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Medical Reviewer

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Michael Vrebosch
Recruiter in Herent



Michael Vrebosch
Recruiter in Herent
+32 16 30 95 09


Job description

  • Provide high-level scientific advisory support for claims/ material development, ensuring medical accuracy of scientific content, and compliance with our client's Code of Practice and applicable SOPs.
  • Report accurately the quality-check findings for each reviewed material through internal quality tracking systems.
  • Provide promotional regulatory intelligence to promotional creation stakeholders at the early steps of creation to circumvent quality caveats and accelerate the internal copy approval process.
  • Advocate promotional compliance across the Vaccines organization through strategic partnership and effective cross-functional communication with Commercial and Medical Affairs stakeholders.
  • Build relationship with creation, review and approval stakeholders based on peer collaboration and trust to ensure effective communication around the copy approval process.
  • Liaise with Global Medical Governance team for alignment and advice on potential regulatory challenges impacting the global approval of promotional material.
  • Contribute in collaboration with the management to the development of processes and procedures relevant to the global creation, review and approval of promotional materials; leveraging best practices for quality and agile delivery to the LOCs.

Profile

  • Medical Doctor or PhD, ideally with expertise in Vaccinology, Immunology or Infectious disease.
  • Profound understanding of the drug development process and vaccine clinical trial design, statistics and interpretation.
  • Profound understanding of the drug promotional process and the implicated regulatory framework.
  • Ability to assume sound regulatory acumen and communicate quality findings clearly.
  • Capable of effective, cross-functional communication within matrix, fast-paced, multi-cultural organizations.
  • Collaborative, creative, goal-driven, customer focused and solution-oriented mindset, with high sense of urgency to meet critical deadlines.

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