Senior Analyst, Standards Specialist

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Quality

Quality Documentation

Professional

Georgia (Any City), Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Toronto, Ontario, Canada

Johnson & Johnson is currently seeking a Senior Analyst, Standards Specialist, to join our Enterprise Regulatory Intelligence function within J&J’s Enterprise Regulatory Compliance organization.

The Standards Specialist, Senior Analyst, supports the enterprise quality standards program by coordinating and facilitating timely updates to enterprise quality standards and related tools. This role manages the day-to-day execution of the standards revision process by partnering with sector subject matter experts (SMEs) to incorporate approved changes, routing documents through the document management system for review and approval, and ensuring that updates are implemented according to the agreed-upon schedule.

The Senior Analyst also maintains program metrics and supports ongoing access to standards content through internal systems and the standards website.

• Coordinate end-to-end revisions of enterprise quality standards, including intake and tracking of change requests, review of change assessments for completeness and clarity, and preparation of revision packages for governance review.
• Partner with sector SMEs and standards owners to facilitate content and revision updates.
• Route standards and related documents through the document management system for review and approval, ensuring that documents are published in accordance with applicable procedures.
• Maintain the periodic review calendar and support scheduled reviews to ensure standards are reviewed and updated according to the defined program commitments.
• Maintain and report program metrics (e.g., number of revisions, cycle time, on-time completion, backlog), identifying trends and opportunities to improve the efficiency and predictability of the standards program.
• Facilitate updates to internal regulatory standards tools by documenting the regulations or guidance that drove specific standard updates and ensuring that related references and sections are updated and traceable.
• Partner with Regulatory Intelligence managers to conduct periodic environmental scans that inform the continuous improvement of enterprise standards.
• Ensure access to standards by coordinating updates to the internal standards website so that stakeholders can easily locate current standards and supporting resources.
• Actively build AI literacy and fluency and apply approved AI tools to streamline standards program workflows (e.g., change-request triage, drafting and editing support, and publishing coordination) while adhering to appropriate governance, privacy, and compliance requirements.
• Help to shape, and…