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

Summary

Job Description Summary

Join Novartis as a Senior Manager, Managed Access Programs (MAP) & Post-Study Drug Supply (PSDS) Operations and play a vital role in managing patient access to innovative therapies. You will independently manage the planning and execution of these programs, collaborating with global teams to ensure medicines reach those who need them - efficiently, compliantly, and with high quality. Your commitment to operational excellence and attention to detail will help simplify processes and uphold the highest standards, making a meaningful impact on patients and healthcare.

About The Role

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

Location – Hyderabad Hybrid

About The Role :

Join Novartis as a Senior Manager, Managed Access Programs (MAP) & Post-Study Drug Supply (PSDS) Operations and play a vital role in managing patient access to innovative therapies. You will independently manage the planning and execution of these programs, collaborating with global teams to ensure medicines reach those who need them - efficiently, compliantly, and with high quality. Your commitment to operational excellence and attention to detail will help simplify processes and uphold the highest standards, making a meaningful impact on patients and healthcare.

Key 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.

Commitment to Diversity & Inclusion : :

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

Essential Requirements :

Desirable Requirements :

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. How can we achieve this 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

You'll receive : You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. 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.

Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here : https : / / talentnetwork.novartis.com / network.

Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together https : / / www.novartis.com / about / strategy / people-and-culture

Join our Novartis Network : Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up : https : / / talentnetwork.novartis.com / network

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

Skills Required

clinical operations , Medical Affairs, drug development