Medical Expert – Clinical Science (all genders)

• 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

Our offer

• 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 counseling
• We promote sports and activities to improve our employees’ health