Medical Expert – Clinical Science (all genders)

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 Wedel near Hamburg, we are looking for a Medical 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.

Your tasks

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

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, 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

Contact

Are you looking for a new professional challenge and a job with a meaning? Become part of medac’s internationally growing team, and let’s make a difference together. We are looking forward to receiving your online application! After applying, please check your spam folder and add us and our applicant management software “Workday” to the list of trusted senders. Thank you very much. We want everyone to feel included and welcome, and we treat everyone equally. We welcome all applications, regardless of age, gender, sexual identity, nationality, religion, ideology, ethnic and social background or disability. Anyone who is part of medac is part of a diverse – and therefore strong – team.

Apply now

Do you have any questions? Then contact our recruiting team:

Miriam Anderson Recruiting Manager 04103 8006-8979 m.anderson@medac.de