Managed Access Program Manager - maternity leave

Novartis; Milano; Presencial; EUR 45.000 - 84.000; Jornada completa

Descripción de la vacante

The MAP Manager at Novartis Italy leads end-to-end Managed Access Programs, ensuring compliant and high-quality access solutions for patients ahead of or outside commercial availability.

Reporting to the Medical Governance Lead, you will coordinate cross-functional teams, drive logistics, forecasting, and regulatory submissions, and maintain governance and audit readiness while enabling Medical Affairs objectives.

Formación

• Bachelor’s or Master’s degree required in a scientific field.
• Fluency in English and Italian, written and spoken.
• Minimum 5 years of experience in Medical Affairs or related pharmaceutical functions.
• Experience with MAPs, compassionate use, early access, or clinical trial logistics.

Responsabilidades

• Contribute to country strategy and planning for MAPs, providing operational and strategic support.
• Identify and evaluate future MAP opportunities with cross-functional stakeholders.
• Lead operational execution of MAPs, Early Access Programs, and PSDS with compliant processes.
• Develop and implement frameworks for logistics, forecasting, supply management, and labeling.
• Coordinate MAP safety reporting and support regulatory submissions with PV.
• Ensure product availability and timely delivery to sites; manage close-out, transition, or termination.
• Oversee compliance, quality, audit readiness, risk monitoring, and regulatory intelligence.
• Act as key country contact for MAP activities, managing stakeholders, vendors, contracts, KPIs, and process improvements.

Conocimientos

Regulatory coordination

Project management

Vendor management

Data analysis

Communication skills

Educación

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

Descripción del empleo

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. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

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