Summary
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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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
