Medical Expert - Clinical Science (all genders

About the Role

Leads and evaluates medac’s Managed Access Programs (MAP) and Named Patient Use (NPU) requests from a clinical and ethical perspective, ensuring robust benefit–risk assessments and patient-focused decision-making. Hands‑on Medical Expert responsible for executing clinical–scientific activities across the product lifecycle, focused on the development of high–quality regulatory documentation (CTD) and support of global submissions and lifecycle management. Acts as a cross–functional clinical partner, translating clinical data into consistent scientific messaging and supporting decision–making across Clinical Science.

Brings experience in innovative therapies, including cell therapies, within evolving clinical and regulatory environments.

• Lead and evaluate medac’s Managed Access Programme and Named Patient Use (NPU) requests from a clinical and ethical perspective.
• Ensure robust benefit–risk justification, regulatory alignment and high–quality documentation.
• Interface with regulatory, legal, Pharmacovigilance and commercial stakeholders on access strategies.
• Author, review and lead high–quality clinical and regulatory documents (CTD), including Clinical Overview & Clinical Summary, Clinical Expert Statements, Risk Management Plans (RMPs), SmPC, CCDS, PIL, PSURs / DSURs and other lifecycle documents.
• Ensure scientific consistency, quality across submissions and lifecycle documentation, including for complex products such as cell therapies / ATMPs.
• Contribute to regulatory strategy documents, briefing packages and support global regulatory interactions, including scientific advice procedures and Health Authority meetings.

• Medical Doctor required.
• Deep understanding of global drug development and regulatory frameworks.
• Strong background in Phase I–III trials, medical monitoring and clinical practice.
• Demonstrated experience in cell therapies / ATMPs (highly preferred).
• Experience with Managed Access Programs/Named Patient Use, Regulatory submission (CTD authoring, Module2).
• Therapeutic expertise in oncology, hematology, rheumatology or immunology.
• Exceptional medical writing and storytelling capability.
• Strong analytical thinking and benefit–risk assessment skills.
• Ability to translate complex science into clear strategic recommendations.
• Fluent in English; some German preferred.

• Flexible working hours with the option of working a proportion remotely.
• 30 annual vacation days and an excellent cafeteria.
• Attractive salaries and success–based bonuses for all medac employees.
• Individual training opportunities: leadership training, coaching essentials and language classes via medac Academy.
• Funded pension scheme and other social benefits.
• Support for caring for elderly relatives and counseling services.
• Sports and activities to improve employee health.

With more than 2,000 employees worldwide, medac is committed to improving human health. A career at medac means more than just a job; you can make a real difference in the industry.