Medical Affairs Senior Specialist

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

The Medical Affairs Senior Specialist - International plays an integral role in supporting the International Medical Affairs team. 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. The ideal candidate for this hands-on position is expected to apply coordinator/project management knowledge and strong experience in the planning, execution, maintenance, and closing of Medical Affairs projects as well as administrative management of the International ISR program.

• 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
• Contribute to identification, building, and maintaining relevant tools to provide real-time monitoring and support for the ISR program and Strategic/Scientific projects
• 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, team meetings
• Assist with and drive the development, review and implementation of policies, SOPs (Standard Operating Procedures), and work instructions as related to the International Medical Affairs team.
• Other duties as assigned.

• 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.
• Excellent ability to prioritize, organize, and manage multiple competing assignments and responsibilities.
• Must have high-level of attention to detail and ability to work autonomously while collaborating effectively with other members of Medical Affairs and cross-functional teams.
• Flexible to adapt to changing needs and deadlines.
• Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint) and Smartsheet workflow management software.
• Excellent interpersonal skills with the ability to work well in a team environment.
• Proven ability to develop and maintain a good working relationship with internal and external customers/investigators.
• High-level of personal and professional integrity and ethics.
• Effective written, verbal and presentation skills across various audiences.
• Entrepreneurial "hands-on" experience. Pro-active and "can do" attitude.
• Ability to travel up to 10% of the time.

Benefits
Shockwave Medical offers competitive total compensation packages in line with market requirements.