Medical Expert – Clinical Science (m/f/d)
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 (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 [[fb job category note]] Category: Feste Anstellung