Medical Affairs Operations Expert

Sandoz India; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sandoz India in GCC India region seeks a seasoned professional to support Post-approval Data Generation, Compassionate Use, and related operational activities. You will ensure GxP-compliant, well-documented execution, maintain records, and coordinate with global teams to drive continuous improvement in Medical Affairs operations.

The role requires 5–8+ years in pharma/healthcare, strong documentation and cross-functional collaboration, and system-based support across processes, ensuring

Qualifications

• Advanced degree or equivalent qualification in life science, healthcare, pharmacy, medicine, or related field preferred.
• 5–8+ years experience in the pharmaceutical/healthcare industry, ideally with Medical Affairs operations, Compassionate Use, post-approval data generation, and related support models.
• Good understanding of GxP, quality and service expectations.
• Experience working in a cross-functional and global environment.

Responsibilities

• Support delivery of Post-approval Data Generation, Compassionate Use, and related operational support activities within defined processes and workflows.
• Support coordination, reporting, documentation, and system-based activities within scope.
• Maintain trackers, records, reports, and operational archives in line with defined process expectations across Post-approval Data Generation and Compassionate Use activities.
• Act as super user for related systems and support system testing, data entry, reporting, and end user support.
• Support Training Responsible Person (TRP)-related activities, training tracking, reporting, and operational coordination.
• Contribute to process standardization, knowledge sharing, and continuous improvement across the service model.
• Support transition and stabilization of services into GCC and contribute to operational maturity.

Skills

GxP compliance

Documentation

Cross-functional teamwork

System testing

Data generation

Education

Advanced degree in life sciences/healthcare/pharmacy/medicine

Job description

Job Description:

Responsible for supporting Post-approval Data Generation, Compassionate Use, reporting, systems-related activities, and related operational support within the Medical Excellence Operations organization based out of GCC India. The role ensures accurate, timely, and well-documented execution of core operational activities and supports process consistency, 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:

• Support delivery of Post-approval Data Generation, Compassionate Use, and related operational support activities within defined processes and workflows.
• Support Post-approval Data Generation-related and Compassionate Use-related coordination, reporting, documentation, and system-based activities within scope.
• Maintain trackers, records, reports, and operational archives in line with defined process expectations across Post-approval Data Generation and Compassionate Use activities. Support request-related coordination, mailbox / query handling, stakeholder follow-up, and other defined operational support activities, as applicable.
• Act as super user for related systems und support system testing (as needed). Support systems-related activities, including data entry, reporting support, end user support, and documentation maintenance within defined workflows.
• Support Training Responsible Person (TRP)-related activities, training tracking, reporting, and operational coordination, as applicable. Contribute to accurate and timely execution of operational workflows and related documentation.
• Support process standardization, knowledge sharing, and continuous improvement across the service model.
• Support the transition and stabilization of services into GCC and contribute to operational maturity.

What you’ll bring to the role:

• Post-approval Data Generation, Compassionate Use, and related operational activities are completed effectively and in line with GxP, defined quality and service expectations.
• Reports, trackers, records, and system-based documentation are maintained accurately and within agreed timelines.
• Request-related and study-related coordination activities are completed accurately and supported by appropriate process discipline.
• Team delivery remains consistent, well documented, and supported by stakeholder coordination and timely follow-up.
• Identified issues / gaps are addressed in a timely manner, with appropriate follow-up and continuous improvement actions.
• Education: Advanced degree or equivalent qualification in life science, healthcare, pharmacy, medicine, or related field preferred with 5-8+ years experience in the pharmaceutical / healthcare industry, ideally with experience in Medical Affairs operations, Clinical Operations support, Compassionate Use support, post-approval data generation, and related support models.
• Good understanding of Clinical Operations and Compassionate Use workflows, reporting, documentation, systems-related support, and medically relevant operational processes.
• Experience working in a cross-functional and global environment.

You’ll Receive

Breakdown of benefits received in this role