Sandoz
Website:
sandoz.com
Job details:
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.
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 Use end user support, tools, reporting, and operational processes. Support governance and oversight of post-approval data generation activities and defined workflows, including documentation and reporting requirements.
- Manage Compassionate Use operational support activities, including request-related coordination, system end user support, reporting, documentation, and stakeholder follow-up.
- Support Training Responsible Person (TRP)-related activities and contribute to training coordination, tracking, reporting, and operational readiness, as applicable. Drive process discipline for defined GxP-relevant activities, including adherence to applicable SOPs / working practices, issue/risk identification, and remediation support where needed.
- Partner with Global Medical Affairs, Technology, Clinical Development, Quality, Safety, Regulatory, and other relevant stakeholders to align priorities, resolve issues, and drive continuous improvement across the service model.
- Deliver metrics, reporting inputs, and service indicators to support oversight, performance visibility, and continuous improvement.
- Support the transition and stabilization of services into GCC and contribute to process standardization, documentation, and operational maturity.
Essential Requirements
What you’ll bring to the role:
- Post-approval Data Generation Compassionate Use, and related operational support activities are delivered effectively and in line with GxP, defined quality, compliance, and service expectations.
- Post-approval Data Generation related and Compassionate Use-related reporting, and documentation are delivered accurately and within agreed timelines.Act as system super user and support system testing (as needed).
- Operational support for defined GxP-relevant activities is well coordinated and supported by appropriate process discipline and stakeholder alignment.
- System end user support, training, user enablement/management, reporting, and are delivered consistently and in line with defined service expectations.
- Identified risks / gaps are addressed in a timely manner, with appropriate remediation and continuous improvement actions.
- Education: Advanced degree or equivalent qualification in life science, healthcare, pharmacy, medicine, or related field preferred with 8–12+ 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.
- Subject matter expertise in Clinical Operations and Compassionate Use workflows, reporting, systems support, documentation, and medically relevant operational processes.
Desirable Requirements
- Aim for two bullet points
- Aim for two bullet points
You’ll 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 world’s 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.
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