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 improvement initiatives in collaboration with Medical Operations and GBU teams.Implement and monitor performance metrics for request processing timelines, including acknowledgement of Program Terms and Conditions, data privacy notices, physician eligibility confirmation, and patient eligibility confirmation.Establish oversight mechanisms for third-party activities and ensure quality agreements are in place with contract givers and service providers to specify quality requirements and define respective responsibilities and commitments. Provide Team Leadership and Development undefinedMentor GMC team members in establishing robust MAP operational processes and expertise.Ensure effective resource allocation and workload management across the team.Drive knowledge sharing, best practices implementation, and capability building within the team.Manage team performance and remove impediments affecting operational delivery.Provide training and development on MAP request assessment processes, including eligibility determination, completeness review, and workflow confirmation based on product lifecycle stage, existence of pre-established Medical Eligibility Criteria, and alliances with other partners. Ensure Compliance and Risk Management undefinedIdentify, escalate, and manage deviations and risks associated with MAP Request management.Ensure adherence to international regulatory requirements and Sanofi policies.Support audit preparations and respond to regulatory inspections as required.Ensure compliance with documentation retention requirements, maintaining confidential MAP program documentation for a period of ten (10) years after program closure in the country, unless applicable laws and regulations require otherwise, and ensure prior notification to Sanofi before destroying any essential documents related to a MAP request.Implement and oversee pharmacovigilance requirements including Individual Case Safety Reports (ICSRs) management, safety signal monitoring, periodic safety reporting, and maintenance of Reference Safety Information in alignment with regulatory pharmacovigilance obligations.Ensure all MAP activities comply with ICH Q10 Pharmaceutical Quality System requirements and current Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) guidelines.Manage Corrective and Preventive Actions (CAPA) processes to correct deviations and prevent recurrence across MAP operations.Oversee supplier qualification processes, maintain quality management systems for all MAP-related activities, and ensure subcontractor management procedures are in place for all third-party service providers. People : (1) Primary point of contact for local medical teams globally for MAP questions, case submissions, process inquiries etc.;(2) Responds to internal and external inquiries regarding Sanofi or Affiliate MAP (3) Liaise and coordinate with colleagues from Global & Local medical teams, Project Management team, and Quality; (4) Provide reporting and MAP program updates (as needed) to global medical teams (5) Maintain Global contacts lists for MAP communications · Performance : (1) Ensure deliverables meet the required timelines, quality targets and adhere to the compliance requirements;(2) Managing MAP requests related documents timely storage and retrieval; (3) Escalating MAP requests to MRPTC process and managing the documentation (4) Timely sharing the MRPTC meeting notes to all the relevant stakeholders with appropriate actions; (5) Adhering to affiliate process while processing affiliate requests · Process : (1) Receive and track all MAP requests for assigned portfolio ensuring evaluation and response to requesting physician are comp