Medical Expert – Clinical Science (all genders)

medac Gesellschaft für klinische Spezialpräparate mbH; Wedel; Hybrid; EUR 90,000 - 150,000; Full time

Benefits offered by this job

Salary incentives

Medac academy training

Pension plan

Cafeteria

Wellbeing programs

Job summary

medac Gesellschaft für klinische Spezialpraeparate mbH is seeking a Medical Expert – Clinical Science at our Wedel site near Hamburg. You will drive clinical, scientific, and regulatory activities across the product lifecycle, focusing on high‑quality regulatory documentation, data interpretation, and global submissions.

You will act as a cross‑functional scientific partner, translating complex data into clear regulatory strategies, supporting health authority interactions, and ensuring

Qualifications

• Advanced degree in medicine, pharmacy, pharmaceutical sciences, life sciences or related field.
• Several years in clinical development, medical affairs or regulatory affairs in pharma.
• Solid understanding of global drug development and lifecycle management.
• Experience in regulatory submissions and CTD modules.
• Fluency in English; some German preferred.

Responsibilities

• Author and review clinical and regulatory documents (CTD, overviews, PSURs, DSURs, RMPs).
• Support global regulatory submissions, variations, renewals and post‑approval activities.
• Interpret and integrate clinical, safety and scientific data for regulatory positions.
• Contribute to regulatory strategy documents and health authority interactions.
• Ensure scientific consistency and compliance across documentation.
• Collaborate cross‑functionally with clinical development, regulatory and pharmacovigilance.
• Oversee MAP and NPU programs and provide evidence‑based medical recommendations.
• Engage in programs involving cell therapies and ATMPs.

Skills

Global drug development

Regulatory submissions

Clinical development

Medical writing

CTD authoring

Evidence-based decision making

Scientific communication

Cross-functional collaboration

Cell therapies

English fluency

Education

MD/PhD or equivalent

Tools

CTD documentation tools

Medical writing software

Job description

Medical Expert – Clinical Science (all genders)

Wedel near Hamburg 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

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.