Ihre Aufgaben:
* Drafting and revising regulatory documents in accordance with EU requirements (e.g., CTD Modules 2.5 and 2.7)
* Ensuring compliance with regulatory standards and guidelines (e.g., EMA, ICH)
* Collaborating with internal teams to align on content and timelines
* Supporting strategic planning and execution of the dossier update
Ihre Qualifikationen:
* Proven experience as a Medical Writer in a regulatory setting, preferably with a focus on migraine therapeutics
* Familiarity with European regulatory documentation requirements
* Knowledge of triptans or other migraine-related active substances
* Excellent written and spoken English skills
* Independent, structured, and reliable working style
Ihre Vorteile:
* Remote work possible