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Nonclinical Medical Writer (M/W/D)
Tasks:
Write and quality-control nonclinical sections for regulatory submissions (IBs, INDs, NDAs).
Format documents according to regulatory guidelines and ensure submission-readiness.
Coordinate review meetings, consolidate reviewer comments, and manage version control.
Maintain submission trackers and content plans; obtain published articles and copyrights.
Represent nonclinical medical writing in submission team meetings and discussions.
Qualifications:
Advanced degree in life sciences, pharmacology, toxicology, or related field.
Proven experience in nonclinical medical writing for regulatory submissions.
Strong knowledge of regulatory guidelines and submission requirements.
Excellent writing, editing, and organizational skills; ability to manage multiple tasks.
- Collaborative team player with effective communication skills.
Requirements:
Start: latest 01.10.2025
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