Life Scientist (m/w/d) (Arzt/Ärztin)

About medacWe are a strong community: with more than 2,000 employees worldwide, we are committed to improving human health. Our work is more than just a job. With a career at medac, you can make a real difference in the industry.

Look into this job opportunity and become part of an exceptional workforce.At our location in Wedel near Hamburg, we are looking for a Medical Expert - Clinical Science (all genders).About the RoleWe are looking for a hands-on Medical Expert responsible for driving clinical, scientific, and regulatory activities across the product lifecycle, with a strong focus on the development of high-quality regulatory documentation, scientific data interpretation, and support for global submissions and lifecycle management.

You will act as a cross-functional scientific partner, translating complex clinical data into clear scientific and regulatory strategies and ensuring consistency across development programs and marketed products. You will support regulatory interactions, benefit-risk assessments, and evidence-based decision-making in collaboration with clinical development, regulatory affairs, pharmacovigilance, and other key stakeholders.

In this role, you will provide medical-scientific oversight of medac’s Managed Access Programs (MAP) and Named Patient Use (NPU) requests, ensuring patient-focused and scientifically robust benefit-risk evaluations.Author, review, and lead high-quality clinical and regulatory documents (CTD), including clinical overviews and clinical summaries, clinical expert statements, Risk Management Plans (RMPs), SmPCs, CCDS, PILs, PSURs / DSURs, and other lifecycle management documentsSupport global regulatory submissions, variations, renewals, and post-approval activitiesInterpret and integrate clinical, safety, and scientific data into robust regulatory and medical-scientific positionsContribute to regulatory strategy documents and briefing packages, and support interactions with health authorities, including scientific advice procedures and regulatory meetingsEnsure scientific consistency, quality, and compliance across submission and lifecycle documentationCollaborate cross-functionally with clinical development, regulatory affairs, pharmacovigilance, and commercial functionsSupport benefit-risk evaluations and medical-scientific assessments across the product portfolioEvaluate Managed Access Program (MAP) and Named Patient Use (NPU) requests and provide evidence-based medical recommendationsContribute to programs involving innovative therapies, including cell therapies and ATMPsAdvanced degree in medicine, pharmacy, pharmaceutical sciences, life sciences, biomedical sciences, immunology, or a related medical-scientific disciplineSeveral years of experience in clinical development, clinical science, medical affairs, regulatory affairs, or a comparable role within the pharmaceutical industrySolid understanding of global drug development, regulatory requirements, and lifecycle managementDemonstrated experience in regulatory submission activities, including CTD authoring and Module 2 documentationExperience in cell therapies, Managed Access Programs, and Named Patient UseStrong scientific writing and communication skillsStrong analytical thinking and benefit-risk assessment capabilitiesAbility to translate complex scientific information into clear and actionable recommendationsFluency in English; some German preferredYour 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 cafeteriaAttractive salaries and success-based bonuses for all medac employeesIndividual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials, and language classesA funded pension scheme and other social benefitsWe care for our employees beyond the workplac...Homeoffice:Umfang: Nach Vereinbarung