Principal Medical Writer jobs in United States
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Revolution Medicines · 1 month ago

Principal Medical Writer

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. They are seeking a motivated individual with a clinical regulatory writing background to prepare high-quality, submission-ready clinical research documents and lead medical writing efforts for clinical development programs.

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H1B Sponsor Likelynote

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 manage adjudication meetings
Holds team members accountable to agreed-upon project dates
Independently resolves document content issues and questions
Ensure 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

Qualification

Clinical regulatory writingBLA/NDA/MAA experienceAdvanced degree in life sciencesMicrosoft Word proficiencyOncology therapeutics experienceDocument QC reviewsAMA styleProject management skillsMentoring skillsCommunication skills

Required

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

Experience with oncology therapeutics
Familiarity with StartingPoint, EndNote, Veeva RIM, and Smartsheet
Experience performing QC reviews of clinical regulatory documents

Benefits

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

Company

Revolution Medicines

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Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

H1B Sponsorship

Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.25B
Key Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M

Leadership Team

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Luan Wilfong
Chief Human Resources Officer
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Steve Kelsey
President
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Company data provided by crunchbase