Medical Scientist (m/w/d)

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.

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 worki...