Regulatory Affairs Knowledge Management Capability Lead

This job is with Novartis, an inclusive employer. As a member of the Knowledge & Content Management Platform team, the Knowledge Management Capability Lead contributes to the strategic vision of Regulatory Affairs and supports the digitalization and centralization of Knowledge Management in Regulatory Affairs, by overseeing one or several product(s) underlying the Capability.

The Knowledge Management Capability is supporting knowledge gathering and sharing across the organization, as well as the leveraging of collaboration tools. This capability is defining the strategy for successful deployment and usage of knowledge management technologies, best practices, and advising on information structure. The capability is also supporting regulatory requirements gathering and availability, as well as advocating for a harmonized approach through the leveraging of state-of-the-art enterprise tools. The Capability should also ensure high user adoption & scale-up, and easy retrieval of information potentially leveraging Artificial Intelligence.

The Knowledge Management Capability Lead is accountable to ensure that the Capability strategy delivers business benefits, and to drive harmonization and continuous improvements.

Key Responsibilities

• Responsible to ensure alignment of a team with organizational goals and business priorities related to Knowledge Management.
• Support the strategic vision for the Knowledge & Content Management Platform, from a Capability level.
• Act as a Change Lead to drive system adoption, communication and training, at the capability level: implement change management strategies to ensure smooth adoption of technology initiatives.
• Define, prioritize, and deploy an integrated capability roadmap working in close collaboration with relevant stakeholders and DDIT partners, ensuring alignment with the Knowledge & Content Management Platform, Development and Enterprise technology strategy roadmaps.
• Represent the Capability in digital governance boards and leadership meetings across the organization and in digital networks, externally as needed.
• Communicate effectively to ensure understanding and support for new technology initiatives.
• Support continuous expansion of knowledge and foster the adoption of a digital mindset within the Regulatory Affairs team.
• Oversee vendors at the capability level, across product(s), in collaboration with IT and the External Partnerships Teams.

Essential Requirements

• Must have Regulatory Affairs, Drug Development and Pharmaceutical experience.
• Oversee integrations with products underlying the Capability.
• Ensure on-time, compliant, secure, and quality delivery of portfolio for the assigned capability/product(s), aligned with the NVS Quality Manual.
• Contribute to the change management strategy to ensure smooth adoption of technology initiatives, as required.
• Ensure adherence to Security and Compliance policies and procedures within the scope of the Capability, and prepare for audit readiness and inspection requirements.
• Responsible for Product(s) within the Capability. Can act as a product manager and a product owner.
• Responsible to approve product-related requirements across product(s) underlying the Capability.
• Provide support/resources for key projects and programs with impact to the underlying product(s), ensuring timely delivery of high-quality milestones in alignment with business requirements.

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