Manager, Program and Process Excellence
Johnson & Johnson Innovative Medicine
Summary
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.
Job description
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
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 and improve SOPs, Work Instructions, checklists, and electronic workflows
Quality, Compliance, and Readiness
- Maintain inspection-ready documentation and program records
- Manage or coordinate CAPAs, Quality Issues, and remediation activities, as needed
- Support audit and inspection readiness through document retrieval, response development, storyboarding, and implementation tracking
Requirements
- Bachelor’s Degree, life sciences preferred
- At least 5 years of experience, of which 3 years in REMS, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Medical Writing, or similar; equivalent combination of advanced degree and less experience will be considered
- Project management and vendor management experience
- Strong written and verbal communication skills
- Knowledge and experience with FDA regulatory aspects of prescription drug development end-to-end
- Experience with various types of US submissions including generics
- Familiar with risk management program operations, including call center, database development and management, and effectiveness assessment
- Familiar with regulatory aspects at various stages of development, from entry-into-man to post approval activities
- Experience or familiarity with clinical trial operations, pharmacovigilance operations, and/or New Drug Applications (NDAs) or Biologics License Applications (BLAs)
- Ability to influence within function, cross-functionally and globally
- Ability to travel domestically occasionally and internationally, up to 25%
Benefits
- Pension Plan
- 401(k) Savings Plan
- Long-Term Incentive Program
- Vacation
- Sick Time
- Holiday Pay
- Floating Holidays
- Parental Leave
- Bereavement Leave
- Caregiver Leave
- Volunteer Leave
- Military Spouse Time-Off
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.