Associate Director, Operations Oversight Lead Medical Affairs Research Global Operations (MARGO)
Core
End-to-end operational oversight of observational studies (NIS) within the Medical Affairs Research portfolio, managing vendors, risks, and timelines to ensure compliant study execution.
Role type
Senior IC Operations Lead (Observational Studies)
Builds
Observational studies and analysis results for internal program/safety decisions and external regulatory/healthcare provider insights
Domain
Life Sciences / Clinical Research / Medical Affairs
Required skills
Vendor management, risk management, project management, cross-functional collaboration, regulatory compliance (GxP), financial oversight, process improvement, stakeholder communication, data-driven problem solving
Preferred skills
Experience with primary and secondary data use studies, knowledge of global NIS regulatory landscape, experience working with international entities
Technologies
GxP compliant study management systems, vendor collaboration platforms
Responsibilities
Track and prioritize execution of observational studies across therapeutic areas; manage vendor performance, issues, and escalation; oversee vendor oversight plans and quality checks; collaborate with scientific leads on study objectives and timelines; monitor study milestones, deliverables, and financials; ensure compliance with regulatory guidelines and process requirements; identify process improvement opportunities; liaise with Quality for periodic reviews.
Seniority
Senior, hands-on IC
