Principal Medical Writer

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins, including daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, currently in clinical development.

About the role

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. You will join a team of outstanding professionals committed to patients with cancers harboring mutations in the RAS signaling pathway.

Responsibilities

• Draft and manage the content and reviews of clinical regulatory documents for Revolution Medicines products in various drug development phases.
• Serve as medical writing lead on complex clinical regulatory documents, including protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), briefing documents, periodic safety reports, risk management documents, and IND and NDA modules.
• Assist in developing and maintaining document templates, department standard processes and work instructions, medical writer onboarding materials, and style guide.
• Serve as primary medical writing contact for one or more clinical development programs.
• Represent medical writing at cross-functional planning meetings.
• Communicate deliverables, the writing process, and timelines to team members.
• Schedule document reviews and manage adjudication meetings.
• Hold team members accountable to agreed-upon project dates.
• Independently resolve document content issues and questions.
• Ensure consistency, clarity, and accuracy both within and across documents.
• Recognize potential scheduling and resource conflicts across projects and provide recommendations to resolve.
• Mentor junior and contract medical writers on both document and timeline management.

Requirements

• 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.
• Ability to foster collaborative cross-functional relationships.
• Ability 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.

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $201,000 - $251,000 USD. The range displayed is intended for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Base pay salary is determined by role, level, location, job-related skills, experience, market dynamics, and relevant education or training.

Benefits

Revolution Medicines offers competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities as part of the overall total rewards program.