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Job Details

Technical Writer III RampD

Company name
Thermo Fisher Scientific Inc.

Location
Fremont, CA, United States

Employment Type
Full-Time

Industry
It, Writing

Posted on
Jul 12,2019

Valid Through
Oct 25,2019

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Job Description

Job Title:

Technical Writer III, R&D

Requisition ID

: 98865BR

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Fremont, CA | Clinical Diagnostics Division

How will you make an impact?

We are looking for innovative candidates to be a key contributor in supporting the development of cutting edge diagnostic methods that will have a direct impact on patient lives. The candidate will support clinical development with primary responsibility for the hands-on management of documentation supporting In Vitro Diagnostic (IVD) product development. This candidate will work closely with cross functional development teams to write, edit, review and finalize technical documents required for regulatory submissions of IVD products which includes but not limited to documents for pre-submissions, verification and validation protocols and reports. The secondary role for the candidate is to draft, edit, review and finalize technical documents needed to support on-market product improvement projects. The candidate will also review project documentation, assess necessary resources, and estimate timelines for documentation development and review. Knowledge of US and European medical device documentation regulatory requirements (21 CFR 820.30 & ISO 13485) desired.

What will you do?

Coordinating with internal and external experts to draft, organize, maintain and update Design History File (DHF) documentation for IVD products.

Writing, analyzing, and editing verification and validation protocols and reports for medical devices.

Collaborates with cross-functional project team to support successful execution of IVD studies.

Crafting protocols to verify design inputs and validate user needs from cross-functional groups and individuals including, R&D scientists, medical experts, regulatory affairs, quality and marketing.

Identifying opportunities to improve the efficiency and effectiveness of procedures and processes.

Perform other responsibilities to support the needs of the department as assigned.

How will you get here?

Education

B.S. in a relevant scientific field, such as biochemistry, molecular biology, or cell biology.

Experience

At least 4 years of technical writing experience, preferably in the IVD/Medical Device industry.

Experience with drafting, reviewing, editing verification/validation protocols and reports.

Experience in writing documents for regulatory submissions is a plus (e.g. 510k, Design Dossiers, Technical Files, etc.)

Knowledge, Skills, Abilities

Knowledge of quality and regulatory compliance requirements for IVD product development, especially design controls, per 21 CRF 820.30.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process,

click here

for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Company info

Thermo Fisher Scientific Inc.
Website : http://www.thermofisher.com

Company Profile
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

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