Medical Expert (m/w/d)

About the role

We are seeking a Medical Expert to lead clinical and regulatory activities within Managed Access Programs and Named Patient Use frameworks. The role combines scientific assessment, benefit‑risk evaluation, and cross‑functional collaboration to support early‑access and advanced‑therapy products.

Key responsibilities

• Assess and manage requests under Managed Access Programs and Named Patient Use, integrating clinical and ethical considerations.
• Develop benefit‑risk arguments and ensure compliance with regulatory requirements.
• Collaborate with Regulatory Affairs, Legal, Pharmacovigilance, and Commercial teams to shape access strategies.
• Prepare, review, and own clinical and regulatory documentation, including CTD Modules, expert statements, risk‑management plans, safety reports, and labeling texts.
• Maintain scientific quality across regulatory deliverables, especially for complex products such as ATMPs.
• Support the creation of regulatory strategies, briefing documents, and interactions with global health authorities, including scientific advice procedures.

Required profile

• Medical degree (MD) is mandatory.
• Extensive experience in global drug development and regulatory processes.
• Proven track record across clinical trial phases I‑III, including medical monitoring.
• Background in advanced therapies (e.g., ATMPs or cell therapies) is highly desirable.
• Therapeutic knowledge in oncology, hematology, immunology, or rheumatology.
• Strong scientific writing ability and analytical mindset.
• Fluent English; German language skills are a plus.

Required skills

• CTD authoring (especially Module 2)
• Regulatory documentation (CTD Modules, expert statements)
• Risk Management Plans (RMPs)
• Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
• Labeling texts (SmPC, CCDS, PIL)
• Clinical trial monitoring
• Advanced Therapy Medicinal Products (ATMPs) expertise

What we offer

• Hybrid work model based in Hamburg.
• Full‑time permanent contract.
• Opportunity to work on cutting‑edge therapies within a multinational environment.