Medical Writing Manager
A large pharmaceutical organisation is looking for an experience Medical Writer to manage a team in Maidenhead.
The Medical Writing Manager will collaborate with project teams on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs) and oversees the work of contract writers on the clinical program.
- Produce high quality and on-time writing deliverables.
- Plan, write, edit, and format key documents, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications.
- Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors.
- Represent Medical Writing on multiple early phase project teams or on specific late phase project teams and collaborate with the Director of Medical Writing to ensure proper planning for upcoming project writing deliverables.
- Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders.
- Serve as subject matter expert for clinical documents and their production.
- Contribute to SOP and template development and maintenance
Skills and Requirements
- Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred.
- Demonstrated experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus.
- In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
- Impeccable attention to detail and ability to complete writing assignments in a timely manner with little to no oversight.
- Experience overseeing the work of contract writers is a plus.
- Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.