Job Description Summary
Responsible for delivery of Post-approval Data Generation and Compassionate Use and related super user activities within the Medical Excellence Operations organization based out of GCC India. The role ensures high-quality, compliant, and efficient service delivery, supports process consistency and operational governance, and partners with Global Medical Affairs and cross-functional stakeholders to ensure operational delivery, GxP-compliance, Health Authority inspection readiness and continuous improvement across Post-approval Data Generation and Compassionate Use services.
Job Description
Responsible for delivery of Post-approval Data Generation and Compassionate Use and related super user activities within the Medical Excellence Operations organization based out of GCC India. The role ensures high-quality, compliant, and productive service delivery, supports process consistency and operational governance, and partners with Global Medical Affairs and cross-functional stakeholders to ensure operational delivery, GxP-compliance,



Health Authority inspection readiness and continuous improvement across Post-approval Data Generation and Compassionate Use services.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Own end-to-end delivery of Post-approval Data Generation and Compassionate Use, and related operational support activities within defined scope.
Manage study-related and Compassionate Use-related coordination, reporting, documentation, system-based activities, and operational workflows in line with defined processes, GxP-requirements and quality expectations.
Establish and maintain subject matter expertise for related systems and associated workflows, including end user support. Manage user onboarding, training support, process communication, and follow-up trainings related to systems and processes, as applicable.
Establish and maintain subject matter expertise for Post approval Data Generation and Compassionate

📌 Senior Medical Affairs Operations Expert (India)
🏢 Sandoz
📍 India