Clinical Science Medical Expert — MAP/NPU & Regulatory

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.

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), Managed Access Programs/Named Patient Use, Regulatory submission (CTD authoring, Module 2)

• Therapeutic expertise in oncology, hematology, rheumatology or immunology

• Exceptional 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