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
You lead and evaluate medac’s Managed Access Programs (MAP) and Named Patient Use (NPU) requests from a clinical and ethical perspective, ensuring robust benefit-risk assessments and patient-focused decision-making. You are a hands-on Medical Expert responsible for executing clinical-scientific activities across the product lifecycle, focussed on the development of high-quality regulatory documentation (CTD) and support of global submissions and lifecycle management. You act as a cross-functional clinical partner, translating clinical data into consistent scientific messaging and supporting decision-making across clinical science. You bring experience in innovative therapies, including cell therapies, within evolving clinical and regulatory environments.
Medical Expert – Clinical Science (all genders)
Your tasks
- Lead and evaluate medac’s Managed Access Programms (MAP) and Named Patient Use (NPU) requests from a clinical and ethical perspective
- Ensure robust benefit-risk justification, regulatory alignment and high-quality documentation
- Interface with regulatory, legal, pharmacovigilance and commercial stakeholders on access strategies
- Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overview & Clinical Summary, Clinical Expert Statements, Risk Management Plans (RMPs), SmPC, CCDS, PIL, PSURs / DSURs and other lifecycle documents
- Ensure scientific consistency, quality across submissions and lifecycle documentation, including for complex products such as cell therapies / ATMPs
- Contribute to regulatory strategy documents, briefing packages and support global regulatory interactions, including scientific advice procedures and health authority meetings
Your profile
- Medical Doctor required
- Deep understanding of global drug development and regulatory frameworks
- Strong background in Phase I-III trials, medical monitoring and clinical practice
- Demonstrated experience in cell therapies / ATMPs (highly preferred), Managed Access Programs (MAP) / Named Patient Use (NPU) and regulatory submission (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, German preferred
Our offer
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 programs 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
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, personal 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.
Do you have any questions?
Then contact our recruiting team:
Miriam Anderson
Recruiting Manager
04103 8006-8979
m.anderson(at)medac.de
