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.

Key Responsibilities

• 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.

Your Profile

• 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.

Benefits

• 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.

About Medac

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.