Director of Scientific and Medical Writing | Biologe (m/w/d)
BioNTech SE
Job Summary
This senior leadership role, based in Mainz or London, requires a Director of Scientific/Medical Writing to oversee and execute the timely generation of high-quality scientific and regulatory documents for novel therapeutic agents, spanning discovery through post-marketing approval. The Director acts as a departmental subject matter expert, handling complex writing tasks independently, including those requiring extensive adaptation or new definition of standard procedures. Key responsibilities include hands-on writing, editing, and formatting a wide range of documents, coordinating preparation and approval processes, and managing outsourced writing services. Furthermore, the role involves significant line management duties, such as recruiting, supervising, mentoring, and developing a cohesive, flexible, and innovative team, setting performance goals, and managing the budget. The successful candidate must leverage extensive regulatory experience to define company strategies and ensure compliance with international pharmaceutical requirements and good writing practices.
Required Skills
Education
Not specified
Experience
- Extensive prior experience interacting with regulatory authorities
- Professional experience in leading the implementation of role-relevant tools, guidelines, and SOPs
- Professional experience in identifying and implementing process optimizations
- Professional experience in line management, including recruitment, supervision, mentoring, and development of reports
Languages
Additional
- The role is full-time and requires the ability to perform complex medical writing tasks independently, often requiring adaptation of standard procedures. Work location is either Mainz, Germany, or London, United Kingdom.
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