02 Aug
|
Sandoz
|
Hyderabad
Job Description Summary
Responsible for leading the GCC-based delivery and oversight of worldwide post-approval data generation (DG), worldwide compassionate use (CU) as well as for the Global and Region Europe Medical Affairs team Medical Legal Regulatory (MLR) operations, HCP Engagement operations, and Early Program Biosimilar Pipeline Support with all related responsibilities within the Medical Excellence Operations organization. The role ensures high-quality, compliant, and effective service delivery, drives process consistency and operational governance, and partners with Global Medical Affairs and cross-functional stakeholders to ensure operational delivery, capability building, performance visibility, and continuous improvement.
Job Description
Responsible for leading the GCC-based delivery and oversight of worldwide post-approval data generation (DG), worldwide compassionate use (CU) as well as for the Global and Region Europe Medical Affairs team Medical Legal Regulatory (MLR) operations, HCP Engagement operations,
and Early Program Biosimilar Pipeline Support with all related responsibilities within the Medical Excellence Operations organization. The role ensures high-quality, compliant, and efficient service delivery, drives process consistency and operational governance, and partners with Global Medical Affairs and cross-functional stakeholders to ensure operational delivery, capability building, performance visibility, and continuous improvement.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Drive compliance, quality, and process discipline for post-approval data generation (DG) and compassionate use (CU) activities, including adherence to applicable SOPs / working practices, issue/risk identification, and remediation support where needed. Lead end-to-end delivery and operational oversight of post-approval data generation, including management of global study review, governance and oversight of DG projects to ensure
📌 Associate Director Medical Operations (Hyderabad)
🏢 Sandoz
📍 Hyderabad