Principal Medical Writer

8-11 years of clinical regulatory writing experience within one or more biopharmaceutical companies, including prior experience working as a medical writer for a BLA/NDA/MAA.

Familiarity with AMA style.

Experience with oncology therapeutics.

Familiarity with StartingPoint, EndNote, Veeva RIM, and Smartsheet.

Experience performing QC reviews of clinical regulatory documents.

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$201,000

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$251,000 USD

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Revolution Medicines is seeking a motivated individual with a clinical regulatory writing background to play a critical role in the successful preparation of high-quality, submission-ready clinical research documents.

This role is an individual contributor with team leadership responsibilities, reporting to the Executive Director, Medical Writing.

This position is responsible for drafting and managing the content and reviews of clinical regulatory documents for Revolution Medicines products in various drug development phases.

Serves as medical writing lead on complex clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, periodic safety reports, risk management documents, and IND and NDA modules.

Assists in developing and maintaining document templates, department standard processes and work instructions, medical writer onboarding materials, and style guide.

Serves as primary medical writing contact for one or more clinical development programs.