Manager, Program and Process Excellence

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Job Function:
Product Safety

Job Sub Function:
Product Safety Risk Management

Job Category:
Scientific/Technology

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson&Johnson Innovative Medicine is recruiting for a Manager, Program & Process Excellence to be based in Titusville, NJ or Horsham, PA.

The Manager, Program & Process Excellence manages and enables the development, implementation, monitoring, and assessment of North America risk management programs, including Risk Evaluation and Mitigation Strategies (REMS).

This position partners with Risk Management Leads, and reports to the Director, US Risk Management Operations.

Day-to-day responsibilities:

Program Operations and Cross-Functional Enablement


* Manage, support, and enable operational execution of REMS program elements and modifications


* Coordinate and facilitate vendor and/or cross-functional Core Team governance, materials, decisions, and follow-through


* Serve as an operational partner to RMLs, RMALs, and cross-functional stakeholders


* Maintain program status visibility, including Key Performance Indicators (KPIs), and escalate risks/issues appropriately


* Support and/or lead Shared System REMS program development and operations as needed


* Support business planning, contracting, budgeting, and invoice approvals

Risk Management Reporting Compliance and Regulatory Support


* Lead, coordinate and/or contribute to REMS modifications, revisions, regulatory submissions, and FDA responses


* Manage timelines, documentation, inputs, and stakeholder reviews for REMS Assessment Reports


* Maintain compliant risk management program/REMS documentation, with the Risk Management Lead(s)


* Partner with vendors and cross-functional teams on effectiveness assessment activities

Process Excellence and Continuous Improvement


* Drive standardization and process improvements across Risk Management Programs


* Identify and implement technology, automation, and AI-enabled opportunities to improve efficiency and compliance


* Maintain...