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 RelationshipsundefinedCollaborate 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 ImprovementundefinedMonitor 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 DevelopmentundefinedMentor 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 ManagementundefinedIdentify, 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 completed in a timely manner; (2) Upload and organize all relevant documentation within SharePoint site and ensure audit-ready environment; (3) Identify best practices and operational efficiencies within assigned MAP portfolio; (4) Participate in cross-functional Global MAP meetings to understand and anticipate pipeline products that would be eligible for MAP; (5) Assist medical teams to liaise with Global and/or MRP-TC secretary for all requests that require escalation; (6) Owner of MAP documentation including criteria, application forms, decision letters and training manuals; Partnering with Medical, Legal and Compliance teams to ensure documentation meets patient privacy requirements and disease specific guidelines; (7) Prepare and provide documentation to support audit-related activities to ensure compliance with Sanofi policies & procedures at the local, regional and global level.

• Stakeholders: (1) MAP Operations & Efficiency lead; (2) MAP Governance Leads; (3) Local medical teams; (4) Quality; (5) MRPTC team; (6) Affiliates (7) CMO office  About youExperience:• 12+ years' experience managing projects and stakeholders in life sciences or pharmaceutical organization.• Direct experience in operations management, Project Management and people management.• Experience working across different therapeutic areas is an advantage.• Experience with Managed Access Programs, Compassionate Use (CU), or Expanded Access Programs (EAP) is strongly preferred.

• Good to have –Background in clinical supply chain operations and investigational medicinal product (IMP) distribution from distribution platforms to investigational sites.Previous experience in Quality Assurance, risk management and audits.Experience with pharmacovigilance activities, safety data management, and Safety Data Exchange Agreements (SDEAs). 

• Soft skills:  • Strong understanding of regulatory requirements related to MAP operations management.• Knowledge of GDP/GMP requirements and QA procedures.• Excellent communication skills with demonstrated ability to convey critical information professionally and collaborate with stakeholders and operations teams across multiple geographies.• Advanced skills in Excel, sound knowledge of Outlook, Word, and PowerPoint.• Strong project management, organization, and planning capabilities.• Ability to work independently under pressure and manage multiple stakeholders effectively.• Problem-solving skills and solution-oriented approach in complex matrix environments.• Knowledge of ICH Q7A Good Manufacturing Practice guidelines for active pharmaceutical ingredients and EU Directive requirements.• Understanding of pharmacovigilance inspection processes, including Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), and regulatory compliance requirements.• Familiarity with clinical trial regulations, investigational medicinal product (IMP) management, and auxiliary medicinal product (AxMP) distribution.• Experience with quality management systems, audit preparation methodologies, and CAPA processes in a pharmaceutical environment.• Knowledge of cold chain custody requirements, temperature-controlled distribution, and security of pharmaceutical consignments.

• Technical skills: Proficient MS office skills. Service Now & PowerBI will be a plus.

• Education: Bachelor’s degree in pharmacy or Life Sciences, Advanced degree (Master's/PhD) preferred. Additional certifications in Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), or Pharmacovigilance is an advantage.

• Languages: Excellent knowledge of English language (spoken and written).

• Pursue progress, discover extraordinary, Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN videoand check out our Diversity Equity and Inclusion actions at sanofi.com!