Medical Expert - Clinical Science (all genders)

In this role you will lead and evaluate managed access and named patient use requests from a clinical and ethical perspective, ensuring sound benefit–risk rationale. You will produce high-quality regulatory documentation and support global submissions across the product lifecycle, including complex therapies like cell therapies/ATMPs. As a cross-functional clinical partner, you translate clinical data into clear scientific messaging to inform decision-making. You contribute to regulatory strategy and interact with health authorities, shaping access approaches in line with the company’s mission to improve patient outcomes.

• flexible working hours
• remote work option
• 30 annual vacation days
• cafeteria benefits
• attractive salaries and performance-based bonuses
• medac academy training (leadership, coaching, language classes)

• Lead and assess Managed Access Programme (MAP) and Named Patient Use (NPU) requests from clinical and ethical perspectives
• Ensure robust benefit–risk justification and regulatory alignment across documentation
• Interface with regulatory, legal, pharmacovigilance and commercial teams on access strategies
• Author, review and lead regulatory documents (CTD) such as Clinical Overview, Clinical Summary, Risk Management Plans (RMPs), SmPC, CCDS, PIL, PSURs/DSURs and other lifecycle materials
• Ensure scientific consistency and quality across submissions and lifecycle documentation, including for ATMPs/cell therapies
• Contribute to regulatory strategy documents, briefing packages, and global regulatory interactions including scientific advice and Health Authority meetings
• Your Profile
• Medical Doctor
• Strong background in Phase I-III trials, medical monitoring and clinical practice
• Experience in cell therapies/ATMPs, MAP/NPU, and regulatory submissions (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

• MD in Medicine
• Experience in regulatory submissions (CTD authoring, Module 2)
• Clinical trial experience (Phase I–III)
• Background in cell therapies/ATMPs (highly preferred)
• Therapeutic expertise in oncology, hematology, rheumatology or immunology
• Strong medical writing and communication skills
• Analytical thinking and benefit–risk assessment abilities
• Ability to translate science into strategic recommendations

• strong written and verbal communication
• cross-functional collaboration
• problem solving
• CTD authoring
• Clinical Overview & Clinical Summary
• Risk Management Plans (RMPs)