Medical Expert – Clinical Science

Medical Expert – Clinical Science (all genders)
Wedelnear Hamburg

About medac

We 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 Wedelnear Hamburg, we are looking for aMedical Expert – Clinical Science (all genders).

About the Role
We 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 documents
• Support global regulatory submissions, variations, renewals, and post-approval activities
• Interpret and integrate clinical, safety, and scientific data into robust regulatory and medical-scientific positions
• Contribute to regulatory strategy documents and briefing packages, and support interactions with health authorities, including scientific advice procedures and regulatory meetings
• Ensure scientific consistency, quality, and compliance across submission and lifecycle documentation
• Collaborate cross-functionally with clinical development, regulatory affairs, pharmacovigilance, and commercial functions
• Support benefit-risk evaluations and medical-scientific assessments across the product portfolio
• Evaluate Managed Access Program (MAP) and Named Patient Use (NPU) requests and provide evidence-based medical recommendations
• Contribute to programs involving innovative therapies, including cell therapies and ATMPs

• Advanced degree in medicine, pharmacy, pharmaceutical sciences, life sciences, biomedical sciences, immunology, or a related medical-scientific discipline
• Several years of experience in clinical development, clinical science, medical affairs, regulatory affairs, or a comparable role within the pharmaceutical industry
• Solid understanding of global drug development, regulatory requirements, and lifecycle management
• Demonstrated experience in regulatory submission activities, including CTD authoring and Module 2 documentation
• Experience in cell therapies, Managed Access Programs, and Named Patient Use
• Strong scientific writing and communication skills
• Strong analytical thinking and benefit-risk assessment capabilities
• Ability to translate complex scientific information into clear and actionable recommendations
• Fluency in English; some German preferred

• 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…