Summary
Working model: This location has a hybrid working model (12 days per month in the office)
Note: Novartis is not able to offer relocation support for this role.
About this role:
Leading Managed Access Programs (MAP) and Post Study Drug Supply (PSDS) operations activities with precision and efficiency, our Associate Director, Managed and Post Trial Access Operations makes a substantial contribution to enable access to Novartis products for patients with an unmet medical need. You will be working within a highly collaborative, global team.
About the Role
Major accountabilities:
- Responsible for planning, execution and management of Managed Access Program (MAP) and Post Study Drug Supply (PSDS) operations activities with high quality, adequate resources, timely and cost-efficiently for assigned area/product.
- Lead and oversee implementation, progress, close out activities of assigned MAP and PSDS activities and monitor compliance for reporting.
- Accountable for forecasting and managing drug supply for activity and for activity budget planning, approval, and oversight.
- Accountable for accuracy of MAP and PSDS information in relevant systems.
- Point of contact for MAP and PSDS operational activities for assigned area/product.
- Partner to global and local Medical, Finance, Supply, Quality Assurance, Ethics, Risk & Compliance and other relevant teams to ensure timely, efficient and quality planning and execution of MAP and PSDS activities
- Support process simplification and knowledge sharing with a quality and compliance mind set and drive operational excellence and performance.
- Enable a collaborative and empowered organization that can navigate in a matrix environment and adjust quickly to business needs.
Work Experience and skills:
- Advanced scientific, life science/healthcare degree required.
- At least 5 years technical, operational, or managerial experience in planning, executing and reporting Managed or Post Trial Access or clinical trials in a Pharma company or Contract Research Organization. Experience in Medical Affairs preferred
- Experience in working in matrix organizations and international multidisciplinary teams
- Experience in multiple clinical indications preferred. Previous experience leading several MAPs/PTA/trials in parallel
Skills required:
- Project management expertise
- Strong understanding of clinical development activities and functions/roles/responsibilities
- Advanced understanding of business processes. Thorough knowledge of Good Clinical Practice and global drug development process
- Demonstrated innovation in operational processes and issues resolutions
- Strong interpersonal, problem-solving, negotiation, communication and conflict management/resolution skills
Languages :
- Fluent English both spoken and written
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
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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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.