Senior Medical Expert (m/w/d) in Hamburg

• Assess and manage requests within Managed Access Programs and Named Patient Use frameworks, incorporating clinical and ethical perspectives
• Develop comprehensive benefit-risk arguments while ensuring compliance with regulatory requirements
• Collaborate closely with cross-functional teams including Regulatory Affairs, Legal, Pharmacovigilance, and Commercial to shape access strategies
• Prepare, review, and take ownership of clinical and regulatory documentation, including CTD Modules (Clinical Overview, Clinical Summary), expert statements, risk management documentation (RMPs), safety reports (PSURs / DSURs), and labeling texts (SmPC, CCDS, PIL)
• Maintain a high standard of scientific quality and consistency across all regulatory deliverables, including those related to complex products such as ATMPs
• Support the development of regulatory strategies, briefing documents, and interactions with global health authorities, including scientific advice procedures

Your Profile

• Medical degree (MD) is required
• Solid expertise in global drug development processes and regulatory requirements
• Proven experience across clinical trial phases (I-III), including medical monitoring and clinical practice
• Background in advanced therapies (e.g., ATMPs or cell therapies) is highly desirable, along with experience in early access programs and CTD authoring (especially Module 2)
• Therapeutic knowledge in areas such as oncology, hematology, immunology, or rheumatology
• Strong capability in scientific writing combined with the ability to convey complex information effectively
• Analytical mindset with a structured approach to benefit-risk evaluation
• Skilled in transforming scientific insights into strategic recommendations
• Fluent in English; additional German language skills are advantageous