Principal Medical Writer

Role: Senior medical writer specializing in clinical regulatory documentation for biopharma oncology products, reporting to the Executive Director, Medical Writing. Responsibilities: lead the drafting and review of complex regulatory documents such as protocols, IBs, CSRs, safety reports, and regulatory modules for RAS-targeted therapies in various development phases; develop templates and standards; serve as primary contact for programs; facilitate reviews and cross-functional communication; mentor junior writers. Requirements: 8-11 years of clinical regulatory writing experience, including BLA/NDA/MAA submissions; advanced degree in life sciences, English, journalism, or communications; proficiency in MS Word, familiarity with AMA style; strong project management and cross-team collaboration skills; ability to work under tight deadlines. Preferred: oncology therapeutic experience, familiarity with regulatory tools like Veeva RIM and EndNote, experience with QC reviews. High-Value: focus on oncology, biologics or small molecules, clinical phase development, regulatory submission expertise, cross-functional stakeholder engagement. Work Setup: onsite in Redwood City, CA, with a salary range of $201,000–$251,000, plus benefits and equity.