Associate Director Scientific/Medical Writing
On-site · Mainz, Rheinland-Pfalz, Germany
Job Summary
Associate Director role focused on creating, editing, and formatting a wide range of scientific and regulatory documents for research, non-clinical, clinical development, and post-approval life cycle, with coordination of document preparation and external writers. Ensure content quality and regulatory compliance, implement templates and SOPs, support tools and training, and contribute to high-impact medicinal writing across immunology/oncology programs. Requires advanced science degree, 5+ years in pharma/biotech writing, experience with CTD modules and regulatory documents, and strong English skills (German advantageous).
Required Qualifications
- A relevant science/medical university degree (MD, PharmD, PhD preferred)
- 5+ years hands-on experience in drug development or medical writing in pharmaceutical/biotech
- experience drafting documents for multiple indications and CTD modules/CSRs for Phase I-III
- drafting IBs, clinical CTD modules, DSURs/Annual Reports, RMPs, PIPs/PSPs, and other CTD Module 1 documents
- editing/reviewing R&D reports; extracting and summarizing scientific results
- native-level written and spoken English; German skills advantageous
- ability to interpret scientific results clearly and concisely; attention to detail
- MS Word/MS 365, Adobe Acrobat Pro, SharePoint; DMS authoring tools
- knowledge of ICH guidelines and regulatory requirements (ICH E3, E6, E9; FDA guidance; EU CTR; GDPR)
- experience with drug development processes and stakeholder needs
- statistics, trial design, data reporting in immunotherapeutic contexts
- ability to work under tight timelines and prioritize work
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