MedicalExpert-ClinicalScience

# 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