Senior Manager Managed Acces Program (MAP)

The Glocal Resource; Pune District; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

The Glocal Resource seeks a Senior Manager to lead Managed Access Programs (MAP) operations and governance. You will own MAP processes, coordinate cross-functional teams, and ensure compliance across regulatory and ethical standards globally.

You will collaborate with internal and external stakeholders to drive timely MAP reviews, training, and SOP updates while supporting Post-Trial Access and compassionate use initiatives.

Qualifications

• Bachelor's degree in Biomedical Sciences, Pharmacy or similar.
• 5 years of industry experience in medical affairs or clinical trials, MAPs preferred.
• Strong interpersonal, project management, and organizational skills.

Responsibilities

• Oversee MAP intake, review, execution, oversight, governance, and tracking globally.
• Serve as MAP Subject Matter Expert and provide training on MAPs.
• Ensure regulatory and ethical alignment across global, regional, and local levels.
• Own systems supporting MAPs and ensure efficient operation and compliance.
• Collaborate with stakeholders to facilitate timely MAP reviews and execution.
• Maintain review timelines and ensure drug supply availability.

Skills

MAP expertise

Project management

Regulatory knowledge

SOP development

Vendor coordination

Education

Bachelor's in Biomedical Sciences or Pharmacy

Tools

Clinical trial management system

Job description

Opportunity for a Driven Senior Manager Managed Access Programs (MAP) at The Glocal Resource.

At The Glocal Resource, we redefine how businesses operate and grow in our interconnected global landscape. Established with a vision to bridge local expertise with global opportunities, we specialize in providing innovative outsourcing solutions. Since our inception in 2019, we have become a trusted partner for businesses around the world, helping them navigate the complexities of the modern workforce.

Job Description

Title: Senior Manager Managed Access Programs (MAP)

The opportunity

This role will support Managed Access Programs (MAPs) a crossed R&D, including but not limited to Compassionate Use Programs (CUPs) and Post-Trial Access (PTA) by supporting the intake, review, execution, operational support, oversight, and governance of MAPs.

As the business owner of MAPs and the required systems the Senior Manager, Managed Access Programs Operations & Governance will collaborate with internal and external stakeholders to facilitate planning, as well as timely program reviews and execution, including maintaining review timelines and drug supply availability. Additionally, this role will support program compliance by maintaining policies, Standard Operating Procedures (SOPs), Work Instructions, and other procedural documents while overseeing quality, inspection readiness activities, and employee training. This position will be responsible for adhering to policies and SOPs essential for compliance.

How You’ll Spend Your Day

• Oversee global processes for MAPs intake, review, execution, oversight, governance, and tracking
• Serve as the MAP Subject Matter expert, including evaluation and maintaining knowledge on all aspects of MAPs as well as provide relevant training
• Ensure alignment with regulatory and ethical standards across global, regional, and local levels
• Serve as the business owner for systems supporting MAPs, ensuring efficient operation and compliance
• Collaborate with internal and external stakeholders to facilitate timely reviews and execution of programs
• Maintain oversight of review timelines and work with internal stakeholders to ensure drug supply availability
• Develop, update, and enforce policies, SOPs, Work Instructions, and procedural documents essential for compliance
• Lead quality initiatives, inspection readiness activities, and employee training relevant to MAPs processes.
• Provide operational support for regional and local Medical Affairs teams to assist with MAPs activities, e.g. SDC/protocol development, vendor selection, convene MAPs review team, prepare and support MAPs training presentations
• Support the Global Clinical Operations group as needed for operationalization of Post-Trial Access
• Facilitate knowledge sharing, status updates and critical issue identification
• Provide support for GMA Study Ops & Governance initiatives as requested
• Provide system support (clinical trial management system, intake portals) as needed

Your Experience And Qualifications

• Bachelor’s degree in Biomedical Sciences, Pharmacy or similar
• 5 years of experience in Industry with relevant medical affairs experience and/or clinical trial experience. Experience with managing MAPs is strongly preferred.
• Strong interpersonal skills with experience in project management, organization and tools
• 7 years of experience in Industry with relevant medical affairs experience and/or clinical trial experience including MAPs experience
• Knowledge of Good Clinical Practice and Good Pharmacovigilance Practice
• Understanding of how to navigate local regulatory environment as related to MAPs
• Pharmaceutical experience including understanding of Medical Affairs including clinical trials(e.g. MAPs including CUPs and Post-Trial Access)
• Excellent interpersonal and communication skills, able to build strong working relationships with all stakeholders involved (Internal and external business partners)
• Able to work in a changing and flexible environment in an adaptive way with a “can-do” positive attitude and acts in a capacity where the individual’s wide-ranging experience will add to the quality and outcome of business decisions
• Experienced and adept at working collaboratively across different cross-functional teams such as R&D, health outcomes, regulatory, pharmacovigilance and compliance/legal
• Experienced and comfortable working in a matrix set up, facilitating desired outcomes by integrating business partners from various regions with different personal background
• Able to adopt a different working style when needed and dictated by a changing working environment (changing business needs and context)
• Strong problem identification and resolution skills with demonstrated ability to apply technology and process solutions for business related problems or opportunities
• Solid knowledge of project management, organization and tools, requires strong attention to details
• Managed Access Program experience such as Post-Trial Access and Compassionate Use
• Clinical Studies management experience