Director of Scientific and Medical Writing | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This Director role focuses on leading the timely production of high-quality scientific and regulatory documentation essential for developing novel therapeutic agents, from early discovery through post-marketing approval. The position requires extensive hands-on experience in complex scientific/medical writing, often necessitating the adaptation or definition of new procedures without supervision. Key responsibilities include writing, editing, and formatting a wide range of research, non-clinical, and clinical documents, managing document preparation and approval processes, and overseeing outsourced writing tasks. Furthermore, the Director acts as a line manager, responsible for recruiting, supervising, mentoring, and developing a cohesive, innovative team, setting performance goals, and managing the budget. The successful candidate must also serve as a departmental subject matter expert, driving process optimization and ensuring compliance with international pharmaceutical regulations and good writing practices.
Required Skills
Education
Not specified
Experience
- Extensive prior experience interacting with regulatory authorities
- Professional experience in scientific/regulatory document generation
- Experience in leading the implementation of role-relevant tools and guidelines
- Professional experience in line management and team development
Languages
Additional
- Not specified
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