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.

Key Responsibilities

• Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overviews & 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), 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, contribute medical expertise to clinical development documents and activities
• Support clinical development programs 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
• Experience with benefit-risk assessments and regulatory interactions
• Solid understanding of global drug development, clinical research, regulatory requirements and lifecycle management
• Experience as Medical Monitor and/or scientific support of clinical trials is desirable
• Experience in the scientific evaluation of licensing opportunities and/or due diligence activities is 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 in English; German is an advantage

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