages our job listings. They will contact you and set you up with access to a free account so you can manage your own posting details. Job Title: Machine Learning Scientist https://ventureloop.com/ventureloop/jobdetail.php?jobid=394510&mc_cid=4bcd2636b2&mc_eid=[UNIQI D] Job Date: 01-22-2016 Duration: Full-Time Company: Atomwise

Transcript of Jobs That Crossed My Desk Through Aug...2/7/2016 1 Jobs That Crossed My Desk Through Feb. 7, 2016...

Page 1: Jobs That Crossed My Desk Through Aug...2/7/2016 1 Jobs That Crossed My Desk Through Feb. 7, 2016 Complimentary Service of Audreysnetwork.com Feb. 7, 2016 If interested in a listed

2/7/2016 1

Jobs That Crossed My Desk Through Feb. 7, 2016

Complimentary Service of Audreysnetwork.com

Feb. 7, 2016

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.

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

Senior Research Specialist Sterling-Hoffman Life Sciences Email: [email protected] www.sterlinglifesciences.com

Subject: Director of Regulatory Affairs with growing Pharmaceutical company in Northern, CA

Our firm was hired by a growing pharmaceutical company in Northern, California to help them find an experienced Director of Regulatory Affairs experience and who must have IND/NDA filing experience and also Biologics, Oncology, and/or hematology, solid tumor, background is a plus. Here is link of job description – http://goo.gl/Jaam8F

Anyone interested can directly apply online and resume will come to me. They are looking to hire immediately so please feel free to share this information with anyone you think would want to learn more.

By sending a resume, CV, or employment information to Sterling-Hoffman Life Sciences, or by requesting to work with one of our Associates or Recruiters, you acknowledge that you have granted permission to Sterling-Hoffman Life Sciences to utilize that information to assist you in your job search.

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

Jobs That Crossed My Desk through Jan. 31, 2016

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

Our startups and affiliates are hiring. See selected, recently posted openings below. We maintain current

job listings at http://jobs.qb3.org/?mc_cid=4bcd2636b2&mc_eid=[UNIQID].

If you would like to post an opening on our website, please contact us with your name, email address, and

company name. We will forward this to VentureLoop, the third party who manages our job listings. They

will contact you and set you up with access to a free account so you can manage your own posting details.

Job Title: Machine Learning Scientist

https://ventureloop.com/ventureloop/jobdetail.php?jobid=394510&mc_cid=4bcd2636b2&mc_eid=[UNIQI

D]

Job Date: 01-22-2016

Duration: Full-Time

Company: Atomwise

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Job Location(s): San Francisco, CA, US

Description: We’re looking for a colleague to help us develop new machine learning algorithms, by taking

the techniques that have worked for images or speech and creatively applying them to the field of

biochemistry. Atomwise is pioneering the use of deep neural networks to make the discovery of new

medicines much more efficient. We’ve shown that DNNs can autonomously discover features that impact

whether a potential medicine will be effective or toxic.

You’ll get to:

Research and develop deep-learning algorithms to improve and extend our current computational drug

discovery framework.

Explore novel machine learning approaches to be applied across the drug-discovery pipeline.

Communicate our results and capabilities through scientific publications.

No prior knowledge in biology/chemistry is required.

Qualifications

PhD in computer science, statistics, math, or related fields.

Proven track record of machine learning research (either in the academia or industry).

Good knowledge of C/C++ and Python.

Nice-to-haves:

Experience with developing Deep-Learning algorithms.

Experience in GPU programming.

Experience with AWS (EC2).

Undergraduate knowledge of (bio)chemistry.

Experience in analyzing biological data.

__________________________________________________________________________

Job Title: Scientist

https://ventureloop.com/ventureloop/jobdetail.php?jobid=402962&mc_cid=4bcd2636b2&mc_eid=[UNIQI

D]

Job Date: 01-22-2016

Duration: Full-Time

Company: ZymoChem

Job Location(s): Berkeley, CA, US

Description: ZymoChem seeks a scientist to join its R&D team. As a member of a young startup team you

will have the opportunity to build a game-changing technology from the ground up. This requires an

entrepreneurial-level initiative, the ability to demonstrate scientific leadership, and probably working a bit

more than regular hours. Your primary responsibility will be to engineer microbes by incorporating novel

biosynthetic pathways. Additionally, you will also be a part of other efforts directed towards furthering

ZymoChem's technology. An ability to effectively communicate and work with a team in a fast-paced

environment is crucial. If this fits your career goals, please apply below or submit your CV and cover

letter. We are looking for candidates to start immediately. ZymoChem is an equal opportunity employer.

QUALIFICATIONS

PhD in molecular biology, chemical engineering, biochemistry, bioengineering or a related discipline.

Proven high-impact publications and achievements.

Proven expertise in engineering E. coli and/or yeast.

Excellence in building and testing metabolic pathways for the production of chemicals.

Expertise in state-of-the-art techniques for gene knockouts and other genome engineering techniques.

Experience in -omics techniques for analyzing/optimizing pathway fluxes.

Experience in carrying out lab-scale microbial fermentations and operating bioreactors (1-10L) is a plus.

Experience with high-throughput enzyme expression, engineering, and activity screening a plus.

Prior experience in a startup environment a plus.

__________________________________________________________________________

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Job Title: Research Scientist

https://ventureloop.com/ventureloop/jobdetail.php?jobid=403320&mc_cid=4bcd2636b2&mc_eid=[UNIQI

D]

Job Date: 01-22-2016

Duration: Full-Time

Company: Nano Hydrophobics

Job Location(s): Berkeley, CA, US

Description: Nano Hydrophobics, Inc. (“Nano”), located in the Bay Area, is an early stage company

conducting energy efficiency research to overcome “the last major obstacle to heat transfer”, which

currently is responsible for wasting about one percent of U.S. energy consumption. Nano has an exciting

opening for a post-doctorate research scientist (RS). As an integral part of Nano’s small research team,

the RS will be responsible for the day-to-day operation of material testing in lab-scale heat exchangers..

Given Nano’s test protocols, the RS must have a high attention to detail and safety. The RS will be

responsible for planning and executing testing and characterization activities defined by Nano’s senior

scientist in support of the development on antifouling coatings to improve thermal transfer in heat

exchange systems.

Job Responsibilities included, but not limited to, the following:

Execute research experiments, in the area of polymer/materials science

Assemble, disassemble, and clean test devices for bench and field testing

Generate and collect analytical data and results from sample characterization

Keeps accurate records of results in laboratory notebooks and databases

Generate periodic reports of test results

Operate test systems and perform routine troubleshooting

Plan and execute project tasks in a safe and cost effective manner

Provides guidance and assistance to fellow researchers when needed

Participates in all required safety meetings & training programs

Order materials and maintain an organized, clean lab environment

Requirements

A Ph.D. (or possibly a Masters degree) in chemistry, chemical engineering, materials science or a related

science

A strong work ethic, high energy and intellectual curiosity

Initiative to constantly improve processes and working routines

Flexibility and keen pursuit of innovation throughout all processes in the continuous search of sustainable

new ideas

Strong desire to develop and grow by way of taking responsibility and engaging in additional tasks and

operations

Minimum Competencies:

Experience in organic chemistry/polymer/materials sciences lab

Strong lab skills and ability to work on multiple tasks and projects

Experience in material characterization techniques

Desire to learn new techniques with minimal training

Strong computer skills plus ability to organize and interpret data

Fluent spoken and written English language skills - mandatory

Strong communications skills (oral and written)

Computer skills including proficiency with Microsoft Office

Ability to work well on a team of peers in a very fast paced environment

Desired Qualifications:

Prior experience in a start-up or Industry is a plus

Requirement: U.S. citizenship or existing authorization to work in the United States indefinitely without

restrictions or sponsorship. We are currently seeking only local candidates who reside in the San Francisco

Bay Area. Only candidates who presently live within a daily commuting distance of Berkeley, CA will be

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considered. Applicants from outside the Bay area will not be acknowledged.

Primary Location

United States-Berkeley-California

Full-time, 40 hrs./week with extended work hours from time to time

Salary range:

Based on education and experience

Stock Options:

Potential to receive stock options in an exciting company based on individual performance

Respond To:

Please send your current resume and a cover email which describes your lab skills and experience.

We look forward to hearing from you.

__________________________________________________________________________

Job Title: Research Scientist

https://ventureloop.com/ventureloop/jobdetail.php?jobid=440958&mc_cid=4bcd2636b2&mc_eid=[UNIQI

D]

Job Date: 01-21-2016

Duration: Full-Time

Company: Adheren

Job Location(s): Emeryville, CA, US

Description: POSITION SUMMARY

We are seeking a highly motivated individual with entrepreneurship to join the Adheren R&D team to push

forward our T cell therapy against cancer. The successful candidate will work with our research team on

developing novel therapeutic agents for cancer immunotherapy. He/she will be expected to have the

ability to execute the designed experiments in a collaborative environment.

SKILLS REQUIRED

A Ph D degree in molecular biology, cell biology, immunology or related area with interdisciplinary

background. Experience in cell culture, basic molecular biology, flow cytometry, and immunoassays are

preferred. An understanding of the T cells or NK cells is appreciated. Applicants should convey robust

analytical skills, a strong record of achievement, and demonstrated ability in effectively interacting with

teams.

__________________________________________________________________________

Job Title: Senior Research Associate/Associate Scientist (Contract)

https://ventureloop.com/ventureloop/jobdetail.php?jobid=371099&mc_cid=4bcd2636b2&mc_eid=[UNIQI

D]

Job Date: 01-21-2016

Duration: Full-Time

Company: Accurus Biosciences

Job Location(s): Berkeley, CA, US

Description: We are seeking a highly skilled and motivated employee who is interested in growth

opportunities in a fast paced startup environment.

SUMMARY OF JOB DESCRIPTION: The successful candidate will perform a range of duties critical to our

hybridoma antibody discovery process.

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The primary responsibilities of this position include:

I) Culture and maintain mouse myeloma cell lines; perform mouse hybridoma cell fusions; establish

hybridoma cell cultures; perform hybridoma antibody screening, subcloning and binding affinity analysis.

II) Routine mammalian cell cultures and cell line maintenance. Perform mammalian transient transfection

and stable selection. Analysis of cell surface receptor expression using FACS based technologies.

ESSENTIAL SKILLS AND REQUIREMENTS:

I). The candidate should have a Bachelor’s degree in Biology with 3-5 years of post-graduate relevant

research experience or a Master’s degree with 1-3 years of post-graduate relevant research experience.

II). Hands-on experience and skills in hybridoma antibody fusion and screening is required. Experience

with antibody binding & affinity assays such as ELISA and FACS is essential. Experience with general

molecular biology and protein characterization is a plus.

III). The candidate must be a self-motivated, detail-oriented and well organized person. He/she is

expected to have the ability and desire to work in a fast paced, team-oriented environment. This

candidate is expected to design experiments independently, keep comprehensive experimental records

and have excellent written and verbal communication skills.

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

Qualified candidates please reply to:

Cindy Johnson

[email protected]

tel: 925-577-8135

Below you will find our most urgent positions in the San Francisco bay area unless otherwise noted.

Detailed descriptions are available if you would like to learn more. You are welcome to pass this along to

folks that may be qualified and interested. If you have any questions, please get in touch.

SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT

Marketing Communications Manager

Bachelor’s Degree

5 years of relevant marketing communications experience

Medical Device / Medical Products experience a plus

Strong project management skills

Demonstrated ability to work well with outside vendors on marketing materials

Must have excellent verbal and written communication skills

Proficient with spreadsheet, word processing and email software programs

Product Manager

Bachelor’s degree required

3 - 5+ years of marketing experience in medical device industry

Strong project management skills

Demonstrated skills to handle a variety of assignments simultaneously

Able to work under pressure and meet tight deadlines

Must have excellent verbal and written communication skills

Proficient with spreadsheet, word processing and email software programs

Sr. Marketing Manager (DTC, Digital Marketing)

Bachelor’s Degree or equivalent experience required (MBA preferred)

Minimum 8 years related experience in medical device and/or health & wellness

Working knowledge of the medical device industry is a plus

Experience developing consumer facing campaigns

Experience in implementing digital and social marketing campaigns

Graphic Artist

Bachelor’s Degree with 3 years of experience or equivalent combination

Medical Device / Medical Products experience a plus

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Strong project management skills

Able to coordinate multiple projects and meet deadlines

Must have excellent verbal and written communication skills

Proficient with graphic design, video editing and website software

REGULATORY, QUALITY & CLINICAL AFFAIRS

Clinical Complaints Manager - RN

BA/BS in Nursing is required

5+ years work experience in a clinical or health care field

Previous training experience in an outpatient clinical setting is an asset

Minimum 2 years post market complaint handling experience in FDA and ISO regulated

environment desired

Project management and lead/supervisory experience

Demonstrated proficiency in MS Office applications, including Outlook, Word, Excel, and PowerPoint

MANUFACTURING, SUPPLY CHAIN, OPERATIONS & R&D ENGINEERING

Director of Operations – (based in S. CA)

Bachelor’s Degree in Business Management. Master’s degree in a relevant technical discipline or

equivalent is preferred.

10+ years’ experience in a progressive Lean manufacturing operation.

Leadership experience with a complex, diverse, and dynamic manufacturing environment that is

constantly growing.

Experience in a regulated industry a plus.

Experience in managing a vertically integrated facility with all business aspects from formulations

to the shipping of the product, as well as knowledge of ERP systems and inventory management

(logistics), theory of constraints, S&OP and Six Sigma.

Staff R&D Engineer

B.S. degree in engineering or relevant technical field (mechanical or biomedical preferred).

5+ years’ of experience in the medical device industry (interventional, neuro or cardiovascular)

Excellent interpersonal and communication skills with good leadership abilities.

Excellent analytical and problem solving skills.

Strong technical capabilities and project management capability to develop aspect of assigned

projects on time and within budget.

Principal Catheter Engineer (based in S. CA.)

Bachelor’s degree in Mechanical, Process, Biomedical, or Plastics Engineering

Minimum 5 years’ related experience and/or training in the medical device industry catheter design

and manufacturing.

Experienced in Process Validation (IQ/OQ/PQ).

Project Management using MS Project.

Experience in development and execution 510k testing for PTA and PTCA devices is a plus.

Understanding of polymers, extrusion, or blow molding is a plus.

Hands on experience with interventional device manufacturing such as thermal and adhesive

bonding, pleating, wrapping, marker band swaging, extrusion, and balloon blowing.

Utilize DMAIC and Six Sigma tools to improve processes and address root cause failures.

Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to

improve quality, labor efficiency, and throughput.

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

Jobs That Crossed My Desk Through Jan. 24, 2016

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

Wirth & Associates is an Executive Search Firm. Nancy Cody

Wirth & Associates

[email protected]

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Sr. Manager Production & Inventory Control

The Senior Manager of Production and Inventory Control is responsible for maintaining the site master

plan that aligns commercial and non- commercial requirements across the site resources providing

resource and material requirements, milestone due dates, and downstream scheduled supply of

manufactured goods.

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

Senior Civil/Environmental Engineer

Professional Civil, Geotechnical, or Environmental Engineer with experience in solid waste management,

landfills, land development

issues, environmental consulting, and groundwater protection.

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

Project Manager/Project Engineer

Project Manager/Project Engineer, you will to take a prominent role in the design, permitting and

construction of biogas and

landfill gas systems, solid waste handling and disposal facilities as well as other environmental projects.

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

Environmental Scientist / Compliance Project Manager

Utilizing your entire arsenal of skills and talents, you will compare field site data to regulatory standards

for compliance, read

regulations, permit conditions, write compliance reports and tabulate data, and work on permit

applications.

Senior Vice President, Global Head of Product Development - CA

Direct all aspects of global animal health product development - both for products in development and

those already in the market

Effectively establish the strategic direction for product development and management, and define the

framework and process for

strategy and initiative development.

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

Lead Formulation Scientist

CA

Develop, plan and execute formulation projects for animal health products

Senior Veterinarian

CA

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

Sr. Manager, Environmental Health and Safety and Security - 11316-IP

Monitors and inspects lab and production areas for compliance with CA Fire Code, OSHA, DTSC, and

BAAQMD regulations.

Serves as the contact person for all appropriate government agencies.

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

Manager, DEA Compliance - 11416-IP

This position is responsible for DEA compliance management.

Manager, Method Validation

Method Validation is responsible for providing the day to day leadership and analytical chemistry and

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regulatory guidance to the

Method Validation and Method Transfer sections of R&D Analytical Sciences.

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

Director, CMC Regulatory Affairs

CA

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

Clinical Trial Manager

CA

Comprehensive oversight of operational aspects of assigned clinical trials.

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

Data Manager/Database Designer

CA

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

Lead - Compressing - 2nd Shift and 3rd Shift

Midwest

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

Validation Engineer

TX

Pharma experience 3-6 years, equipment qualification, requalification work,

protocol/acceptance report writing. Troubleshooting. Oral solid and liquid products

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

R&D (formulator). Pharmaceuticals

TX

Solids and Liquids

Manufacturing facilities, generic pharmaceuticals.

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

ob ID Employer Position Description Requirements Location Contact Post

Date

Details>>

Nano

Precision

Medical

Research

Associate

Company Description Nano

Precision Medical is an early-stage

start-up company located in

Emeryville, CA. We are developing

a small, implantable device to

improve treatment for people

suffering from chronic diseases by

providing sustained medication

levels over several months without

the need for injections. Job

description: We are looking for a

Research Associate, preferably with

2-5 years of work experience in the

pharmaceutical industry. This

position will be responsible for

planning, execution and evaluation

of peptide formulation studies,

Necessary skills: • At

least a Bachelor’s

Degree in one of the

following areas:

Bioengineering,

Chemistry,

Biochemistry, Chemical

Engineering, Materials

Science, Biology, •

Experience with

pharmaceutical

chemistry and/or

formulation • Basic

chemical lab and

analytical skills •

Comfortable in the lab

and functional with

Emeryville

Ca 94608

https://nano-precision-

medical.workable.com/jobs/187903 1/18/2016

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including release rate and stability

studies. Sound scientific reasoning

and diligent lab skills are

requirements. Familiarity with

analytical tools (HPLC, UV, MS,

SEC) and controlled drug delivery

concepts are highly preferred.

Please apply by 1/31/16 using the

following URL: https://nano-

precision-

medical.workable.com/jobs/187903

minimal oversight •

Excellent attention to

detail • Good

communication and

documentation •

Flexibility • Comfortable

working in a close-knit

team • Experience using

Microsoft Excel, Word,

Powerpoint, etc • Must

be comfortable

performing some

repetitive tasks • Must

be legally authorized to

work in the United

States Preferred

skills/qualifications: •

2+ years of

chemical/pharmaceutical

lab experience •

Experience handling

millimeter-scale objects

with hands, forceps, etc

• Experience with HPLC,

MS, UV, Fluorescence,

Dissolution • Experience

with lab work in industry

is beneficial • Master’s

degree

Details>>

Nano

Precision

Medical

Lab

Manager

Company Description Nano

Precision Medical is an early-stage

start-up company located in

Emeryville, CA. We are developing

a small, implantable device to

improve treatment for people

suffering from chronic diseases by

providing sustained medication

levels over several months without

the need for injections. Job

description: We are looking for a

Lab Manager to manage the daily

operations of our drug and

chemistry lab. This person will be

responsible for the management

and logistics of lab operations, as

well as for assistance with well-

established chemical procedures

and pharmaceutical operations. 5 -

10 years of experience working in a

chemical or pharmaceutical lab

environment is preferred for this

position. Responsibilities Lab

management • Order and maintain

laboratory equipment • Order

chemicals and maintain chemical

inventory • Maintain EH&S

documentation and proper waste

Qualifications •

Bachelor's / Associate

degree in chemistry or

related field, or high

school diploma with

additional vocational

training

certification/diploma • 5

- 10 years of work

experience, industry

experience preferred •

Must be legally

authorized to work in

the United States

Necessary skills: • Self-

starter with ability to

work autonomously •

Must have the ability to

work in the lab with

minimal oversight •

Excellent attention to

detail • Good

communication and

documentation skills •

Basic lab skills, including

pipetting, preparation of

buffers and reagent

solutions, operation of

Emeryville

Ca 94608

https://nano-precision-

medical.workable.com/jobs/188525 1/18/2016

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disposal • Maintain general

laboratory inventory and

management Study support •

Perform parts of experimental

studies in compliance with

established procedures • Maintain

solution and reagent supplies for

ongoing studies This position is to

be filled ASAP. Please apply using

the following URL: https://nano-

precision-

medical.workable.com/jobs/188525

basic lab equipment,

etc. • Flexibility • Must

be comfortable

performing some

repetitive tasks • Basic

computer skills and

efficiency in Microsoft

Office • Comfortable

working in a close-knit

team Preferred skills: •

Experience with

pharmaceutical

chemistry and/or

formulation • Experience

handling millimeter-

scale objects with

hands, forceps, etc. •

Experience with

pharmaceutical solid

dosage form

technologies, tableting,

extrusion, granulation,

etc.

Ronald H. Coelyn

E-mail: [email protected]

Phone: 214-592-0275

web: http://www.coelyngroup.com

Our Firm is currently working on several executive search projects for healthcare and life sciences

industry clients. We would value your help in identifying some exceptional candidates for one very special client in particular.

This client is an early stage medical device Company and was one of a few companies chosen by the

FDA to participate in an Early Feasibility Study Investigational Device Exemption ("IDE") Pilot Program for the interventional cardiology technology it has developed.

The studies are open-label, controlled, multi-center, first-in-human clinical trials being conducted at

several centers in the United States and in the EU. As the technology is highly proprietary nothing more can be provided at this time.

The intent of FDA at this time is to foster early-stage development of medical devices within the United

States to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable.

The Company is pre-revenue at this time.

The company is located in Mountain View, California and the Chief Operating Officer must live in the

area today or be willing to relocate.

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CHIEF OPERATING OFFICER

The Chief Operating Officer ("COO") will be a person that can help lead growth and expansion being

responsible for reviewing and then taking ownership of an established Strategic Business Plan ("SBP").

He/she will ensure that financial, operational, quality, business development, compliance, strategic development, and staff management and leadership objectives are achieved.

As the COO the successful candidate will be responsible for all aspects of the Company's operations as

described above, and all employees (with the sole exception of the President & Chief Executive Officer)

will report, directly or indirectly, to the COO. He/she will in turn report to the President & Chief

Executive Officer and be responsible for working with him, the Board of Directors, and the senior management team.

Above all, candidates must be highly entrepreneurial and able to manage growth with limited

administrative support staff. Candidates must also have considerable experience with interventional cardiology products.

This project may appear to be a repeat of a COO project we commenced last fall, and it is. In the

interim, the Company was distracted by significant progress with the FDA and completion of another round of financing.

We are now ready to refocus.

We are seeking individuals with impeccable personal and professional reputations and unquestioned integrity; people who are relentless in the pursuit of lofty goals.

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

Email Susana Abreu-Ribeiro: [email protected]

Research Associate--Cairn Biosciences

Cairn Biosciences’ next-generation live cell assays guide the discovery of new medicines. Our

proprietary screening assays navigate the landscape of cellular targets and processes through real-time

visualization of compound-target interactions and dynamic phenotypic changes. Our library of rapidly

customizable multicolor cellular models enables turnkey implementation of robust multicomponent live

cell assays that inform and accelerate drug discovery.

We are seeking a highly motivated and goal-oriented Research Associate with demonstrated expertise

in molecular and cell biology to join our team in San Francisco (Mission Bay). Cairn Biosciences fosters a

dynamic start-up environment where self-driven, enthusiastic employees thrive. The successful

candidate will be a highly collaborative, resourceful and effective team-player who is enthusiastic to

tackle challenging scientific and technical problems with novel approaches in the lab.

Key responsibilities

• Maintain mammalian cell cultures

• Mammalian stable cell line generation

• Design and molecular cloning of reporter constructs

• Design and optimization of lab protocols

• Timely and transparent communication of project progress to the team

• Lab management and organization

• Maintain inventories

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Cairn Biosciences is an Equal Opportunity Employer offering a competitive salary and benefits package.

Please send your resume to [email protected] with "Lab Manager Application" in the

subject line. This position is to be filled ASAP

Lab Manager--Nano Precision Medical

Company Description

Nano Precision Medical is an early-stage start-up company located in Emeryville, CA. We are

developing a small, implantable device to improve treatment for people suffering from chronic diseases

by providing sustained medication levels over several months without the need for injections.

Job description:

We are looking for a Lab Manager to manage the daily operations of our drug and chemistry lab. This

person will be responsible for the management and logistics of lab operations, as well as for assistance

with well-established chemical procedures and pharmaceutical operations. 5 - 10 years of experience

working in a chemical or pharmaceutical lab environment is preferred for this position.

Responsibilities

Lab management

• Order and maintain laboratory equipment

• Order chemicals and maintain chemical inventory

• Maintain EH&S documentation and proper waste disposal

• Maintain general laboratory inventory and management

Study support

• Perform parts of experimental studies in compliance with established procedures

• Maintain solution and reagent supplies for ongoing studies

Qualifications

• Bachelor's / Associate degree in chemistry or related field, or high school diploma with additional

vocational training certification/diploma

• 5 - 10 years of work experience, industry experience preferred

• Must be legally authorized to work in the United States

Necessary skills:

• Self-starter with ability to work autonomously

• Must have the ability to work in the lab with minimal oversight

• Excellent attention to detail

• Good communication and documentation skills

• Basic lab skills, including pipetting, preparation of buffers and reagent solutions, operation of basic

lab equipment, etc.

• Flexibility

• Must be comfortable performing some repetitive tasks

• Basic computer skills and efficiency in Microsoft Office

• Comfortable working in a close-knit team

Preferred skills:

• Experience with pharmaceutical chemistry and/or formulation

• Experience handling millimeter-scale objects with hands, forceps, etc.

• Experience with pharmaceutical solid dosage form technologies, tableting, extrusion, granulation,

etc..

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

Please send your resume to [email protected] with "Research Associate Application"

in the subject line by 1/31/16.

Research Associate--Nano Precision Medical

Company Description

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Nano Precision Medical is an early-stage start-up company located in Emeryville, CA. We are

developing a small, implantable device to improve treatment for people suffering from chronic diseases

by providing sustained medication levels over several months without the need for injections.

Job description:

We are looking for a Research Associate, preferably with 2-5 years of work experience in the

pharmaceutical industry. This position will be responsible for planning, execution and evaluation of

peptide formulation studies, including release rate and stability studies. Sound scientific reasoning and

diligent lab skills are requirements. Familiarity with analytical tools (HPLC, UV, MS, SEC) and controlled

drug delivery concepts are highly preferred.

Necessary skills:

• At least a Bachelor’s Degree in one of the following areas: Bioengineering, Chemistry, Biochemistry,

Chemical Engineering, Materials Science, Biology,

• Experience with pharmaceutical chemistry and/or formulation

• Basic chemical lab and analytical skills

• Comfortable in the lab and functional with minimal oversight

• Excellent attention to detail

• Good communication and documentation

• Flexibility

• Comfortable working in a close-knit team

• Experience using Microsoft Excel, Word, Powerpoint, etc

• Must be comfortable performing some repetitive tasks

• Must be legally authorized to work in the United States

Preferred skills/qualifications:

• 2+ years of chemical/pharmaceutical lab experience

• Experience handling millimeter-scale objects with hands, forceps, etc

• Experience with HPLC, MS, UV, Fluorescence, Dissolution

• Experience with lab work in industry is beneficial

• Master’s degree

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

Company Address

39655 Eureka Drive

Newark, CA 94560-4806

Contact

Tim Grammer

[email protected]

DeviceFarm, Inc. seeking Electrical, Biomedical or Mechanical Engineer for Post-doctoral position

Project Overview

We are developing a novel medical device to treat onychomycosis or fungal nail. The major goals of our

project are to develop a clinical prototype instrument, perform engineering tests and analysis that verify

its performance on established in vitro nail models and do the initial safety evaluation and risk

management tasks required before clinical trials can begin. Specifically, this project would utilize

engineering design and development skills to modify and optimize our non-thermal plasma instrument

and then perform laboratory bench testing to determine the modification's success in a rapid

development cycle.

Job Description

We are building a medical device to cure fungal nail infections. 10% of the world is infected, so if you

want to work on a big, important medical problem, this is about as big as you'll get.

We are on track to do our first clinical trial in early 2016 with our first prototype that will provide proof

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2/7/2016 14

of concept that the device technology works for real patients.

Your role, as a mechanical or electrical engineer, will be to work with and help us iterate and improve

our device design for "version 2.0" such as:

• Finding ways to reduce the size of the device

• Finding ways to improve the effectiveness of the treatment (example: changing the geometry of

how the device interfaces with the patient's foot)

• Improving the human factors of the device (e.g., comfort for the patient)

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

Email Steve Roon: [email protected]

Cancer Biologist for Life Science Startup – SageMedic

Early stage cancer diagnostic startup, has an opening for a PhD, postdoc, or fellow in cell biology or

biomedical engineering. If you join the team you will be expected to leverage all of your qualities: the

creativity required to find new ways of getting the job done; the reliability in execution needed to be

thorough, detail-oriented and meticulous in fully documenting your work; and the innovation essential

to thriving in a startup that requires a constant supply of new ideas or new ways of approaching

obstacles.

Required skills are experience in at least one of the two categories

• Cell-based assays, 3D culture of primary tissues, and lab automation

• Confocal microscopy on live tissue, ranging from staining, data acquisition to data analysis.

We are less concerned about degrees than confidence in skills and experience, commitment and

purpose. Our startup is currently self-funded, so compensation will be partly cash partly equity until we

have obtained external funding. If you are up for the challenge, submit a resume with your LinkedIn

profile and a brief personalized cover letter where you elaborate about your skills in the two categories

mentioned above.

Our startups and affiliates are hiring. See selected openings below. We maintain current job listings at

http://jobs.qb3.org/?mc_cid=2677d0cffd&mc_eid=[UNIQID].

If you would like to post an opening on our website, please contact us with your name, email address,

and company name. We will forward this to VentureLoop, the third party who manages our job listings.

They will contact you and set you up with access to a free account so you can manage your own posting

details.

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

Jobs That Crossed My Desk Through Jan. 17, 2016

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

*

Nancy Cody

Wirth & Associates

[email protected]

Senior Civil/Environmental Engineer

Professional Civil, Geotechnical, or Environmental Engineer with experience in solid waste management,

landfills, land development issues, environmental consulting, and groundwater protection.

___________________________________________________________________

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Project Manager/Project Engineer

Project Manager/Project Engineer, you will to take a prominent role in the design, permitting and

construction of biogas and landfill gas systems, solid waste handling and disposal facilities as well as other

environmental projects.

___________________________________________________________________

Environmental Scientist / Compliance Project Manager

Utilizing your entire arsenal of skills and talents, you will compare field site data to regulatory standards

for compliance, read regulations, permit conditions, write compliance reports and tabulate data, and work

on permit applications.

___________________________________________________________________

Senior Director Supply Chain

The Senior Director Supply Chain is responsible for managing the drug product supply chain for clinical

and commercial distribution.

___________________________________________________________________

Sr. Manager, Environmental Health and Safety and Security - 11316-IP

Monitors and inspects lab and production areas for compliance with CA Fire Code, OSHA, DTSC, and

BAAQMD regulations.

Serves as the contact person for all appropriate government agencies.

___________________________________________________________________

Manager, DEA Compliance - 11416-IP

This position is responsible for DEA compliance management.

___________________________________________________________________

Lead Formulation Scientist

CA

Develop, plan and execute formulation projects for animal health products

___________________________________________________________________

Senior Veterinarian

CA

___________________________________________________________________

Manager, Method Validation

Method Validation is responsible for providing the day to day leadership and analytical chemistry and

regulatory guidance to the Method Validation and Method Transfer sections of R&D Analytical Sciences.

___________________________________________________________________

Director, CMC Regulatory Affairs

CA

___________________________________________________________________

Clinical Trial Manager

CA

Comprehensive oversight of operational aspects of assigned clinical trials.

___________________________________________________________________

Data Manager/Database Designer

CA

___________________________________________________________________

Senior Vice President, Global Head of Product Development - CA

• Direct all aspects of global animal health product development – both for products in development and

those already in the market

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• Effectively establish the strategic direction for product development and management, and define the

framework and process for strategy and initiative development.

Lead - Compressing - 2nd Shift and 3rd Shift

Midwest

___________________________________________________________________

Validation Engineer

TX

Pharma experience 3-6 years, equipment qualification, requalification work,

protocol/acceptance report writing. Troubleshooting. Oral solid and liquid products

R&D (formulator). Pharmaceuticals

TX

Solids and Liquids

___________________________________________________________________

Manufacturing facilities, generic pharmaceuticals.Sr. Director of Operations

NE

The purpose of the Sr. Director of Operations position is to manage, plan, direct, and coordinate the

general operations of the solid dose, generics site.

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

Jobs that Crossed My Desk Through Dec. 13, 2015

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

Contact: Darshana Nadkami

More details posted in JOBS category at www.darshanavnadkarni.wordpress.com .

Here are my current openings.

* Research Associate: with MS or BS in Molecular Biology, Biochemistry or related plus solid track record

in bioanalytical assays & proficiency in HPLC, Elisa immunoassays, luminescence assays, fluorescence

assays or related.

* CLIA Lab Manager: with experience & valid licence to perform high complexity testing

* Director of Quality Engineering: BS in engineering required & drug delivery experience a huge plus.

* Director of Manufacturing

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

Contact:

Angel Romero

President

Global Recruiters of West Palm Beach

[email protected]

561-422-5150

National Sales Training Leader - CA - #2094

A leader in electrophoresis, protein assays, gel image analysis, quality controls, diabetes monitoring,

autoimmune testing, blood typing, and BSE and chronic wasting disease testing is searching for a National

Sales Training Leader.

Key Duties, Activities and Responsibilities:

This position will be responsible for designing training strategy and associated curriculum for Commercial

Sales, Customer Operations and Customers. This position will lead, supervise, and coach the commercial

training team in developing and delivering an applicable and an effective curriculum focusing on selling

skills, product knowledge, territory organization, product repair & maintenance and customer training.

This position will provide affected participants a consistent learning experience for the achievement of

global commercial goals.

Additionally, the position will function as an internal consultant to the Commercial management team, by

assessing developmental gaps and learning needs of the workforce and determining appropriate, and

measurable, training initiatives. This position will include the management of existing programs and the

design/creation of new programs and training materials, to support the company’s growth and success.

Position Description:

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Hire, develop and manage trainers. Set clear job performance expectations and providing

feedback and measurement against those standards;

Drive and implement the learning and development vision and strategy, coordinating across the

organization to identify and prioritize learning needs and collaborating with others to ensure

effective implementation.

Responsibilities include, but not limited to:

1. Managing all aspects of existing sales training programs and the design/creation of new

programs and training materials.

2. Collaborating with sales product marketing and regional marketing to develop training

curriculum standards and guidelines for key product launches; National meetings; teleconferences

and other trainings as needed.

3. Collaborating with sales management to increase sales force effectiveness by conducting

“ridealongs”, identifying sales training/development opportunities and sharing “best practices”

across the sales organization.

4. Oversee the design and development of both customer and USSD Technical staff training course

curriculum and supporting material. Also updating and revision controlling the training material to

reflect changes in instrument system design, operation, software releases and assays, etc.

5. Oversee the design, development and ongoing maintenance of customer service training for new

and existing customer service employees

6. Manage regulatory approval of curriculum and ensure compliance.

· Establish strong relationships and meet regularly with sales, marketing, customer

operations, regulatory and any other strategic business partner to understand needs and

opportunities. Work cross-functionally with commercial team members to develop training to

support the tactical strategy and execute training programs and materials that support

achievement of commercial team’s business goals;

· Participates with other senior managers to implement strategic plans and objectives. Has

input into the decisions on administrative or operational matters and ensures operations’

effective achievement of objectives;

· Design and analyze assessments to identify skills and knowledge gaps on learning goals.

Evaluate the effectiveness of course content and make necessary adjustments to materials and

delivery methods. Conduct routine needs analysis and provide input to development and

implementation of annual training plans;

· Design and develop learning solutions focused on professional development and selling skills

(negotiation, Miller-Heiman etc.); and ad hoc curriculum relevant to critical business initiatives

and other departmental/functional needs;

· Collaborate with ODBP in preparing curriculum/OJT for ‘bench’ within the organization to

ensure that a ready pool of talent is available and trained to fill future openings;

· Applying project management techniques to ensure projects are completed on time and

within established budgets; and

· Establish and manage relationships with 3rd party training providers and software vendors

(vendor management).

Work Experience, Skills and Education Required:

· Must be a good communicator, have project management skills, good teaching and motivating

skills.

· Basic to advanced computer skills a must.

· Proficient in Microsoft Office, Adobe Reader, and Webinar technologies

· Ability to translate business needs into effective strategies and execute against those strategies

by defining training/organizational system needs, developing, implementing, evaluating and

monitoring curriculum/interventions to ensure continued effectiveness.

· Strong interpersonal skills including listening, negotiating, oral and written communication skills

along with the ability to interact with diverse personalities while exercising tact and flexibility.

· Ability to identify and analyze problems, exercise independent judgment, resourcefully innovate,

recommend and lead effective courses of action.

· Ability to organize, prioritize, coordinate, implement and manage complex or multiple projects

and tasks in a rapidly changing, fast paced environment in conjunction with day-to-day activities.

· Ability to appropriately evaluate skills, identify development opportunities and provide effective

coaching.

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· Excellent presentation and platform skills and up to date knowledge of contemporary training

modalities

· Clear understanding of adult learning theory, principles of communication

Director, International Sales – CA - #2138

A leader in rapid forensic and human DNA identification technology is searching for a Director,

International Sales in the California Bay Area.

Key Duties, Activities and Responsibilities:

·

· Responsible for aggressive sales growth, business development, and strategic planning.

·

· Develop and execute strategy to strengthen wallet share and revenue growth with existing

international customer base, including EMEA, Asia/PAC

· Identify key geographic areas with greatest growth opportunity and develop go-to market

plans, either distribution or direct sales

· Manage a team of sales professionals to support sales as needed

· Contribute to sales projections and resources required to obtain sales objective

· Create and implement strategic sales plans in the international arena

· Develop and maintain strong customer relations and oversee resolution of all customer issues

promptly and effectively

Facilitates resolution of customer issues by demonstrating a strong broad base of knowledge in

business processes. The firms products and domain expertise

Work with Marketing team to identify and document target customer needs and product

configuration implementation strategies

Heavy engagement with Technical Account Managers (Applications) to ensure robust cartridge pull

through

Work Experience, Skills and Education Required:

· Must have strong selling and market development abilities

· 5-10 years sales management experience, including international markets in biometric space

· Capital Equipment sales experience with large ticket (>$1M) items

· Must have exceptional interpersonal and communication skills

· Must be strong negotiator and closer

· Fluency in foreign languages a plus

· Proven skills in prospecting, planning, negotiating and closing business deals

· Well developed communication skills with sensitivity to time zones, cultural differences, etc.

Superior skills in Microsoft Office (Outlook, Word, Excel and Power Point)

Excellent attention to detail

Travel 50%+

Bachelor’s degree preferred, or equivalent combination of education and experience

Five years plus of experience directly managing order processing/customer service

Experience with SalesForce

A working knowledge of continuous improvement

Medical Director – Regenerative Medicine – CA - #2035

A leading biotechnology company in the emerging field of regenerative medicine is searching for a Medical

Director, Regenerative Medicine

Key Duties, Activities and Responsibilities:

The Medical Director, Regenerative Medicine will be responsible for all activities supporting clinical trials of

the firms’ cell-based therapies. Specifically, this person will be responsible for:

· Designing, implementing, and monitoring clinical studies of the firms cell-based therapies

· Development of protocols, sample informed consent templates, Investigator Brochures and case

report forms for Phase 1 to 3 clinical trials

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2/7/2016 19

· Oversight and management of the firms clinical operations

· Co-Lead joint clinical/product development team to develop cell delivery devices/strategies suitable

for pivotal trials and commercialization

· Act as the Clinical Lead for Phase 1-3 trials of the firms cell-based therapies for spinal cord injury

and other neurodegenerative diseases

· Provide clinical development support, as needed, for the firms cell-based therapies in oncology

· Function as Medical Monitor to ensure that clinical trials are conducted according to the

Investigational Plan, applicable regulatory requirements, Good Clinical Practice, and internal SOPs

· Responsible for ensuring study protocols, amendments, specific sections of study manuals and

other documents meet internal and external requirements

· Responsible for clinical study reports, presentations, and clinical advisory panels

· Oversee data management, biostatistics, and clinical trial recruitment/patient referral functions

· Recruits/screens/selects competent investigators; leads investigators' meetings

· Monitors data for safety and efficacy trends by reviewing clinical data; and writes clinical reports

upon completion or termination of studies (in cooperation with statistical staff)

· Establishes and maintains relationships with alliance partners, external companies, investigators

and opinion leaders to optimize performance on clinical trial activities

· Prepares manuscripts for technical journals and makes presentations at scientific meetings

· Support surgeon training required for current clinical trials

· As required, work with CROs and other vendors to execute clinical development activities

· Plan timetables and budgets for clinical development activities

· Work with business development to identify potential partners and execute strategic alliances

· Work with legal team to file and prosecute intellectual property and to execute freedom to operate

searches

Work Experience, Skills and Education Required:

· The candidate must be a goal oriented individual with a hands-on leadership style to manage a

hard-working, enthusiastic group of clin ops personnel, scientists and engineers to develop the firms

cell-based products for clinical testing and eventual commercialization.

· The candidate must have an M.D. with at least 5-10 years of clinical research/development

experience. Experience in the areas of biological/cell therapy and/or CNS indications strongly

preferred. Experience with medical devices and/or combination products is a plus.

· The candidate must have and maintain a valid California Medical License

· The candidate must demonstrate a strong initiative and resourcefulness to drive clinical

development activities to meet corporate goals without compromising patient safety.

· Prior experience in preparation/submission of clinical sections for IND/BLA submissions preferred.

· The candidate must have strong organizational and interpersonal skills along with well-developed

oral and written communication capabilities. The candidate must be able to interact with staff,

scientists, physicians, vendors, and business development professionals to accomplish goals and meet

company timelines.

· The candidate must have strong supervisory skills and be able to coordinate/advance project

activities.

· Able to travel within and outside of the USA as needed. Estimated travel time is 20% on average,

but will fluctuate according to study needs.

· The candidate must thrive in a team-oriented entrepreneurial environment.

Sr. Product Manager – CA - #2096

A leading global medical technology company that develops, manufactures and sells medical molecular

diagnostics devices, instrument systems and reagents is seeking a Sr. Product Manager in Southern

California.

Key Duties, Activities and Responsibilities:

Manage the promotion, pricing, menu and distribution channels of Diagnostics products both domestically

and internationally to achieve established financial and strategic goals. Supports applicable regulations

including ISO, Local, State, and/or Federal requirements.

· Develop marketing plans that support the achievement of both financial and strategic goals of

the organization.

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2/7/2016 20

· Develop, communicate and implement pricing policies and guidelines that maximize profits and

sales volume.

· Provide accurate product forecasts to production/operations in an effort to avoid backorders

and/or excess inventory.

· Serve as a technical expert to the field sales organization on Diagnostic products and related

competitive products.

· Assist Technical Services with the troubleshooting of product complaints and service issues.

· Develop training materials, educational materials and training presentations for the field sales

organization.

· Build and maintain an up-to-date comprehensive file on all key competitor’s and products.

· Serve as the point person for the field sales organization concerning arrangements for field-

based diagnostic product presentations, speaking engagements, and other promotional

opportunities.

· Work with Marketing Manager to establish a system to effectively launch new diagnostic

products.

· Oversee and assist in the arrangement of product evaluations.

· Take an active role in new product identification and development; Work closely with Research

and Development to seek out and to identify opportunities to expand product offering; oversee the

development of new diagnostic products.

· Serve as expert on all competitive products and systems related to Diagnostics’ menu.

· Visit key clients and distributors to promote long term relationships and networking contacts.

· Perform work within published expense and budget 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. Cooperate in all safety or health-related programs and assist in

solving safety and health problems as necessary. Violations of safety directives and procedures will

be handled in accordance with the established Company disciplinary process.

· Perform other duties as assigned.

Work Experience, Skills and Education Required:

· B.S. or B.A. degree-MBA preferred.

· Minimum of 2-3 years of marketing experience in diagnostic or reference laboratory industry.

Minimum of 2-3 years sales experience in diagnostic or reference laboratory industry.

· Strong infectious disease technical background strongly preferred.

· Demonstrated ability to discuss new product concepts and industry trends with Ph.D. and MD

level contacts.

· Knowledge of the infectious disease marketplace-knowledge of key industry players,

publications, conventions, etc.

· Ability to read, analyze, and interpret general business periodicals, professional journals,

technical procedures, or governmental regulations.

· Ability to write reports, business correspondence, and procedure manuals.

· Excellent public speaking and written communications skills.

· Strong financial and analytical skills; close attention to detail.

· Ability to interpret a variety of instructions furnished in written, oral, diagram form.

· Ability to deal with problems and make sound business decisions

Manager, Marketing Communications – CA - #2097

A leading global medical technology company that develops, manufactures and sells medical molecular

diagnostics devices, instrument systems and reagents is seeking a Manager, Marketing Communications,

in Southern California

Key Duties, Activities and Responsibilities:

Manage the promotion of the firms Diagnostic products to ensure thorough execution of short and long-

term strategic and tactical marketing plans in order to exceed sales plan. Supports applicable regulations

including ISO, Local, State, and/or Federal requirements.

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· Successfully launch new testing services and new diagnostic products, develop internal and

external notification, develop training materials for field sales organization and client labs as

required.

· Develop advertising plan to include ad development and placement schedule to maximize

exposure to target market and quality lead generation. Track leads and lead quality.

· Draft promotional advertising, brochures and flyers for new Diagnostic products and update

appropriate marketing tools, including catalog and technical sheets.

· Establish annual budgets for personal expenses and marketing communications materials.

Achieve stated marketing objectives within budget.

· Identify industry trade shows and recommend level of participation. Attend key trade shows and

scientific seminars in order to keep current with scientific developments and emerging market

needs.

· Develop and implement an annual survey of clients to measure satisfaction with our services.

Analyze survey results and recommend action items to improve the firms image.

· Coordinate graphic design and printing vendors for creation of marketing materials.

· Manage the development and/or maintenance of marketing communication tools to include

graphics, booths, flyers, giveaways, catalog, technical sheets, power point presentations, etc to

increase market knowledge and awareness and to promote the sale of Diagnostic products.

· Manage website to meet shifting market expectations. Monitor activity on a regular basis.

· Keep information current.

· Develop and manage PR opportunities to include posters, presentations, speaking engagements,

press releases, editorials in industry journals, sponsorships and joint marketing to maximize

exposure to market.

· Design and manage corporate identity, including logo, in all marketing materials in order to

present a consistent corporate image of quality and build visual recognition.

· Ongoing review of marketing processes and procedures to improve accuracy and efficiency.

· Visit key customers to promote long term relationships and networking contacts.

· Travel with field sales organization on a routine basis in order to assist in the acquisition of new

business and to develop first hand experience of current needs and opportunities.

· 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.

Work Experience, Skills and Education Required:

· Bachelor's degree (B. A.) from four-year college or university

· Three to five years related experience and/or training; or equivalent combination of education

and experience.

· Ability to read, analyze, and interpret general business periodicals, professional journals,

technical procedures, or governmental regulations.

· Ability to write reports, business correspondence, and procedure manuals.

· Ability to effectively present information and respond to questions from groups of managers,

clients, customers, and the general public.

· Ability to calculate figures and amounts such as discounts, interest, commissions, proportions,

percentages, area, circumference, and volume.

· Ability to apply concepts of basic algebra and geometry.

· Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

or diagram form.

· Ability to deal with problems involving several concrete variables in standardized situations.

Senior Systems Engineer - #1810

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2/7/2016 22

A major global screening, molecular diagnostics and Biotech Company that manufactures and markets

blood diagnostics and screening instrumentation, reagents and software systems is searching for an

Senior Systems Engineer.

Key Duties, Activities and Responsibilities:

• Lead development of IVD systems, from requirements through design and implementation, through

validation and to customers.

• Define the architecting of systems solutions.

• Contribute to the drafting and review of development agreements with outside partners and vendors.

• Oversee outside partners and vendors work and progress towards developing IVD system products,

including prototype testing, defect reviews, design reviews, V&V

• Work with Global Marketing in the development of customer requirements, and develops product

requirements using requirement management methodologies, including change management.

• Work with internal stakeholders to facilitate the collection of business and regulatory requirements.

Ensure alignment of customer and business needs.

• Develop system level product requirements and component requirement documents.

• Define and prepare a schedule of development tasks.

• Mentor others on systems engineering best practices and procedures.

• Conduct patient safety risk management activities according to FDA and ISO regulations.

• Establish product configuration management.

• Plan and perform integration testing. Establish software ad-hoc testing strategy.

• Support verification and validation activities.

• Present and document work product to meet needs of project and business.

Work Experience, Skills and Education Required:

· B.S. Degree in Engineering and/or Science: advanced degree preferred.

· 5+ years of relevant experience developing IVD integrated system based diagnostic products.

· Experience with leading development efforts in a cross functional environment

· Ability to solve complex systems issues and problems

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

· Demonstrated software product development experience, using lifecycle methodologies.

· Strong knowledge of best practices of development under FDA design control.

· Possesses project leadership skills in managing priorities, delegating, and influencing others.

· Ability to convey very complex information in both written and oral form.

· Experience with managing external vendor relationships.

· Ability to influence others, gain acceptance and build consensus.

· Strong written and oral communication skills.

· Knowledge of molecular biology is a plus.

Software System Engineer – CA - #1956

Our Client is a global diagnostics leader in diagnosing infectious diseases and screening blood at major

healthcare institutions worldwide. They are searching for a Software Engineer, System Engineering.

Key Duties, Activities and Responsibilities:

The Software Systems Engineer shall develop and support in-vitro diagnostics (IVD) systems with an

emphasis on testing software based automation scripts. As software engineer in cross-functional project

teams, he or she will responsible for participating in software development, test planning, test

development, and test execution for all vendor supplied and custom built software solutions. The position

focuses on visual basic application development testing currently and later will transition to web based

development and testing effort. The ideal candidate is a self-starter, confident, creative and detail

oriented. The target applications include laboratory data management systems and many others related to

the business

· 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.

· Perform various types of testing including automated testing, data input/output validation, range

testing, navigation, security, data integrity, performance, usability, compatibility with all supported

configurations, and regression testing

· Plan and develop automated testing framework and test suits.

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· 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.

· Recommend changes to match user expectations with application functionality

Work Experience, Skills and Education Required:

· Bachelors Degree

· 3+ years of relevant software engineering test experience with an in depth understanding of

windows and web applications.

· Experience in a cross functional environment.

· Capability to work with aggressive timelines; Flexibility in adjusting schedules to meet

demanding deadlines;

· Able to multi-task; Excellent communication skills; Capability and desire to be a strong team

player in a small to medium sized team that often requires flexibility, creativity and open

mindedness;

· Capable of contributing in the instating of software development best practices.

· Applicants must have critical thinking capability and be able to identify, document, and

reproduce technically oriented problems.

· Experience with different software development processes, QA methodologies, and test

management tools are important.

· Experience with Windows application development and testing is a must.

· Experience in database based software development and testing.

· Experience with test automation development.

· Experience testing medical software and experience with laboratory systems is a plus.

Manager, Marketing Analytics – CA - #2098

A leading global medical technology company that develops, manufactures and sells medical molecular

diagnostics devices, instrument systems and reagents is seeking a Manager, Marketing Analytics in

Southern California

Key Duties, Activities and Responsibilities:

The Manager/Senior Manager, Marketing Analytics is responsible for developing the tools and tactics to

provide business insight and recommend courses of action into competitive activities and development;

Managed Care strategies; and establish Key Performance Indicators (KPI’s) and ongoing performance

measurements of marketing activities.

· Supports the promotion, pricing, menu and distribution channels of Diagnostics products both

domestically and internationally to achieve established financial and strategic goals.

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

Manages competitive intelligence process, and works with field teams to ensure the timely input of

insights into Salesforce.com.

· Reviews competitive press articles, Annual Reports and subscribes to news services to ensure

timely capture of changing market conditions.

· Analyzes inputs and develops monthly competitive update for Commercial team and quarterly

competitive update for Senior Management.

· Builds and maintains an up-to-date comprehensive file on all key competitors and products.

· Tracks performance across various payer segments & plans, and anticipates impact of potential

changes to contracts, policies and pricing. Develops quarterly updates or as needed for

Commercial team.

· Participates in cross-functional marketing analytical projects, including payer segmentation,

account segmentation and targeting.

· Creates payer landscape for targeted accounts.

· Develops, communicates and implements pricing policies and guidelines that maximize profits

and sales volume.

· Develops reporting metrics and monthly dashboard to assess effectiveness of marketing

campaigns, collateral, programs and Social Media relative to budget.

· Supports cross-functional efforts to develop insight and analysis for other commercial databases.

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· Develops marketing plans that support the achievement of both financial and strategic goals of

the organization.

· Serves as expert on all competitive products and systems related to Diagnostics’ menu.

· Serves as the payer landscape expert to the field sales organization on Diagnostic products and

related competitive products.

· Develops training materials, educational materials and training presentations for the field sales

organization.

· Works with Global Marketing Manager to establish a system to effectively launch new diagnostic

products.

· Visits key clients and distributors to promote long term relationships and networking contacts.

· 10-15% travel required.

· Performs work within published expense and budget 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. Cooperate in all safety or health-related programs and assist in

solving safety and health problems as necessary. Violations of safety directives and procedures will

be handled in accordance with the established Company disciplinary process.

· Performs other duties as assigned.

Work Experience, Skills and Education Required:

· B.S. or B.A. degree-MBA preferred.

· Minimum of 5 - 7 years of product marketing and Managed Care marketing experience in

medical device, diagnostics or reference laboratory industry.

· Knowledge of Managed Markets analysis (Managed Care, Government, GPO, IDN) and

appropriate data assets to evaluate managed markets pull-through required.

· Previous diagnostic or laboratory sales experience a plus.

· Diagnostic product launch and commercialization activities supporting launch required.

· Knowledge of Salesforce.com highly desirable.

· Ability to read, analyze, and interpret general business periodicals, professional journals,

technical procedures, or governmental regulations.

· Ability to write reports, business correspondence, and procedure manuals.

· Excellent public speaking and written communications skills.

· Strong financial and analytical skills; close attention to detail.

· Ability to interpret a variety of instructions furnished in written, oral, diagram form.

· Ability to deal with problems and make sound business decisions

Sr. Manager Sales Analytics – CA - #2099

Our client is a global, broad-based health care company devoted to the discovery, development,

manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and

diagnostics. They are searching for a Sr. Manager Sales Analytics in CA.

Key Duties, Activities and Responsibilities:

The primary role of the Sr. Manager of Sales Analytics is to drive the development of sales strategy and to

track the success of its execution. The Senior Manager will take a leadership role in the development,

integration and execution of sales analytical plans for multiple sales channels. He/she will work cross-

functionally with sales management, finance, marketing, forecasting and contracts and pricing. He/she will

present analyses and recommendations concerning sales strategy to senior management as well as launch

and train the sales organization to drive the execution of analytics down to the sales representative level.

· Evaluating Sale Force Effectiveness

· Establish metrics for the evaluation of the sales organization, develop reporting/dashboards and

communicate results to senior management. Manage across both internal and external partners to

develop and maintain sales reporting infrastructure. Drive the evaluation and recommendation of

sales targets, sales force alignment and focus of effort. Identify market opportunities within a

channel as well as across channels. Lead the implementation of sales analytic initiatives through

the use of task forces, educational training and sales leadership coaching.

· Providing Promotion Analytics

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· Increase the understanding of the effectiveness of various promotions conducted by the sales

organization.

· Evaluate the ROI of promotional efforts and provide recommendations to optimize promotional

spend.

· Identify secondary data sources and manage external vendors to conduct advance analyses of

various sales efforts.

· Developing Sales Forecasts

· Work cross functionally between finance, forecasting and sales leadership to develop account

forecasts for each of the sales channels.

· Understand and incorporate key factors such as market demand, category trends, inventory

position and contract terms to drive comprehensive sales forecasts.

· Managing and Developing People

· Responsible for people management and development initiatives including: leading recruitment

efforts, coordination of training for new analysts and ongoing education and development of all

direct reports.

· Business Communications

· Build an understanding of strategic issues, review analytic plans and negotiate priorities with

sales directors across all sales channels.

· Develop insightful summaries of key findings, conclusions and recommendations for senior

management.

· Create and implement training concerning analytics within the sales organization.

· Policies/Compliance

· Adhere to all financial, quality and compliance policies and procedures. Ensure all direct reports

are adhering to the policies and procedures.

Work Experience, Skills and Education Required:

· Bachelors degree in Business, Statistics, Economics or related field required.

· Master's degree in Business, Statistics, Economics or related field preferred.

· 8-10 years analytical experience required preferably in the healthcare or consumer package

goods industry.

· Experience using syndicated, medical claims or longitudinal patient-level data required along

with an understanding of advance analytic techniques used in marking mix modeling, segmentation

analysis, physician and patient targeting and sales force alignment.

· Must exhibit proficiency in the following competencies: adaptability, teamwork, initiative,

innovation, integrity, data analysis, leadership, strategic thinking and communication.

Physician Account Manager – Modesto, CA - #2107

A leader in commercial diagnostic reference laboratory testing, information, and services seeks a Physician

Account Manager in the Modesto, CA area.

Key Duties, Activities and Responsibilities:

The Physician Account Manager is responsible for driving territory growth and profitability through

providing service and the resolution of issues in support of several sales territories; the Physician Account

Manager does not have call point ownership on any of the accounts within the geography; close

cooperation with Physician Account Executives is essential to support the collaborative selling model.

· Manage accounts through ongoing business reviews of service, logistics and supplies to identify

customer needs

· Ensure customer retention by maintaining relationships with current accounts

· Identification and pursuit of up-selling and cross-selling opportunities in cooperation with

Physician Account Executives or “Specialist” Account Executives.

· Partner with physician account executive to resolve account specific service issues

· Partner with Customer Solutions Group to facilitate, prioritize and resolve customer service

issues

· Escalate service issue non-resolution as appropriate

· Leverage all tools and resources (including data, sales portal, target lists; Marketing

Department, Laboratory resources, and regional resources as needed)

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· Provide continuing education to the customer on new technologies and laboratory testing

· Ensure compliance with company polices and government regulations

· Complete all administrative tasks thoroughly and promptly

· Follow up communications with Physician Account Executives and customers

Work Experience, Skills and Education Required:

· Bachelor’s degree in Business, Marketing or Life Sciences.

· Knowledge of Healthcare Industry and general economics of business.

· Ability to develop and sustain strong customer relationships; strong planning and organizational

skills

· Excellent oral and written communication and presentation skills

· Solid PC skill including Microsoft Software.

· Three to four years of experience in sales or with account ownership

· Candidate must have residency in close proximity of territory.

· Must be able to travel to training for extended periods of time (2-3 weeks) in residence.

Product Marketing Manager – CA - #2146

Our client is a global corporation and the unparalleled leader in multiple areas of healthcare; often their

products and services are considered the gold standard. This company’s technical expertise, product

portfolio and global reach are unmatched.

Key Duties, Activities and Responsibilities:

The Product Marketing Manager will be responsible for traditional upstream or strategic marketing

activities working in both the DTP and DTC arenas with emphasis in the digital/mobile space This is a

highly visible role within the company and plays an integral part in driving volume, profit, and share for

our client’s global business.

Responsible for compliance

Collects Global Insights

Define Brand Value Proposition; work with agency partners to develop advertising strategies

Conduct focus groups with doctors and patients prior to converting to execution.

Develops HCP content and tools to support the launches of

Drives alignment between HCP and patient campaigns, and with digital marketing team

Coordinates alignment w/ countries: represents key point of contact for successful campaign

activities

Maintain positive relationships with regulatory, clinical, R&D, etc.

Understands project timeline and how/when to be proactive to keep the project on time & budget

Determines emerging trends in patient marketing

Work Experience, Skills and Education Required:

· Bachelor's degree required, MBA strongly preferred

· 6+ years of experience. A minimum of 4 years in product marketing or advertising focused on

consumers or patients

· Previous experience in marketing, brand management and/or communications agency

experience highly desired

· Must have a track record of successful medical technology/pharma/biotech/CPG

patient/consumer marketing with an understanding of expense budget planning and tracking

· Proven project management skills, performance management, planning, prioritization, objective

setting, meeting management and plan execution

· Experience managing cross-functional teams or work groups

· Demonstrated understanding of pharmaceutical/medical technology regulatory requirements and

impact on development of marketing materials

Global (Coronary) Project Manager RA – CA - #2084

Our client is a global, broad-based health care company devoted to the discovery, development,

manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and

diagnostics. They are searching for a Global (Coronary) Project Manager in CA.

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Key Duties, Activities and Responsibilities:

As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge

of scientific, regulatory and business issues to enable products that are developed, manufactured or

distributed to meet required legislation. The individual has department/group/site level influence and is

generally recognized as an expert and resource within the department. The individual may share

knowledge and expertise with others in support of team activities. The individual may identify data

needed, obtain these data and ensure that they are effectively presented for the registration of products

worldwide.

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

· Strategic Planning:

o Develop new regulatory policies, processes and SOPs and train key personnel on them

o Evaluate regulatory risks of division policies, processes, procedures

o Provide regulatory input to product lifecycle planning

o Monitor regulatory outcomes of initial product concepts and provide input to senior

regulatory management

o Assist in the development of multicountry regulatory strategy and update strategy based

upon regulatory changes

o Assist in regulatory due diligence for potential and new acquisitions

o Utilize technical regulatory skills to propose strategies on complex issues

o Determine submission and approval requirements

o Identify emerging issues

o Monitor trade association positions for impact on company products

o Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and

develop solutions with other members of regulatory and related teams

o Recruit, develop and mentor regulatory professionals

· Premarket:

o Assess the acceptability of quality, preclinical and clinical documentation for submission

filing

o Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical

phases and recommend solutions

o Compile, prepare, review and submit regulatory submission to authorities

o Monitor impact of changing regulations on submission strategies and update internal

stakeholders

o Monitor applications under regulatory review

o Communicate application progress to internal stakeholders

o Monitor and submit applicable reports and ensure appropriate responses are submitted to

regulatory authorities

o Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing

strategies

o Negotiate and interact with regulatory authorities during the development and review

process to ensure submission approval

o Provide strategic input and technical guidance on regulatory requirements to development

teams

o Manage and execute preapproval compliance activities

· Postmarket:

o Oversee processes involved with maintaining annual licenses, registrations, listings and

patent information

o Ensure compliance with product postmarketing approval requirements

o Review and approve advertising and promotional items to ensure regulatory compliance

o Ensure external communications meet regulations

o Develop, implement and manage appropriate SOPs and systems to track and manage

product-associated events

o Actively contribute to the development and functioning of the crisis/issue management

program

o Oversee system to ensure that product safety issues and product-associated events are

reported to regulatory agencies

o Report adverse events to regulatory agencies and internal stakeholders

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o Provide regulatory input for product recalls and recall communications

· Medical writing

· Advertising and promotion

· Labeling

· Controlled substances (e.g. DEA)

· Restricted substances (e.g. REACH)

· Compendial / standards

· Import / export

· Country specific regulatory support

· Individual provides leadership without direct authority (i.e., project leader).

· Individual may provide direction and guidance to exempt and non-exempt personnel who

exercise significant latitude and independence in their assignments.

· Also may mentor other department members.

· Individuals execute and manage technical and scientific regulatory activities.

· Must function independently as a decision-maker on regulatory issues, and must assure that

deadlines are met.

· Effectively communicate, prepare, and negotiate both internally and externally with various

regulatory agencies.

· Properly interpret and apply regulatory requirements.

· Work is performed without appreciable direction and exercises some latitude in determining

technical objectives of assignments.

· Completed work is reviewed from a relatively long- term perspective for desired results.

· Individual is recognized as a discipline expert and resource in regulatory affairs.

· Develops, communicates, and builds consensus for operating goals that are in alignment with

the division.

· Provides leadership by communicating and providing guidance towards achieving department

objectives.

· Interfaces with a variety of management levels on significant matters, often requiring the

coordination of activity across organizational units.

· May lead a cross-functional or cross-divisional project team.

· Provides technical leadership to business units.

· Acts as a mentor to less-experienced staff.

· Exercises judgment independently.

· Creates immediate to long-range plans to carry out objectives established by top management.

· Forecasts project related needs including human and material resources and capital

expenditures.

· Assignments are expressed in the form of objectives

· Makes decisions regarding work processes or operational plans and schedules in order to achieve

the program objectives established by senior management.

· Consequences of erroneous decisions or recommendations would normally include critical delays

and modifications to projects or operations with substantial expenditure of time, human resources,

and funds, and may jeopardize future business activity.

Work Experience, Skills and Education Required:

Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology,

immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is

preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

· 4-5 years experience in a regulated industry (e.g., medical products, nutritionals).

· 2-5 years of experience in regulatory preferred but may consider quality assurance, research

and development/support, scientific affairs, operations, or related area.

· Regulatory Knowledge of (as applicable):

o Regulatory history, guidelines, policies, standards, practices, requirements and precedents

o Regulatory agency structure, processes and key personnel

o Principles and requirements of applicable product laws

o Submission/registration types and requirements

o GxPs (GCPs, GLPs, GMPs)

o Principles and requirements of promotion, advertising and labeling

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o International treaties and regional, national, local and territorial trade requirements,

agreements and considerations

o Domestic and international regulatory guidelines, policies and regulations

o Ethical guidelines of the regulatory profession, clinical research and regulatory process

o Lead functional groups in the development of relevant data to complete a regulatory

submission

· Communication Skills or Ability to:

o Communicate effectively verbally and in writing

o Communicate with diverse audiences and personnel

o Write and edit technical documents

o Work with cross-functional teams

o Work with people from various disciplines and cultures

o Write and edit technical documents

o Negotiate internally and externally with regulatory agencies

o Plan and conduct meetings

· Cognitive Skills or Ability to:

o Strong attention to detail

o Manage projects

o Create project plans and timelines

o Must be able to juggle multiple and competing priorities

o Think analytically with good problem solving skills

o Organize and track complex information

o Exercises judgment within broadly defined practices and policies in selecting methods,

techniques and evaluation criteria for obtaining results

o Has broad knowledge of various technical alternatives and their potential impact on the

business

o Exercises good and ethical judgment within policy and regulations

o Uses in-depth knowledge of business functions and cross group dependencies/ relationships

o Possesses ability to define regulatory strategy

o Able to follow scientific arguments, identify regulatory scientific data needs and solve

regulatory issues

o Perform risk assessment or analysis

· Medical device experience, particularly with Class III devices (implantables)

· Japanese speaking

Senior Regulatory Affairs Specialist – CA - #2145

Our client is a global, broad-based health care company devoted to the discovery, development,

manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and

diagnostics. They are searching for a Senior Regulatory Affairs Specialist in CA.

Key Duties, Activities and Responsibilities:

Our Regulatory Affairs Professional Development Program (RA PDP) is a mid-career-level, three-year

rotation program designed to offer hands-on experience while promoting personal and professional

growth.

As a member of RA PDP you will:

· Be a regular full-time employee of our company and qualify for the same competitive salary and

benefits as other company employees.

· Rotate through three one-year challenging, demanding and diverse Regulatory Affairs

assignments.

· Develop a well-rounded skill set through assignments in the established learning tracks (see

below) for the program.

· Relocate to various sites to experience assignment diversity and operations.

· Be paired with a mentor to assist in the development of your regulatory affairs career.

· Create a personalized growth plan to serve as a step-by-step guide towards the experiences,

knowledge and resources necessary to achieve your career goals.

· Obtain training customized to support your individual growth and development.

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· Report to a department manager in each assignment who will oversee your day-to-day

responsibilities.

Work Experience, Skills and Education Required:

· Possess a Bachelors or Masters Degree in Life Science (i.e. Biology, Chemistry, Immunology,

Medical Technology, Pharmacy, Pharmacology, Microbiology), Math, Engineering, Medical fields or

other related discipline.

· Two to five (2-5) years work experience in Regulatory Affairs or related field.

· Must be eligible to work in the U.S. on a permanent basis.

· Regulatory Affairs related internship/co-op/work experience.

· Strong academic performance and extra curricular achievement.

· Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation,

initiative, integrity and professional maturity.

· Qualified candidates must be interested in continuing careers in Regulatory Affairs.

· Ideal candidates will have no more than five years of regulatory affairs work experience to

qualify for this progr

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

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

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

See most recent Beyond borders: unlocking value Global biotechnology report 2014

At http://www.ey.com/GL/en/Industries/Life-Sciences/EY-beyond-borders-unlocking-value

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

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

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2/7/2016 31

the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for

individuals as well as companies in researching the industry here locally.

See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/

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

Writing Resumes

UC Davis Internship and Career Center Guide to Resumes (2011)

Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf

_____________________________________________________________

NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech

Resumes 2.0, an Employer Perspective

Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley-

Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA

released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of

iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing

and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its

dominance as the world’s preeminent innovation factory.

Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters

and hiring decision makers as well as practical employment search and resume tips, key messages for job

seekers, employers, economic development leaders, educators, and workforce boards.

A link to the report is http://goo.gl/uXTX7

______________________________________________________________

Susan Caldwell wrote an article regarding writing a resume as well.

“10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell

If you're a medical writer, how can you make sure that you still have work in these

tough economic times? Important for staff and freelancers alike, marketing your name

and abilities can be done in many ways. One way is to develop and maintain a living

resume that speaks to the best you have to offer employers.

As an experienced worker, you likely have a professional reputation. Maybe it's good,

or maybe it's not so good. How can you enhance or improve your resume so that your

best shines through? Here are a few suggestions:

1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes

are often input into databases, the simpler the format, the better. Using a simple format should help avoid

the need to reformat before your resume is uploaded into a database. When you submit your resume to a

recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid

bullets, bolding, italics, indents, and 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.

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2. Job Targeting. Decide what your target job or assignment is, and tailor your

resume to that job. How do you do that? For one thing, you can pepper your resume

with the key concepts, terms, and abbreviations for your target job in your resume; this

will show that you know the language in that field. Examples include the terms ICH

Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target

your resume is to rewrite portions of your resume to match the target job description.

This strategy sounds like a lot of work, but it can pay huge dividends. When you submit

a targeted resume, it's more likely you will be considered a great match for the position.

3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD

submission that you worked on). Make it clear that you got the job done in an effective way, particularly if

it saved time or money. You can do this by positioning these stellar achievements toward the resume's

front, writing more about those accomplishments, and/or including specific comments about them in your

resume. If there's a web site or information on the web that illustrates or supplements information about

your accomplishment, link that information to your resume.

4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several

reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the

job. In addition, employers do check resume facts, and they are likely to identify any lies or

inconsistencies.

5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be

flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you

want to open the door to a job interview, show the reader that you are careful about your writing. As a

medical writer, the writing that appears in your resume will be the first writing sample an employer sees.

Be sure that it will stand up to scrutiny.

6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should

be a living document. Update it every time you have new material to add to it. Again, the resume's

purpose is to get your foot in the door for an interview. If you don't 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

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recent job listed first. The work history section should describe your milestone accomplishments for each

job or contract assignment. As with the academic background section, include the start and stop dates for

the jobs and/or contract work that you've done. The dates will give you added credibility.

10. Publications. If you've authored any publications, put a list of them in your resume with the full

citations in a consistent reference format. For publications with multiple authors, you should include all of

the authors' names in the order that they appeared in the publication. Finally, try to get access to

electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume

to the actual articles. In so doing, your reader can easily find and read examples of your work. You can

also prepare a set of publication samples as a zipped file to provide to prospective employers.

Done well, your resume will open many doors for you, including some you may want to walk through.

There are many resources on the internet that will help you create an excellent resume. Take the time to

use them, too! You'll be glad you did.

About the Author

Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research,

she made a major career course correction and never looked back. She found she could make a career of

doing what she loves--writing--and applied it to her 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 [email protected], 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.

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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”

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• “QMed Daily” (formerly DeviceLink.com)

• “PRWeek Healthcare Newsletter”

[email protected]

PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma

http://realendpoints.com/blog/ on pricing and reimbursement

Luke Timmerman’s blog on Xconomy.

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

Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American

Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your

self for the upturn in the job market.”

The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-

make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993.

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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 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 [email protected].

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.

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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

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Salary Surveys

See most recent life scientist salary survey from The Scientist at

http://www.the-scientist.com/?articles.view/articleNo/38033/title/2013-Life-Sciences-Salary-Survey/

Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies.

The fifteenth survey is available at http://www.contractpharma.com/contents/view_salary-survey/2014-

06-05/2014-fifteenth-annual-salary-and-job-satisfaction-/

The most recent salary survey in medtech is “Medtech Salary Survey 2013: A Sneak Peek” by Jamie

Hartford, posted in Medical Device Business, Nov. 5, 2013. See snapshot at

http://www.mddionline.com/article/medtech-salary-survey-2013-sneak-peek See additional comments in

report dated Nov. 27, 2013.

This year’s annual Medical, Marketing and Media salary survey was released in October 2014. The

article entitled “Career and Salary Survey: In Check,” Oct. 2014 is found at

http://editiondigital.net/publication/frame.php?i=226938&p=&pn=&ver=flex

You can download the Premium Edition in pdf at http://media.mmm-

online.com/documents/93/css_2014_premium_edition_23196.pdf

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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.

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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 [email protected] if they wish to receive these

mailings directly.

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