ResponsibilitiesThe Sr. Medical Affairs Specialist will support cross-functional and cross-regional alignment of medical operations and deliverables ensuring strong local execution of global strategy and contributing to operational improvements that enhance internal collaboration, data collection, and compliance.
Key Responsibilities- Lead handling and processing of ALL investigator-initiated research (IIS) coordination and real-world data collection
- Lead the medical education grant program
- Serve as a key partner with other team members to optimize MedInfo process
- Translate scientific, regulatory, and clinical insights into actionable plans across product lifecycles.
- Support Post market activities in collaboration with key functions such as quality, regulatory, compliance/legal (e.g., risk management, health hazard evaluations, complaint review support registry study data flow, adverse event tracking)
- Partner with clinical development to align pre- and post-market data strategy.
- Partner with Scientific Communications and cross-functional teams to support any requested scientific material development or review
- Ensure adherence to SOPs, ethical guidelines, and regional regulations
- Support leadership in development of desired metrics and dashboards to track impact of medical strategy execution.
- Serve as a subject matter expert in relevant therapeutic areas (e.g., vascular access, interventional cardiology, structural heart), maintaining current and comprehensive knowledge of clinical data, regulatory trends, and competitor positioning
- Collaborate with global and regional stakeholders to optimize Medical Affairs workflows, including processes, systems, platforms and or document management
- Serve as a bridge between global and regional teams including regional medical affairs team mates ensuring alignment on execution and priorities.
- Act as the point of contact for the assigned region for internal stakeholders and identify areas of support in aspects of key product launches, handling off label queries, unsolicited KOL queries and communicate insights to global Medical Affairs leadership. Develop solutions for the same.
Qualifications- Degree in life sciences, medicine, pharmacy, nursing, or biomedical engineering (Bachelor's required; Master's/PharmD/PhD a plus)
- 5+ years of experience in the medtech or pharmaceutical industry or 3+ years of experience w/ a Master's degree
- Demonstrated ability to manage complex operations and collaborate cross-functionally
- Strong organizational and communication skills
- Proven organizational and project management skills.
