Medical Expert – Clinical Science (m/f/d)

medac Gesellschaft für klinische Spezialpräparate mbH; Wedel; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Flexible working hours with some hours

30 vacation days per year

Cafeteria benefits

Job summary

medac Gesellschaft für klinische Spezialpräparate mbH is seeking a Medical Expert – Clinical Science (m/f/d) in Wedel near Hamburg. You will drive clinical‑scientific and regulatory activities across the product lifecycle, translating complex data into medical and regulatory conclusions and supporting global submissions and lifecycle management.

You will be a medical advisor to development teams, monitor trials, and contribute to risk assessments, with strong emphasis on CTD documentation and

Qualifications

• MD with several years in clinical development or medical affairs.
• Experience creating regulatory documents (CTD modules).
• Strong scientific writing and data interpretation skills.
• Knowledge of global drug development and regulatory requirements.
• Experience with medical monitoring in clinical trials is a plus.

Responsibilities

• Author, review and lead high‑quality clinical and regulatory documents (CTD).
• Interpret and integrate clinical data into medical‑scientific positions.
• Ensure quality and compliance across submission documents.
• Support benefit‑risk evaluations and medical assessments.
• Evaluate MAP and NPU requests and provide evidence‑based recommendations.
• Provide medical monitoring for assigned trials.
• Advise clinical development teams and contribute to study design and plans.
• Participate in due diligence for new product opportunities.

Skills

Clinical science expertise

Medical writing

Regulatory affairs knowledge

Cross-functional collaboration

English proficiency

Education

Medical Doctor

Job description

Medical Expert – Clinical Science (m/f/d); 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.

About the role

Hands‑on medical expert responsible for clinical‑scientific and regulatory activities across the product lifecycle, with a strong focus on the preparation of high‑quality regulatory documentation, scientific data interpretation, support of global submissions and lifecycle management activities. Acts as a cross‑functional scientific partner, translating clinical and scientific data into clear medical and regulatory conclusions. Contributes to benefit‑risk assessments, evidence‑based decision‑making and health authority interactions in close collaboration with Clinical Development, Regulatory Affairs and Pharmacovigilance. Supports clinical trials through medical monitoring activities and serves as a medical advisor to clinical development teams. Provides medical‑scientific oversight of Managed Access Programs (MAP) and Named Patient Use (NPU) requests, including medical assessment of individual requests and benefit‑risk evaluations to support approval decisions. Participates in scientific evaluations and due diligence activities for new product opportunities, including assessment of clinical data, unmet medical need and benefit‑risk profiles.

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;
• Interpret and integrate clinical and scientific data into robust medical‑scientific and regulatory positions;
• Ensure medical and scientific consistency, quality and compliance across submission and lifecycle documentation;
• 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 to support approval decisions;
• Provide medical monitoring support for assigned clinical trials;
• Serve as a medical advisor to clinical development teams and contribute medical expertise to clinical development documents and activities;
• Support clinical development programmes through scientific input into study design, development plans and evidence‑generation activities;
• Participate in scientific evaluations and due diligence activities for new product opportunities, including assessment of clinical data, unmet medical need and benefit‑risk profiles.

Your profile

• Medical Doctor;
• Several years of experience in clinical development, clinical science, medical affairs, medical monitoring, regulatory affairs or a comparable role within the pharmaceutical industry;
• Strong scientific writing and communication skills, including experience in authoring CTD Module 2.5 and 2.7 documents;
• Know‑how in benefit‑risk assessments and regulatory interactions;
• Solid understanding of global drug development, clinical research, regulatory requirements and lifecycle management;
• Experience as a medical monitor and/or scientific supporter of clinical trials desirable;
• Practice in the scientific evaluation of licensing opportunities and/or due diligence activities preferred;
• Ability to provide medical guidance and translate complex scientific information into clear and actionable recommendations;
• Proactive, collaborative and hands‑on working style with strong cross‑functional communication skills;
• Fluent English; German advantageous.

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 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.

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 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.