Senior Medical Writer, Medical Writing
Third Rock Ventures - Redwood City, CA
posted 4 days ago
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 scientists 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 Senior Director, Medical Writing.
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, IBs, and CSRs, briefing documents, and IND and NDA modules.
- Manage multiple and overlapping document timelines in a dynamic environment.
- Effectively communicate deliverables needed, the writing process, and timelines to team members.
- Schedule document reviews in PleaseReview 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.
- Support the Senior Director, Medical Writing, and mentor junior and contract medical writers, as needed.
Requirements
- 10+ years of medical writing experience within the pharmaceutical industry, including experience with oncology therapeutics.
- Advanced degree in the life sciences.
- Proficient in Microsoft Word.
- Familiar with AMA style, PleaseReview, StartingPoint, EndNote, and Smartsheet.
- Detail-oriented, compelled to check for errors in spelling, punctuation, grammar, and formatting.
- Able to successfully manage and prioritize writing projects with competing deadlines.
- Able to foster strong collaborative relationships with clinical development team members to ensure timely completion of high quality submissions and compliance with regulatory processes and standards.
- Outstanding interpersonal and communication skills: able to work with multiple groups of people at one time, remaining calm, professional, diplomatic, and positive.
Nice-to-haves
- A second degree in English, journalism, or communications.
- Experience performing QC reviews of clinical regulatory documents.
Benefits
- Competitive cash compensation
- Robust equity awards
- Strong benefits
- Significant learning and development opportunities
