Medical Writer

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

As part of our expanding European organization, we are seeking an experienced Principal Regulatory Medical Writer to support the preparation of high-quality regulatory documentation for clinical development and marketing authorization activities across Europe. Working closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biometrics, Pharmacovigilance, CMC, and other cross-functional teams, the successful candidate will author, coordinate and finalize regulatory documents supporting interactions with European and international Health Authorities.

The candidate will serve as the lead author for complex regulatory documents and will ensure documents are scientifically accurate, strategically aligned, compliant with ICH, EU and applicable regional requirements, and submission-ready.

The successful candidate will play a key role in supporting regulatory interactions with European Health Authorities by developing clear, scientifically robust, and strategically aligned regulatory documentation throughout the product lifecycle.

The role will report to the VP, Regulatory Affairs, Europe.

Primary Responsibilities:

• Author, edit and coordinate high-quality clinical regulatory documents, including:

• Responses to Health Authority questions (EMA, MHRA, Swissmedic, etc).

• Scientific Advice briefing books and meeting packages.

• Risk Management Plan (RMP).

• Periodic safety documents (as applicable).

• As needed, serve as a medical writing lead for complex clinical regulatory documents, supporting clinical development including protocols, IBs, CSRs, and CTA modules.

• Other regulatory documents supporting lifecycle management, variations and renewals.