What are the responsibilities and job description for the Principal Medical Writer, Development position at Revolution Medicines?
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value 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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Our Medica Writing team 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.
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
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
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 on 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 PleaseReview, StartingPoint, EndNote, and Smartsheet
Experience performing QC reviews of clinical regulatory documents
The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary 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.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes the protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process, and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
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Salary : $204,000 - $255,000
