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At our location in Wedel near Hamburg, we are looking for a Medical Expert – Clinical Science (m/f/d).

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.

• 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

• 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 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

Category: Feste Anstellung