Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.
Responsibilities:
The 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.
Preferred Qualifications:
Experience supporting regional teams (e.g., APAC, EMEA) is preferred
Excellent communication, leadership, and strategic thinking skills.
Comfortable in a dynamic, fast-paced, and matrixed environment.
Attention to detail.
Proficiency in Microsoft Office.
Team player with a "can-do" attitude.
Numbers & Facts
Location
Florida
Job Type
Full-time
Skills
Adverse Eventsunmatched
Biologyunmatched
Biomedical Engineeringunmatched
Biotech and Pharmaceuticalunmatched
Cardiologyunmatched
Cardiovascular Diseaseunmatched
Clinical Dataunmatched
Clinical Practices/Protocolsunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Data Collectionunmatched
Detail Orientedunmatched
Document Managementunmatched
Drug Developmentunmatched
Drug Productsunmatched
Healthcareunmatched
Leadershipunmatched
Legalunmatched
Marketing Strategyunmatched
Medical Affairsunmatched
Medicineunmatched
Metricsunmatched
Microsoft IIS Web Server (Internet Information Services)unmatched
Microsoft Officeunmatched
Nursingunmatched
Operational Improvementunmatched
Operations Managementunmatched
Organizational Skillsunmatched
Pharmacyunmatched
Procedure Implementationunmatched
Process Improvementunmatched
Product Lifecycleunmatched
Product Planningunmatched
Product/Service Launchunmatched
Project/Program Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Reporting Dashboardsunmatched
Risk Managementunmatched
Team Playerunmatched
Trend Analysisunmatched
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