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Managed Access Program Manager - maternity leave

IT08 (FCRS = IT008) Novartis Farma S.p.A.

pSalary Range: 45.300,00 € - 84.100,00 € /ph3Job Description Summary /h3pThe 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. /ph3Key responsibilities: /h3ulliContribute to country strategy and planning for Managed Access Programs (MAPs), providing operational and strategic support to Medical Affairs teams. /liliIdentify and evaluate future MAP opportunities in collaboration with Medical, Regulatory, Market Access, Pharmacovigilance, and Supply Chain stakeholders. /liliLead the operational execution of MAPs, Early Access Programs, and Post-Study Drug Supply (PSDS), ensuring compliance with local regulations and Novartis procedures. /liliDevelop and implement operational frameworks covering logistics, forecasting, supply management, product importation, labelling, and distribution. /liliCoordinate MAP safety reporting activities and support regulatory submissions and documentation in partnership with Pharmacovigilance. /liliEnsure product availability, timely delivery to sites, and effective program close-out, transition, or termination processes. /liliManage compliance, quality, audit readiness, risk monitoring, and regulatory intelligence related to access programs. /liliAct as the key country contact for MAP activities, managing stakeholders, vendors, contracts, KPIs, and continuous process improvements. /li /ulh3Essential requirements: /h3ulliBachelor’s or Master’s degree in Pharmacy, Life Sciences, Health Sciences, or a related scientific field. /liliFluency in English and the local language, both written and spoken. /liliMinimum 5 years of experience in Medical Affairs, clinical operations, logistics, regulatory affairs, or related pharmaceutical functions. /liliExperience with Managed Access Programs (MAPs), compassionate use, early access programs, or clinical trial logistics. /liliStrong understanding of pharmaceutical regulations, compliance requirements, and quality standards in regulated environments. /liliProven project management, operational coordination, and vendor management experience. /liliAbility to define, monitor, and analyze KPIs, quality metrics, and operational performance indicators. /liliStrong collaboration, communication, analytical, and organizational skills, with a patient-centric and compliance-focused mindset. /li /ulh3Why Novartis? /h3pOur purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: /ph3Benefits and rewards: /h3pRead our handbook to learn about all the ways we’ll help you thrive personally and professionally: /ph3Commitment to Diversity and Inclusion: /h3pNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. /ph3Skills Desired /h3ulliBudget Management /liliClinical Research /liliClinical Trials /liliCoaching /liliData Analysis /liliData Integrity /liliLearning Design /liliRisk Monitoring /li /ulpImproving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. /ph3In the context of China Cross-Border Data Transfer (CBDT) policy /h3pIn the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov . /p #J-18808-Ljbffr

Offerta di lavoro pubblicata 14 ore fa
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