Medical Expert - Clinical Science (all genders)

About the Role
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 of global submissions and lifecycle management.
Acts as a cross-functional scientific partner, translating complex clinical data into clear scientific and regulatory strategies, ensuring consistency across development programs and marketed products. Supports regulatory interactions, benefit-risk assessments and evidence-based decision-making in collaboration with Clinical Development, Regulatory Affairs, Pharmacovigilance and other key stakeholders.
Provides 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.
Key Responsibilities
Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overviews & 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, 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
Your Profile
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/ 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
Fluent in English, some German preferred
Our employees are our greatest asset. And to show our appreciation, we offer attractive benefits:
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 counselling
We promote sports and activities to improve our employees’ health