Regulatory Affairs Knowledge Management Capability Lead

Job Description Summary
Job Description Summary
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 an 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.

Job Description

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 (e.g. across Industries) 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 (incl. Related mitigations or actions triggered by audits & inspections).
• Responsible for Product(s) within the Capability. Can act as a product manager and a product owner
• Ensure on time, compliant, secure, and quality delivery of portfolio for the assigned product(s), partnering with relevant IT functions.
• Responsible to approve product-related requirements across product(s) underlying the Capability
• Responsible for configuration, decision making and outcome, impacting the capability, with involvement of relevant Business Process Owner(s), business SMEs and stakeholders
• 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.

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Skills Desired
Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management