Principal Medical Writer
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Job Location:
Redwood City, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
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.
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.
Required Experience Skills and Education:
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.
Preferred Skills:
Experience with oncology therapeutics.
Familiarity with PleaseReview StartingPoint EndNote and Smartsheet.
Experience performing QC reviews of clinical regulatory documents. #LI-Hybrid #LI-YG1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base pay salary range 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 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 ourCCPA additional information please contact.
Required Experience:
Staff IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
