Belgique 16.04.2021

Medical Reviewer

Tasks

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany and Czech Republic.

 We are currently looking for a Medical Reviewer to drive the critical role of reviewing promotional materials and regulatory compliance. The activities include (but not limited to):

  • Provide high-level scientific advisory support for claims/ material development, ensuring medical accuracy of scientific content, and compliance 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.
  • 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 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.
  • Advocate promotional compliance across the Vaccines organization through strategic partnership and effective cross-functional communication with Commercial and Medical Affairs stakeholders

Requirements

Requirements:

  • MD or PhD. degree
  • Fluent English (French is a plus)
  • Around 3 years of experience from pharma industry (exp. from Vaccinology, Immunology or Infectious disease is a plus)
  • Profound understanding of the drug development process and vaccine clinical trial design, statistics and interpretation and of the drug promotional process and the implicated regulatory framework
  • Great communication skills

Does this sound exciting to you? If so, we look forward to meeting you!

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