Medical Expert - Clinical Science (all genders)

HQ medac GmbH; Wedel; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

medac is seeking a Hands-on Medical Expert to drive clinical-scientific and regulatory activities across the product lifecycle. You will develop high-quality regulatory documentation, interpret clinical data, and support global submissions and lifecycle management.

You will translate complex data into clear scientific and regulatory strategies, ensuring consistency across programs. Collaboration with Clinical Development, Regulatory Affairs, Pharmacovigilance and Commercial teams is essential.

Qualifications

• Advanced degree in medicine, pharmacy, pharmaceutical sciences or related medical-scientific discipline.
• Several years of experience in Clinical Development, Medical Affairs, Regulatory Affairs or similar.
• Solid understanding of global drug development, regulatory requirements and lifecycle management.
• Experience in regulatory submission activities, including CTD authoring and Module 2 documentation.
• Experience with cell therapies, MAPs and Named Patient Use (NPU).
• Strong scientific writing and communication skills.
• Fluent in English, some German preferred.

Responsibilities

• Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overviews & Clinical Summaries, Risk Management Plans (RMPs), SmPCs, CCDS, PILs, PSURs/DSURs and other lifecycle 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, 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 MAP and NPU requests and provide evidence-based medical recommendations.
• Contribute to programs involving innovative therapies, including cell therapies and ATMPs.

Skills

Regulatory strategy

Clinical data interpretation

Medical writing

Cross-functional collaboration

Scientific communication

CTD submissions

Education

Advanced degree in Medicine/Pharma/Life Sciences or related field

Job description

About the Role

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 of global submissions and lifecycle management. Acts as a cross-functional scientific partner, translating complex clinical data into clear scientific and regulatory strategies, ensuring consistency across development programs and marketed products. Supports regulatory interactions, benefit-risk assessments and evidence-based decision-making in collaboration with Clinical Development, Regulatory Affairs, Pharmacovigilance and other key stakeholders. Provides 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.

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
• 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, 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/ 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
• Fluent in English, some German preferred

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

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.