Managed Access Program Manager - maternity leave

IT08 (FCRS = IT008) Novartis Farma S.p.A.; Milano; In loco; EUR 45.000 - 84.000; Tempo pieno

Descrizione del lavoro

Novartis Farma S.p.A. is seeking a MAP Manager to coordinate end-to-end Managed Access Programs (MAPs) and other early access initiatives within Italy.

The role requires ensuring compliant, high-quality access solutions for patients outside of commercial availability, under governance and cross-functional alignment. The ideal candidate will have 5+ years in Medical Affairs or related pharma functions, MAPs experience, and strong regulatory knowledge to support submissions and KPI tracking.

Competenze

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Health Sciences, or a related scientific field.
• Fluency in English and the local language, both written and spoken.
• Minimum 5 years of experience in Medical Affairs, clinical operations, logistics, regulatory affairs, or related pharmaceutical functions.
• Experience with Managed Access Programs (MAPs), compassionate use, early access programs, or clinical trial logistics.
• Strong understanding of pharmaceutical regulations, compliance requirements, and quality standards in regulated environments.
• Proven project management, operational coordination, and vendor management experience.
• Ability to define, monitor, and analyze KPIs, quality metrics, and operational performance indicators.

Mansioni

• 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 activities, managing stakeholders, vendors, contracts, KPIs, and continuous process improvements.

Conoscenze

Budget Management

Clinical Research

Clinical Trials

Coaching

Data Analysis

Data Integrity

Learning Design

Risk Monitoring

Formazione

Bachelor’s or Master’s degree in Pharmacy/Life Sciences/Health Sciences

Descrizione del lavoro

Salary Range: 45.300,00 € - 84.100,00 €

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 activities, managing stakeholders, vendors, contracts, KPIs, and continuous process improvements.

Essential requirements:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Health Sciences, or a related scientific field.
• Fluency in English and the local language, both written and spoken.
• Minimum 5 years of experience in Medical Affairs, clinical operations, logistics, regulatory affairs, or related pharmaceutical functions.
• Experience with Managed Access Programs (MAPs), compassionate use, early access programs, or clinical trial logistics.
• Strong understanding of pharmaceutical regulations, compliance requirements, and quality standards in regulated environments.
• Proven project management, operational coordination, and vendor management experience.
• Ability to define, monitor, and analyze KPIs, quality metrics, and operational performance indicators.
• Strong collaboration, communication, analytical, and organizational skills, with a patient-centric and compliance-focused mindset.

Why Novartis?

Our 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: https://www.novartis.com/about/strategy/people-and-culture

Benefits and rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired

• Budget Management
• Clinical Research
• Clinical Trials
• Coaching
• Data Analysis
• Data Integrity
• Learning Design
• Risk Monitoring

Improving 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.

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In 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 .