Director of Scientific and Medical Writing | Pharmacist (m/w/d)
Unknown Employer
Job Summary
This Director role focuses on leading and executing the timely generation of high-quality scientific and regulatory documents for novel therapeutic agents, spanning from discovery through post-marketing approval. Key responsibilities include hands-on writing, editing, and formatting of complex documents, coordinating preparation and approval processes, and ensuring compliance with international pharmaceutical regulations and good writing practices. The Director also acts as a line manager, responsible for recruiting, supervising, mentoring, and developing a cohesive and innovative team. Furthermore, the role involves acting as a departmental subject matter expert, driving process optimization, and defining company strategies and standards for regulatory medical writing activities. This position requires extensive prior experience interacting with regulatory authorities and the ability to independently manage and lead complex writing tasks with no supervision.
Required Skills
Education
Not specified
Experience
- Extensive prior experience interacting with regulatory authorities
- Professional experience in scientific/medical writing for therapeutic agents (discovery through post-approval)
- Experience in managing outsourced tasks and external writers
- Leadership experience in line managing and developing a team
Languages
Additional
- Located in Mainz, Germany or London, United Kingdom