Senior Manager, Managed Access Programs (MAP) & Post-Study Drug Supply (PSDS) Operations

Our team is part of the Medical Excellence, Operations and Governance team within Development / Global Medical Affairs responsible for the Global Operations for MAPs (Managed access programs | Novartis) and PSDS - one of the Novartis Post-Trial Access solutions.

Responsibilities:                                                                                                                

• Independently coordinate completion of MAP and PSDS strategy plans with input from cross-functional teams.
• Lead operational setup, maintenance, and closure of assigned MAP and PSDS programmes, ensuring oversight.
• Develop, review, submit, maintain, and archive MAP and PSDS documents in relevant systems.
• Provide product and budget forecasts for MAP and PSDS, updating regularly and escalating changes for approval.
• Manage and maintain oversight of the drug supply process for assigned programmes.
• Contribute to safety update reports (DSUR/PSUR) as applicable for MAP and PSDS activities.
• Prepare presentations and supporting documentation to secure operational and financial endorsement.
• Identify, track, and manage risks and issues, proposing mitigation strategies and escalating as needed.
• Collaborate with global and local partners to deliver MAP and PSDS operational activities efficiently and compliantly.
• Support global inspection and audit preparation, conduct quality and internal audits, and assist with corrective actions.

Essential for the role:

• Master’s degree in science; Doctor of Medicine or Pharm D. is a plus.
• Minimum 6 years’ relevant experience in the pharmaceutical industry or public health sector.
• Strong knowledge of medical affairs, clinical operations, or drug development.
• Demonstrated ability to work independently and effectively in global matrix teams and project environments.
• Excellent interpersonal and communication skills across diverse audiences and organisational levels.
• Highly organised, detail-oriented, and able to adapt to changing environments.
• Proficient in Microsoft tools, including SharePoint, Teams, Excel, PowerPoint, and document management systems.
• Excellent English language skills, both written and spoken.

Desirable for the role:

• Experience in working within global organisations and project teams, demonstrating adaptability to change.
• Openness to change and ability to promote a culture of high ethical standards and compliance.

Commitment to Diversity & Inclusion:

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