Principal Medical Writer

Revolution Medicines; United States; Presencial; USD 201 000 - 251 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Equity awards

Strong benefits

Learning & development opportunities

Resumo da oferta

Revolution Medicines, a late-stage oncology biopharma, seeks an experienced clinical regulatory writer to lead the preparation of submission-ready documents across development phases.

You will draft, assemble, and manage content for protocols, IBs, CSRs, and NDA modules while mentoring junior writers and coordinating with cross-functional teams to meet tight timelines.

Qualificações

• 8–11 years of clinical regulatory writing experience in biopharma.
• Advanced degree in clinical or life sciences, English, journalism, or communications.
• Proficiency with MS Word styles and templates; AMA style familiarity.
• Ability to manage multiple deadlines and collaborate cross-functionally.

Responsabilidades

• Serve as medical writing lead on complex regulatory documents (protocols, IBs, CSRs, briefings).
• Draft and review regulatory documents and manage templates and style guides.
• Coordinate with cross-functional teams and planning meetings.
• Schedule reviews, timelines, and adjudication meetings.
• Mentor junior/contract writers on content and timelines.
• Ensure consistency and accuracy across documents.

Conhecimentos

Clinical regulatory writing

Project management

MS Word styles

AMA style

Cross-functional collaboration

Formação académica

Advanced degree in clinical or life sciences, English, journalism, or communications

Ferramentas

StartingPoint

EndNote

Veeva RIM

Smartsheet

Descrição da oferta de emprego

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. 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

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 to the Executive Director, Medical Writing.

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, 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.

Required Skills, Experience and Education

• 8-11 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 Skills

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

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 our CCPA Notice and Privacy Policy. For additional information, please contact [e-mail].

Base Pay Salary Range

$201,000 — $251,000 USD