Senior Manager, Medical Affairs – Shockwave International
- Singapore
- Permanent
- Full-time
- Support in development of professional and credible relationships with clinical and scientific thought leaders.
- Interact with KOLs to ensure the execution of international studies within the ISR program in accordance with applicable regulations and SWAV procedures. Serve as point of contact for regional KOLs to facilitate ISR proposal submissions and research contract execution of approved studies. Conduct timely communications with KOLs and internal stakeholders to monitor enrollment and milestone progression of approved ISR studies.
- Provide appropriate clinical and scientific information for Shockwave Medical products and therapeutic areas in response to unsolicited requests for information.
- Attend relevant scientific meetings and conferences in support of SWAV conference activities representing OMA as the subject matter expert and point of contact for scientific information.
- Support in driving communication and education of internal (e.g. commercial, management) and external (e.g. customers, collaborators, distributors) stakeholder on scientific evidence (out of congresses, adboards, funded/sponsored trials)
- Support the International/European Office of Medical Affairs team with scientific expertise when needed
- Be a therapeutic expert and provide scientific support for key regional but also International business partners (Clinical Affairs, Regulatory, Marketing, Professional Education and Market Access).
- Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform SWAV strategic priorities and initiatives.
- Participate in periodic review of clinical reports, abstracts, manuscripts, and other materials related to scientific data and information.
- Supporting global OMA functions cross-functionally with scientific expertise for e.g. carotids, TAVI, PAD, CAD or coronary physiology
- Support Professional Education colleagues in the development and execution of scientific symposia and advisory boards.
- Support as a representative of the director if necessary.
- Ensure that all activities and interactions are conducted with due regard to all applicable local and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice.
- Other duties as assigned.
- Bachelor’s Degree in a scientific field of study. Advance degree strongly preferred (Master, PhD, MD, PharmD, etc.).
- 7+ years of related experience in Medical Affairs in the medical device industries.
- Proficient in English (verbal and written) and at least proficiency in an additional Asian language (e.g. Korean, Chinese, or others).
- Medical device industry experience in cardiovascular medicine with special expertise in carotids, TAVI, PAD, CAD and/or coronary physiology highly preferred.
- Knowledge of international regulations and guidelines including, but not limited to, medical product communications and response to unsolicited requests off-label information.
- Ability to understand, summarize, and convey scientific data in a clear and concise manner.
- Ability to develop and maintain key opinion leader relationships.
- Works effectively independently and on cross-functional teams.
- Effective written, verbal and presentation skills across various audiences.
- Operate as a team or independently while maintaining flexibility and resilience.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Teams, Outlook) software.
- High attention to detail and accuracy, excellent critical thinking skills.
- Good prioritization and organizational skills.
- Entrepreneurial “hands-on” experience. Pro-active and a “can do” attitude.
- Flexible, with a strong ability to work in a fast-paced environment while managing multiple priorities.
- Ability to travel up to 50% of the time depending on business need.