Medical Scientist (m/w/d)

medac GmbH; Wedel; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Flexible working hours

Job summary

medac GmbH is seeking a Medical Expert - Clinical Science (m/f/d) at Wedel near Hamburg. The role focuses on clinical-scientific and regulatory activities across the product lifecycle, preparing high-quality regulatory documents, interpreting data, and supporting global submissions and lifecycle management.

You will partner with Clinical Development, Regulatory Affairs and Pharmacovigilance, provide medical monitoring for trials, and advise clinical development teams.

Qualifications

• Strong scientific writing and communication skills, including CTD familiarity.
• Know-how in benefit-risk assessments and regulatory interactions.
• Solid understanding of global drug development and lifecycle management.
• Experience as a medical monitor or medical affairs support in clinical trials is desirable.
• Fluent English; German advantageous.

Responsibilities

• Author, review and lead clinical and regulatory documents (CTD) such as Clinical Overviews and Clinical Summaries.
• Interpret and translate clinical data into medical-scientific regulatory positions.
• Provide medical monitoring support for assigned trials and medical guidance to development teams.
• Support MAP and Named Patient Use assessments with benefit-risk evaluation.
• Contribute to scientific evaluations and due diligence for new product opportunities.

Skills

Scientific writing

Communication skills

Cross-functional collaboration

Regulatory interaction knowledge

Medical English

Education

Medical Doctor

Job description

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

Qualifications

• 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 desirablePractice 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

Benefits

Your work-life balance is important to us. We offer flexible worki...