The focus on NONCLINICAL writing is essential!
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: 01.10.2025
Duration: 12 months
Capacity: 30 hours/week
Location: Full Remote
Language: English, (French: nice to have)