The Opportunity:

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.

• Represents medical writing at cross-functional planning meetings.

• Effectively communicates deliverables needed, the writing process, and timelines to team members.

• Schedules document reviews and manage adjudication meetings.

• Holds team members accountable to agreed-upon project dates.

• Independently resolves document content issues and questions.

• Ensure consistency, clarity, and accuracy both within and across documents.

• Recognizes potential scheduling and resource conflicts across projects and provides recommendations to resolve.

• Mentors junior and contract medical writers on both document and timeline management.

Required Skills, Experience and Education:

• 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.

• Advanced degree in clinical or life sciences, English, journalism, and/or communications.

• Proficiency in Microsoft Word, including the use of MS Word styles and templates.

• Familiarity with AMA style.

• Ability to successfully manage and prioritize writing projects with competing deadlines, to foster collaborative cross-functional relationships, and to drive high-quality regulatory writing projects to successful submission.

• Ability to work in a high-pressure environment with short deadlines while remaining calm, focused, professional, diplomatic, and positive.

Preferred Skills:

• Experience with oncology therapeutics.

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

• Experience performing QC reviews of clinical regulatory documents. 

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