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, focussed 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.

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), Managed Access Programs/Named Patient Use, Regulatory submission (CTD authoring, Module 2)
• 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
• Language: Fluent English, some German preferred
• Our employees are our greatest asset. And to show our appreciation, we offer attractive benefits:
• Your work-life balance is important to us. We offer flexible working hours with the option of working a proportion of those hours remotely, 30 annual vacation days and an excellent cafeteria
• Attractive salaries and success-based bonuses for all medac employees
• Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes
• A funded pension scheme and other social benefits
• We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling
• We promote sports and activities to improve our employees' health

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