Director, Principal Medical Writer, Europe

Revolution Medicines; Basel; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

Revolution Medicines is seeking an experienced Principal Regulatory Medical Writer to lead the preparation of regulatory documentation for clinical development and marketing authorization across Europe. You will collaborate with Regulatory Affairs, Clinical Development, and cross-functional teams to author, coordinate and finalize submissions.

The role reports to the VP, Regulatory Affairs, Europe. You will serve as lead author for complex regulatory documents, ensuring scientific accuracy,

Qualifikationen

• Advanced degree in life sciences or related field.
• Minimum 10+ years of regulatory medical writing experience.
• Experience supporting European regulatory submissions (CTA/MAA).
• Strong command of English, excellent writing/editing skills.

Aufgaben

• Author, edit and coordinate regulatory documents for European approvals.
• Respond to Health Authority questions (EMA/MHRA/Swissmedic).
• Lead complex regulatory documents (protocols, IBs, CSRs, CTAs).
• Coordinate responses for information requests; ensure consistency across teams.
• Mentor junior writers and improve medical writing processes.
• Ensure ICH/EMA/GCP compliance and document templates are followed.

Kenntnisse

Regulatory writing

European submissions

ICH guidelines

Project management

Cross-functional collaboration

English proficiency

Ausbildung

PhD/PharmD/MD/MSc or equivalent

Tools

Veeva Vault RIM

StartingPoint

EndNote

SmartSheet

Jobbeschreibung

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:

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.
• Coordinate preparation of responses to regulatory agency requests for information, ensuring consistency across multidisciplinary functional contributions.
• Lead document planning, review cycles, comment resolution and finalization while ensuring adherence to project timelines.
• Collaborate closely with Global and European Regulatory Affairs to ensure documents support the overall regulatory strategy.
• Ensure all documents comply with applicable ICH guidelines, EMA guidance, GCP, company standards and document templates.
• Facilitate document review meetings and manage cross-functional comment adjudication.
• Identify potential scientific or regulatory inconsistencies and work with subject matter experts to resolve issues.
• Maintain consistency across related submission documents and across development programs.
• Support development and continuous improvement of medical writing processes, templates, style guides and standard operating procedures.
• Mentor junior writers when appropriate and contribute to departmental best practices.

The candidate must have a thorough understanding of oncology drug development, applicableEuropean regulations and guidelines.

Required Skills, Experience and Education:

• Advanced degree (PhD, PharmD, MD, MSc or equivalent) in life sciences or a related scientific discipline.
• Minimum 10+ years of regulatory medical writing experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience authoring documents supporting European regulatory submissions.
• Experience preparing responses to Health Authority questions during CTA, MAA or post-approval procedures.
• Thorough understanding of:
• Strong scientific writing and editing skills with exceptional attention to detail.
• Excellent project management and organizational skills.
• Ability to manage multiple simultaneous projects in a fast-paced environment.
• Strong interpersonal and communication skills with demonstrated ability to work across multidisciplinary global teams.
• Excellent written and verbal English.

Preferred Skills:

• Oncology regulatory writing experience.
• Experience supporting EMA Scientific Advice and/or Marketing Authorisation Applications.
• Experience with centralized, decentralized or national European regulatory procedures.
• Experience with eCTD submissions.
• Familiarity with Veeva Vault RIM, StartingPoint, EndNote, SmartSheet and document management systems.
• Experience performing quality control reviews of regulatory documents.
• Experience working within small or mid-sized biotechnology companies.
• Experience supporting European regulatory submissions.

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