Global Medical Review Lead

hace 7 días


Barcelona, Barcelona, España Onesolar A tiempo completo
Job Summary

The Global Medical Review Lead will serve as the medical delegate on the International Medical, Legal, and Regulatory (MLR) review committee, responsible for reviewing and approving promotional and medical/scientific materials containing information on Alexion's marketed products and compounds in development. This role requires a high level of expertise in medical review and medical information, scientific acumen, and cross-functional collaboration.

Key Responsibilities
  • Collaborate with Global Medical Affairs Leads and Medical Directors to ensure alignment of company medical strategy.
  • Review materials to ensure data is accurate, within context, and presented in a fair/scientifically balanced manner.
  • Verify the substantiation of all claims and comparisons.
  • Liaise with functional leaders to operationalize robust and compliant procedures for the MLR review process.
  • Develop an expert understanding of product data and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, and marketing strategies and tactics across Alexion's therapeutic areas.
  • Work closely with GMI-MR team members, regional Medical Affairs, Commercial, Legal, Regulatory, Quality, and Drug Safety teams.
Requirements
  • Excellent oral and written communication skills.
  • Customer focus and teamwork.
  • Previous participation in audits is a plus.


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