Global Medical Affairs Team Lead

1 giorno fa


Milano, Lombardia, Italia Shockwave Medical, Inc. A tempo pieno
About the Role

The Medical Affairs Senior Specialist - International plays an integral role in supporting the International Medical Affairs team.

Job Summary:

This position provides project and operational management to support the strategic planning and tactical execution of International medical affairs projects, and the investigator sponsored research (ISR) program.

Responsibilities:

  1. Provide day-to-day operational support for the International Investigator-Sponsored Research (ISR) program which includes tracking study proposal submissions through the review and decision process, facilitation of timely research contract review and execution in partnership with Legal and Compliance teams, tracking study enrollment against milestones for approved research studies, and liaising with Finance to monitor the ISR budget as well as Regulatory for documentation updates.
  2. Contribute to identification, building, and maintaining relevant tools to provide real-time monitoring and support for the ISR program and Strategic/Scientific projects.
  3. Provide administrative and project management support for the International Medical Affairs team, including facilitation of vendor contract review and execution, initiation and tracking of purchase orders and invoices, facilitating meeting logistics, and documentation/distribution of meeting minutes for internal and external meetings like advisory boards and team meetings.
  4. Assist with the development, review and implementation of policies, SOPs (Standard Operating Procedures), and work instructions as related to the International Medical Affairs team.
  5. Other duties as assigned.

Requirements:

  • BS Degree or similar, preferably in the life sciences field with 8+ years of experience in Medical Affairs or Clinical Affairs Operations.
  • Proficient in English (verbal and written) and at least one additional major European language (French and/or Italian).
  • Very strong understanding of the Medical Affairs function and investigator-sponsored research programs.
  • Demonstrated experience with project management required.
  • Experience with investigator-sponsored research management systems strongly preferred.
  • Experience with purchase orders, invoicing, and familiarity with Oracle systems as well as contract processing preferred.


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