Details:

Ihre Aufgaben:

• oversee and coordinate the preparation of documentation for regulatory submissions (e.g., investigator brochures, protocols, and clinical study reports) in collaboration with other team members or CROs
• write strategic submission documents (e.g., IMPDs, briefing documents, clinical summaries).
• with the aim to ensure the quality of documents

Ihr Profil:

• Master or Ph.D. in the scientific area (Oncology)
• Experience in Medical Writing in the area of Oncology (min. 2-3 years)
• Experience with regulatory submissions
• Experience with CROs
• Experience with clinical and non-clinical studies
• Experience with local/regional studies, manuscripts, promotion writing, clinical assumptions