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Johnson & Johnson is recruiting for Senior Medical Affairs Specialist for Shockwave Medical Inc located in Milan, Italy.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Description
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 experience in the planning, execution, maintenance, and closing of Medical Affairs projects as well as administrative management of the International ISR program.
Essential Job Functions
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 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.
Qualifications
Requirements
BS Degree or similar, with 8+ years of professional experience, preferably in the life sciences field, 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.
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.
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