Basel, Basel-City, Switzerland · Hybrid
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 dive…
Skills: Regulatory medical writing, Oncology drug development, Clinical regulatory documentation, EMA regulatory procedures, ICH guidelines
Vienna, Austria · Hybrid
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 dive…
Skills: Oncology, Commercial Strategy, Product Launch, Market Access, Medical Affairs
Basel, Basel-City, Switzerland · Remote OK
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 dive…
Skills: Oncology, Commercial Strategy, Product Launch, Market Access, Medical Affairs
Redwood City, California, United States · Hybrid
$186k–$233k/yr
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 dive…
Skills: Product Management, Commercial Data Products, Commercial Technology, CRM, Omnichannel
Redwood City, California, United States · Hybrid
$99k–$124k/yr
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 dive…
Skills: Application administration, SaaS management, Identity and access management, Active Directory, Microsoft Entra ID
Redwood City, California, United States · On-site
$265k–$331k/yr
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 dive…
Skills: Commercial drug product manufacturing, Primary packaging, CMO management, Technology transfer, Process validation
Redwood City, California, United States · On-site
$119k–$149k/yr
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 dive…
Skills: Drug product development, Formulation development, Process development, Solid oral dosage forms, Process scale-up
Basel, Basel-City, Switzerland · Hybrid
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 dive…
Skills: HR Operations, Payroll Management, Benefits Administration, Project Management, Stakeholder Management
Basel, Basel-City, Switzerland · Hybrid
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 dive…
Skills: Project Management, Business Analysis, Technical Project Management, Stakeholder Management, Requirements Gathering
United States · Remote OK
$177k–$221k/yr
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 dive…
Skills: Oncology marketing, HCP marketing, Launch strategy, Strategic planning, Cross-functional leadership
United States · Remote OK
$201k–$251k/yr
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 dive…
Skills: Strategic marketing, Omnichannel marketing, Oncology, Launch strategy, Cross-functional leadership
Amsterdam, North Holland, Netherlands · Hybrid
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 dive…
Skills: Pharmacovigilance, EU PV legislation, GVP, Signal management, Risk management
Redwood City, California, United States · Hybrid
$91k–$110k/yr
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 dive…
Skills: Cancer biology, Molecular biology, Cell biology, Quality control, Data analysis
Basel, Basel-City, Switzerland · Hybrid
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 dive…
Skills: Commercial Law, Distribution Agreements, Contract Negotiation, Life Sciences, Oncology
Redwood City, California, United States · Hybrid
$164k–$205k/yr
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 dive…
Skills: Quality Control, Analytical Development, cGMP, Regulatory Compliance, Method Validation
Poland · Hybrid
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 dive…
Skills: Oncology, Clinical research, Drug development, Scientific communication, Relationship management
Poland · Remote OK
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 dive…
Skills: Medical Affairs, Oncology, Strategic Planning, Stakeholder Management, Key Opinion Leader Engagement
Poland · Remote OK
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 dive…
Skills: Market Access, Pricing, Reimbursement, Health Economics, HTA
Poland · Hybrid
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 dive…
Skills: Oncology, Commercial Strategy, Launch Planning, Market Access, Medical Affairs
Redwood City, California, United States · On-site
$150k–$189k/yr
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 dive…
Skills: Compliance monitoring, Data analytics, Risk management, Internal audit, Healthcare compliance
Basel, Basel-City, Switzerland • Hybrid
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The Principal Medical Writer will author, coordinate, and finalize complex clinical regulatory documents to support European and international health authority interactions. They will collaborate with cross-functional teams to ensure scientific accuracy, strategic alignment, and compliance with regional regulatory requirements.
Candidates must hold an advanced degree in life sciences and possess at least 10 years of regulatory medical writing experience within the pharmaceutical or biotechnology industry. A thorough understanding of oncology drug development, ICH guidelines, and European regulatory procedures is required.
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.
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, applicable European regulations and guidelines.
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:
ICH guidelines (including E3, M4, E6)
EU Clinical Trial Regulation (EU CTR 536/2014)
EMA regulatory procedures
GCP principles
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.
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.
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 [email protected].
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Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.
Revolution Medicine enables physicians to integrate personalized medicine into their practices in order to more effectively treat patients. Our genes play an important role in determining how we respond to about 75% of prescription drugs. Scientific research has demonstrated which genes predict these responses. According to the American Medical Association (AMA), 98% of physicians agree that knowing a patient’s genetic profile would help in prescribing medications. Yet, 90% of physicians do not feel they are adequately informed about how to apply genetic testing to treatment decisions. Our mission is to improve the quality of patient care by helping doctors determine optimal treatment strategies and more accurately predict treatment responses. Revolution Medicine has developed ScriptMatch, an analytical process that enables physicians to easily incorporate genetic testing into their practices. Our company solves a major issue in the clinical market and addresses an emerging trend in patient-driven healthcare: having clinical results that become part of the medical record and applicable to future treatments.
View all jobs at Revolution MedicineRevolution Medicine enables physicians to integrate personalized medicine into their practices in order to more effectively treat patients. Our genes play an important role in determining how we respond to about 75% of prescription drugs. Scientific research has demonstrated which genes predict these responses. According to the American Medical Association (AMA), 98% of physicians agree that knowing a patient’s genetic profile would help in prescribing medications. Yet, 90% of physicians do not feel they are adequately informed about how to apply genetic testing to treatment decisions. Our mission is to improve the quality of patient care by helping doctors determine optimal treatment strategies and more accurately predict treatment responses. Revolution Medicine has developed ScriptMatch, an analytical process that enables physicians to easily incorporate genetic testing into their practices. Our company solves a major issue in the clinical market and addresses an emerging trend in patient-driven healthcare: having clinical results that become part of the medical record and applicable to future treatments.
View all jobs at Revolution Medicine