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
- 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!Apply