Senior Medical Writer, Medical Writing
Redwood City, United States
Job Description
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.
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, and CSRs, briefing documents, and IND and NDA modules.
- Manages multiple and overlapping document timelines in a dynamic environment.
- Effectively communicates deliverables needed, the writing process, and timelines to team members.
- Schedules document reviews in PleaseReview 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.
- Supports the Senior Director, Medical Writing, and mentors junior and contract medical writers, as needed.
Required Experience, Skills, and Education:
- 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.
Preferred Skills, Experience and Education:
- A second degree in English, journalism, or communications.
- Experience performing QC reviews of clinical regulatory documents.
Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.
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Career Focus: Analyst, Medical Affairs, Medical Writing
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