Revolution Medicines
Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
ab CHF 204.000 - 255.000 / Jahr
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RERevolution Medicines
Director, Principal Medical Writer, Europe(m/w/x)
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Authoring, editing, and coordinating clinical regulatory documents for novel targeted therapies in oncology. Advanced degree in life sciences or related scientific discipline required. Late-stage clinical development, European regulations and guidelines understanding.
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Anforderungen
- Thorough understanding of oncology drug development
- Thorough understanding of applicable European regulations
- Thorough understanding of applicable European guidelines
- Advanced degree in life sciences
- Advanced degree in a related scientific discipline
- Minimum 10+ years regulatory medical writing experience
- Experience within biotechnology industry
- Experience within pharmaceutical industry
- Demonstrated experience authoring documents for European regulatory submissions
- Experience preparing responses to Health Authority questions
- Thorough understanding of ICH guidelines
- Thorough understanding of EU Clinical Trial Regulation
- Thorough understanding of EMA regulatory procedures
- Thorough understanding of GCP principles
- Strong scientific writing skills
- Strong editing skills
- Exceptional attention to detail
- Excellent project management skills
- Excellent organizational skills
- Ability to manage multiple simultaneous projects
- Ability to work in a fast-paced environment
- Strong interpersonal skills
- Strong communication skills
- Demonstrated ability to work across multidisciplinary global teams
- Excellent written English
- Excellent verbal English
- Oncology regulatory writing experience
- Experience supporting EMA Scientific Advice
- Experience supporting Marketing Authorisation Applications
- Experience with centralized European regulatory procedures
- Experience with decentralized European regulatory procedures
- Experience with national European regulatory procedures
- Experience with eCTD submissions
- Familiarity with Veeva Vault RIM
- Familiarity with StartingPoint
- Familiarity with EndNote
- Familiarity with SmartSheet
- Familiarity with document management systems
- Experience performing quality control reviews of regulatory documents
- Experience working within small biotechnology companies
- Experience working within mid-sized biotechnology companies
Aufgaben
- Author, edit, and coordinate high-quality clinical regulatory documents
- Prepare responses to Health Authority questions
- Prepare Scientific Advice briefing books and meeting packages
- Prepare Risk Management Plans
- Prepare periodic safety documents
- Serve as a medical writing lead for complex clinical regulatory documents
- Support clinical development including protocols, IBs, CSRs, and CTA modules
- Prepare other regulatory documents supporting lifecycle management, variations, and renewals
- Coordinate preparation of responses to regulatory agency requests for information
- Ensure consistency across multidisciplinary functional contributions
- Lead document planning, review cycles, comment resolution, and finalization
- Ensure adherence to project timelines
- Collaborate with Global and European Regulatory Affairs
- Ensure documents support the overall regulatory strategy
- Ensure compliance with ICH guidelines, EMA guidance, GCP, company standards, and document templates
- Facilitate document review meetings
- Manage cross-functional comment adjudication
- Identify potential scientific or regulatory inconsistencies
- Work with subject matter experts to resolve issues
- Maintain consistency across related submission documents and development programs
- Support development and continuous improvement of medical writing processes, templates, style guides, and SOPs
- Mentor junior writers
- Contribute to departmental best practices
Berufserfahrung
10 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
Veeva Vault RIMStartingPointEndNoteSmartSheeteCTD submissions
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Revolution MedicinesÜber das Unternehmen
RE
PharmaceuticalsBasel
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
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