Thermo Fisher Scientific Technical Writer, R&D in Fremont, California
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.
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 Technical Writer III will support clinical development with primary responsibility for the hands-on management of documentation supporting IVD clinical studies. Work 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 scientific and/or technical documents. Review project documentation, assess necessary resources, and estimate timelines for documentation development and review. Knowledge of US and European medical device documentation regulatory requirements would be an advantage. The candidate should have experience with authoring in an agile development environment.
What will you do?
Coordinate with internal and external experts to draft, organize and maintain Design History File (DHF) documentation for IVD products.
Write, analyze, and edit verification/validation protocols and reports for future medical devices.
Collaborate with cross-functional project team to support successful execution of IVD studies.
Craft 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.
Identify 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?
B.S. in a relevant Scientific field, such as Biochemistry, Molecular Biology, or Cell Biology or related discipline.
2+ years of technical writing experience, preferably in the IVD field and with experience in writing documents for regulatory submissions, such as 510k submissions.
Experience with drafting, reviewing, editing verification/validation protocols and reports.
Knowledge of quality and regulatory compliance for IVD product development, especially design controls, per 21 CRF 820.30.
Experience with DOE/statistics a plus.
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
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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.