Team Lead Managed Access Program

Role: Team Lead – Managed Access Program % of travel expected: Travel required as per business need, if any Job type: Permanent and Full time     About the job: Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. Sanofi Business Operations (SBO) strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ in Sanofi, globally. The Sanofi Business Operations (SBO) is built to reduce reliance on external services providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage untapped combination of talent pool. ·       Main Responsibilities • Lead and manage the Global MAP Coordinators (GMCs) team to deliver end-to-end MAP operations from product receipt through to product shipment for both structured programs and single patient requests across General Medicine and Specialty Care GBUs. • Oversee MAP Operational Excellence • Monitor and ensure timely request receipt, coordination, approval and product shipment commitments in accordance with program agreements and regulatory requirements. • Establish and maintain robust processes for operations governance. • Ensure full traceability and chain of custody through appropriate recording in Sanofi systems and tools. • Drive adherence to GDP/GMP requirements and quality standards throughout MAP operations. • Oversee MAP blueprint development and program initiation processes, ensuring Medical Product Leaders initiate discussions with identified MAP transversal teams to obtain detailed operational information confirming design, operational considerations, and execution plans per country in scope. • Ensure compliance with material segregation and traceability requirements to maintain product integrity throughout the distribution chain. • Manage MAP Information Package preparation and annual review processes to verify current versions of all materials, ensuring the Medical Operations Lead validates the MAP Information Package prior to program initiation and physician training • Manage Stakeholder Coordination and Relationships undefinedCollaborate effectively with GBU Medical Operation teams, Global Regulatory Manager, Global Pharmacovigilance (PV) and Drug Safety teams, Quality and Risk Managers, Supply Leaders, Clinical Supply Chain Operations, Global Finance, Global Legal and MRP-TC teams.Establish strong partnerships with Healthcare Professionals and patient advocacy groups as end beneficiaries of MAP programs.Facilitate cross-functional alignment and resolve operational challenges.Coordinate with Country Regulatory Managers for application submissions to local Regulatory Authorities and management of approvals, including notifications of registration status and program closure requirements.Collaborate with Country Safety Heads (CSH) to ensure Global PV database configuration, safety reporting compliance, and local safety training requirements are met.Work with Local/Regional Supply Chain Managers to determine supply feasibility and coordinate commercial product supply when applicable, including patient transfer to commercial pathway upon Marketing Authorization and Reimbursement. ·       • Drive Operational Performance and Continuous Improvement undefinedMonitor MAP operational KPIs and metrics to proactively identify and resolve potential challenges.Conduct periodic business reviews with relevant stakeholders to assess program performance.Identify and implement opportunities for process optimization, technology enhancement, and productivity improvements.Lead continuous i