Principal Medical Writer
Revolution Medicines
Revolution Medicines seeks a Principal Medical Writer with 8-11 years of clinical regulatory writing experience to lead preparation of submission-ready documents for oncology drug development programs. This individual contributor role includes team leadership responsibilities and requires expertise in clinical regulatory submissions.
Responsibilities
- Lead medical writing on complex clinical regulatory documents including protocols, IBs, CSRs, and NDA modules
- Serve as primary medical writing contact for one or more clinical development programs
- Develop and maintain document templates, processes, and medical writer onboarding materials
- Schedule document reviews, manage adjudication meetings, and mentor junior and contract writers
- Identify scheduling and resource conflicts across projects and recommend resolutions
Requirements
- 8-11 years clinical regulatory writing experience in biopharmaceutical companies
- Prior BLA/NDA/MAA medical writing experience
- Advanced degree in clinical/life sciences, English, journalism, or communications
- Proficiency in Microsoft Word including styles and templates
- Familiarity with AMA style guidelines
- Ability to manage competing deadlines and foster cross-functional collaboration
Vacancy posted 7 days ago
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