Teva Senior Manager Managed Access Programs Operations & Governance 

Croatia, Zagreb 

692481403

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.

• 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

• 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

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.