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Open nowPosted 25 days ago

Medical Expert - Clinical Science (all genders)

medac35 open roles

Where
Headquarter - Wedel
Work mode
Hybrid
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Your applicationOpen nowMedical Expert - Clinical Science (all genders)medac · Headquarter - Wedel

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. medac postings stay open a median of 13 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 25 days ago

medac median: 13 days open

The posting

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
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