PHARMAFull time
Team Lead – Managed Access Program
By Admin · Clinical Research & Clinical Operations
HYDERABAD (IN)ONSITEPOSTED: 10/23/2026
PHARMAFull time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE OVERVIEW
Sanofi Business Operations is hiring a Team Lead to run its Global Managed Access Program operations from Hyderabad, leading the MAP coordinators team across General Medicine and Specialty Care business units. The role covers request intake through product shipment, governance, compliance, pharmacovigilance coordination and team development.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead the Global MAP Coordinators team to deliver end-to-end managed access operations, from product receipt to product shipment, for structured programs and single patient requests across General Medicine and Specialty Care.
- •Oversee request receipt, coordination, approvals and shipment commitments in line with program agreements and regulatory requirements, with governance processes and full traceability and chain of custody in Sanofi systems.
- •Support MAP blueprint development and program initiation, confirming country-level design, operational considerations and execution plans with Medical Product Leaders and transversal teams.
- •Manage preparation and annual review of the MAP Information Package, with validation by the Medical Operations Lead ahead of program initiation and physician training.
- •Coordinate with GBU medical operations, global regulatory, pharmacovigilance and drug safety, quality and risk, supply, clinical supply chain, finance, legal and MRP-TC teams, plus country regulatory managers, country safety heads and regional supply chain managers.
- •Monitor operational KPIs and request processing timelines, conduct business reviews, and drive process, technology and productivity improvements along with oversight of third-party activities and quality agreements.
- •Mentor and develop coordinators through resource allocation, workload management, knowledge sharing and training on eligibility determination, completeness review and workflow confirmation.
- •Manage deviations, risks, CAPA, supplier qualification and audit or inspection support, while overseeing ICSR management, safety signal monitoring and periodic safety reporting.
- •Maintain confidential MAP program documentation for ten years after program closure in the country unless laws require otherwise.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- 12+ years of experience managing projects and stakeholders in a life sciences or pharmaceutical organization
- Direct experience in operations management, project management and people management
PREFERRED QUALIFICATIONS
- •Experience working across different therapeutic areas
- •Experience with Managed Access Programs, Compassionate Use (CU) or Expanded Access Programs (EAP)
- •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)
REQUIRED VERIFIED SKILLS
Regulatory requirements related to MAP operations management
GDP/GMP requirements and QA procedures
Communication skills for conveying critical information across multiple geographies
Advanced Excel; Outlook, Word and PowerPoint
Project management, organization and planning
Ability to work independently under pressure and manage multiple stakeholders
Problem-solving in complex matrix environments
ICH Q10 Pharmaceutical Quality System, ICH Q7A, CAPA, supplier qualification
Pharmacovigilance: ICSRs, safety signal monitoring, periodic safety reporting, Reference Safety Information
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global pharmaceutical company. Sanofi Business Operations, its internal resource organization in India, centralizes processes supporting Specialty Care, Vaccines, General Medicines, Consumer Healthcare, CMO, and R&D, Data & Digital functions.
TEAM SIZE: Approximately 90,000 employees
INDUSTRY: Pharmaceuticals / Biotechnology
APPLICATION ADVISORY
Lead with your 12+ years of project and stakeholder management in life sciences, and make the people-management piece concrete: how you have led a coordinators or operations team, allocated resources and built capability. Highlight any Managed Access Program, Compassionate Use or Expanded Access work, and show GDP/GMP, CAPA, audit and pharmacovigilance exposure. Mention advanced Excel and experience coordinating stakeholders across multiple geographies and functions.
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