Principal Medical Writer
The Opportunity: 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+ 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.
#LI-Hybrid #LI-JC1 The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Base Pay Salary Range $201,000-$251,000 USD We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address. If you believe you've been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness. Apply tot his job Apply To this Job