Medical Expert – Managed Access & Regulatory Strategy

About the role

We are seeking a Medical Expert to lead the assessment and management of requests within Managed Access Programs and Named Patient Use frameworks. The role combines clinical insight, ethical judgment, and regulatory expertise to shape access strategies for innovative therapies.

Key responsibilities

• Assess and manage Managed Access and Named Patient Use requests, integrating clinical and ethical perspectives.
• Develop benefit‑risk arguments while ensuring compliance with global regulatory requirements.
• Collaborate with Regulatory Affairs, Legal, Pharmacovigilance, and Commercial teams to define access strategies.
• Prepare, review, and own clinical and regulatory documentation, including CTD Modules (Clinical Overview, Clinical Summary), expert statements, risk management plans, safety reports (PSUR/DSUR), and labeling texts (SmPC, CCDS, PIL).
• Maintain scientific quality and consistency across regulatory deliverables, especially for advanced therapy medicinal products (ATMPs).
• Support the creation of regulatory strategies, briefing documents, and interactions with health authorities, including scientific advice procedures.

Required profile

• Medical degree (MD) required.
• Extensive experience in global drug development and regulatory processes.
• Proven track record across clinical trial phases I‑III, including medical monitoring.
• Therapeutic knowledge in oncology, hematology, immunology, or rheumatology.
• Fluent English; German language skills are a plus.

Required skills

• CTD Module authoring (especially Module 2).
• Regulatory documentation preparation (RMP, PSUR, DSUR, SmPC, CCDS, PIL).
• Scientific writing and benefit‑risk evaluation.
• Advanced therapy (ATMP) expertise.
• Clinical trial monitoring and medical oversight.