02 ott - Milano
IT08 (FCRS = IT008) Novartis Farma
Salary Range: 45.300,00 € - 84.100,00 €
Se i requisiti e l'esperienza richiesti per questo lavoro corrispondono alle sue competenze, la preghiamo di candidarsi tempestivamente.
Job Description Summary
The MAP Manager is responsible for the end to end coordination and operational execution of Managed Access Programs (MAPs) and other early or compassionate access programs within the country. The role contributes to defining and implementing compliant, high quality access solutions for patients prior to or outside of commercial availability, in line with local regulations and Novartis standards. Reporting to the Medical Governance Lead and Scientific Service Manager, the MAP Manager ensures that all MAP related activities are executed with strong governance, audit readiness, and cross functional alignment, while enabling Medical Affairs strategy execution without holding final governance approval authority.
Key responsibilities:
- Contribute to country strategy and planning for Managed Access Programs (MAPs), providing operational and strategic support to Medical Affairs teams.
- Identify and evaluate future MAP opportunities in collaboration with Medical, Regulatory, Market Access, Pharmacovigilance, and Supply Chain stakeholders.
- Lead the operational execution of MAPs, Early Access Programs, and Post-Study Drug Supply (PSDS), ensuring compliance with local regulations and Novartis procedures.
- Develop and implement operational frameworks covering logistics, forecasting, supply management, product importation, labelling, and distribution.
- Coordinate MAP safety reporting activities and support regulatory submissions and documentation in partnership with Pharmacovigilance.
- Ensure product availability, timely delivery to sites, and effective program close-out, transition, or termination processes.
- Manage compliance, quality, audit readiness, risk monitoring, and regulatory intelligence related to access programs.
- Act as the key country contact for MAP activiti
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