Public summary
Join an established Clinical Research Organization as a Senior Medical Writer to produce and coordinate complex medical writing deliverables such as informed consent forms, clinical study reports, and CTD submissions. The role involves collaboration with various departments to ensure scientific accuracy and regulatory compliance, mentoring junior writers, and liaising with sponsors. This full-time position is open to candidates based in multiple European countries including Germany.
Location and work setup
- Location
- Freiburg (Elbe)
- Remote status
- Hybrid
- German requirement signal
- No German Required Detected
- Detected job language
- English
Responsibilities
Write and edit complex medical writing deliverables including informed consent forms, clinical study reports, clinical evaluation reports, and CTD submissions according to SOPs and regulatory guidelines. Coordinate with cross-functional teams to gather and integrate scientific and clinical content. Ensure accuracy, consistency, and regulatory compliance of documents. Lead and mentor less experienced medical writers. Liaise with sponsors to negotiate changes and align expectations.
Qualifications
Degree in Life Sciences with at least 3 years of medical writing experience, including protocols, CSRs and CTDs. Fluency in English is required. Previous experience in a CRO environment and project management skills are advantageous.