Director, Principal Medical Writer, Europe

Das ist der Job

The company’s RD pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins.

Darum lohnt es sich

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. /ph3The Opportunity: /h3pAs 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. /ppThe 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. /ppThe 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. /ppThe role will report to the VP, Regulatory Affairs, Europe. /ph3Primary Responsibilities: /h3ulliAuthor, edit and coordinate high-quality clinical regulatory documents, including: /liliResponses to Health Authority questions (EMA, MHRA, Swissmedic, etc). /liliScientific Advice briefing books and meeting packages. /liliRisk Management Plan (RMP). /liliPeriodic safety documents (as applicable). /liliAs needed, serve as a medical writing lead for complex clinical regulatory documents, supporting clinical development including protocols, IBs, CSRs, and CTA modules. /liliOther regulatory documents supporting lifecycle management, variations and renewals. /liliCoordinate preparation of responses to regulatory agency requests for information, ensuring consistency across multidisciplinary functional contributions. /liliLead document planning, review cycles, comment resolution and finalization while ensuring adherence to project timelines. /liliCollaborate closely with Global and European Regulatory Affairs to ensure documents support the overall regulatory strategy. /liliEnsure all documents comply with applicable ICH guidelines, EMA guidance, GCP, company standards and document templates. /liliFacilitate document review meetings and manage cross-functional comment adjudication. /liliIdentify potential scientific or regulatory inconsistencies and work with subject matter experts to resolve issues. /liliMaintain consistency across related submission documents and across development programs. /liliSupport development and continuous improvement of medical writing processes, templates, style guides and standard operating procedures. /liliMentor junior writers when appropriate and contribute to departmental best practices. /li /ulpThe candidate must have a thorough understanding of oncology drug development, applicableEuropean regulations and guidelines. /ph3Required Skills, Experience and Education: /h3ulliAdvanced degree (PhD, PharmD, MD, MSc or equivalent) in life sciences or a related scientific discipline. /liliMinimum 10+ years of regulatory medical writing experience within the biotechnology or pharmaceutical industry. /liliDemonstrated experience authoring documents supporting European regulatory submissions. /liliExperience preparing responses to Health Authority questions during CTA, MAA or post-approval procedures. /liliThorough understanding of: /liliStrong scientific writing and editing skills with exceptional attention to detail. /liliExcellent project management and organizational skills. /liliAbility to manage multiple simultaneous projects in a fast-paced environment. /liliStrong interpersonal and communication skills with demonstrated ability to work across multidisciplinary global teams. /liliExcellent written and verbal English. /li /ulh3Preferred Skills: /h3ulliOncology regulatory writing experience. /liliExperience supporting EMA Scientific Advice and/or Marketing Authorisation Applications. /liliExperience with centralized, decentralized or national European regulatory procedures. /liliExperience with eCTD submissions. /liliFamiliarity with Veeva Vault RIM, StartingPoint, EndNote, SmartSheet and document management systems. /liliExperience performing quality control reviews of regulatory documents. /liliExperience working within small or mid-sized biotechnology companies. /liliExperience supporting European regulatory submissions. /li /ulpRevolution 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. ppRevolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.

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.

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 /pp#LI-LO1 #LI-Hybrid /p /p