Principal Medical Writer

Revolution Medicines

86d • $204,000 - $255,000

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. 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 into the Executive Director, Medical Writing.

Requirements

• 8+ years of clinical regulatory writing experience within one or more biopharmaceutical companies, including prior experience working as a medical writing 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.

Nice To Haves

• Experience with oncology therapeutics.
• Familiarity with PleaseReview, StartingPoint, EndNote, and Smartsheet.
• Experience performing QC reviews of clinical regulatory documents.

Responsibilities

• 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 manages adjudication meetings.
• Holds team members accountable to agreed-upon project dates.
• Independently resolves document content issues and questions.
• Ensures 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.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree