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Medical Affairs Manager, Germany

vor 2 Monaten

Frankfurt am Main, Hessen, Deutschland EVERSANA Vollzeit
Job Description

Eversana is seeking a highly skilled Medical Affairs Manager to join our team in Germany. As a key member of our Medical Information and Medical Content Development functions, you will be responsible for ensuring the accuracy, quality, and compliance of medical review of promotional and non-promotional materials.

Key Responsibilities
  • Medical Review and Approval
    • Act as a scientifically responsible person and Final Medical Signatory for Germany, ensuring that promotional and non-promotional materials are disseminated in compliance with relevant codes and regulations.
    • Contribute to the review and approval of country-specific promotional and non-promotional materials for scientific accuracy and compliance with international and local regulations.
    • Review and approve data on file packets, manage planning and prioritization of reviews, and ensure that data are scientifically accurate, contextually correct, and presented in a fair and balanced manner.
  • Medical Affairs Strategy and Support
    • Collaborate with the Head of Medical Content Development and Medical Affairs to develop and implement medical affairs strategies and support the development of key medical affairs deliverables.
    • Oversee assigned client projects, ensuring success and understanding client needs, and act as a liaison with client stakeholders.
  • Regulatory Compliance
    • Maintain detailed and organized records to ensure regulatory compliance and ensure management and compliance with industry standards and codes of practice.
    • Stay informed about the latest developments in pharmaceutical regulations and industry standards.
Requirements
  • Education and Experience
    • Minimum 2 years of experience as a Medical Reviewer or IB.
  • Language Proficiency
    • Fluency in German and English (both written and spoken) is required.
  • Regulatory Knowledge
    • Knowledge of the national case law, the Law on Advertising in the Health Sector (Heilmittelwerbegesetz – HWG), the Law on the Trade in Medicinal Products (Arzneimittelgesetz – AMG), and the Act against Unfair Competition (Gesetz gegen den unlauteren Wettbewerb – UWG).
  • Analytical and Communication Skills
    • Strong analytical and problem-solving skills to evaluate promotional materials and ensure compliance.
    • Exceptional written, oral, interpersonal, and presentation skills, including the ability to effectively interface with health authorities, internal teams, and external stakeholders.
Preferred Qualifications
  • Experience and/or Training
    • 5+ years of experience as a Medical Reviewer of promotional and non-promotional materials.
  • Licenses/Certificates
    • Licensed healthcare professional (physician or pharmacist).
  • Technology/Equipment
    • Experience with Medical Affairs/Medical Information and Medical Review systems (Veeva Vault PromoMats/MedComms), digital solutions, AI.
What We Offer
  • Client Delight
    • Responsible to deliver client delight.
  • Scientific Integrity
    • Uphold the highest standards of scientific integrity and ethical behavior.
  • Collaboration
    • Collaborate effectively with cross-functional teams.