Senior Associate, MAP & PSDS Governance

Summary

Independently support development, implementation and maintenance of global standards, policies, guidelines, processes, systems and tools for Managed Access Programs (MAPs) and Post-Study Drug Supplies (PSDS) and their global governance framework.
Support implementation of risk mitigation plans in close collaboration with Novartis Legal, Ethics Risk & Compliance, Internal Audit, Quality Assurance and Patient Safety.

About the Role

Major accountabilities:

• Support the development, implementation and maintenance of Novartis global standards for Managed Access Programs (MAPs) and Post-Study Drug Supplies (PSDS), their internal and external policies, guidelines, procedures, systems and tools according to international guidelines and applicable laws and regulations
• Generate data‑driven insights from MAPs/PSDS to optimize governance
• Support the development and implementation of a global governance framework enabling enterprise-wide central governance and oversight for assigned processes, products and services
• Contribute to continuous improvement for assigned processes, products and services; participate in cross-functional projects to continuously improve Novartis standards, policies, guidelines, processes and systems to ensure better process adherence and to simplify the way we work
• Support identification of quality and compliance risks for Novartis related to assigned areas and establish mechanisms to mitigate these risks
• Support change management and a culture of quality, compliance and patient centricity; identify opportunities for global/local alignment
• Support maintenance and enhancement of internal controls to measure compliance; review internal audit outcomes, perform country exchanges and support country self-assessments based on defined control matrices
• Support country organizations to set-up and execute appropriate corrective and preventive action plans in case of major audit or inspection findings
• Support global inspection and audit preparation and conduct for quality and internal audits. Support corrective actions as required
• Adhere to Novartis values and behaviours, policies, guidelines, procedures, trainings

Minimum Requirements:

• Master's degree in science or clinical operations
• Relevant work experience (approx. 2-4 years) in the pharmaceutical industry or public health sector, in medical affairs, clinical operations or drug development. Good knowledge in relevant governance area
• Good interpersonal skills demonstrating the Novartis values for collaboration, quality and integrity
• Experience in working in matrix teams in global organizations and global project teams
• Good communication skills across different audiences and organizational levels
• Ability to build relationships with internal and external stakeholders
• Openness to change and a culture of high ethical standards and compliance

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

Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
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