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. 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 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 #J-18808-Ljbffr medac pharma production GmbH