Located in Paris, France (Fully Remote!)
Scope
- Writing complex scientific, clinical and regulatory documents (e.g. protocols, clinical study reports, briefing documents, CTD modules) over a range of therapeutic areas according appropriate standards and requirements (e.g. ICH).
- Interacting with clients, especially with the clinical teams. Collaborating to produce high-quality documents.
- Mentoring junior scientific writers.
Key Responsibilities
- Writing investigational medicinal product dossiers, investigator brochures, clinical study concept protocols, protocols and protocol amendments, informed consent forms, assent forms, clinical study reports, and summary (Module 2) documents for licensing applications.
- Compiling and publishing complex documents (e.g., clinical study reports)
- Writing patient narratives and other pharmacovigilance documents (e.g., DSURs, PBRERs, RMPs)
- Translating scientific articles, clinical documents and media materials
- Performing literature reviews
- Participating in the review of statistical analysis plans and providing input on the layout of Tables, Figures and Listings
- Performing Quality Control and/or peer-reviews of documents
- Ensuring that document and standards timelines are met
- Participating in the creation, usage and maintenance of document templates and SOPs
Qualifications
- Graduate / Post-graduate degree in Medicine, Pharmacy or a Scientific Field
- At least 10 years of experience writing protocols, study reports, briefing documents and/or clinical CTD modules are a must
- Fluent in English with excellent written proficiency in the language
- Computer literacy (Word, PowerPoint, Excel)
Apply below or get in touch if you are interested!
+44 (0) 203375 8278
