01Overview
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.
Essential Requirements
What youll 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 58+ 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.
Youll Receive
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the worlds medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
Commitment To Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. .
