Manager, Program and Process Excellence
About The Position
Johnson & Johnson Innovative Medicine is recruiting a Manager, Program & Process Excellence, based in Titusville, New Jersey, or Horsham, Pennsylvania. The role manages and enables the development, implementation, monitoring, and assessment of North America risk management programs, including Risk Evaluation and Mitigation Strategies (REMS). It partners with Risk Management Leads and reports to the Director, US Risk Management Operations. The position supports REMS program operations and modifications, coordinates vendor and cross-functional governance, and works with Risk Management Leads, Risk Management Alliance Leads, and other stakeholders. It maintains program status visibility, including KPIs, and supports Shared System REMS, business planning, contracting, budgeting, and invoice approvals. The role coordinates REMS modifications, regulatory submissions, FDA responses, and REMS Assessment Reports. It maintains compliant program documentation and partners with vendors and cross-functional teams on effectiveness assessments. It also drives process standardization and improvement, including technology, automation, and AI-enabled opportunities, and maintains SOPs, Work Instructions, checklists, and electronic workflows. The Manager maintains inspection-ready documentation and records; coordinates CAPAs, Quality Issues, and remediation activities as needed; and supports audit and inspection readiness. Occasional domestic and international travel, up to 25%, is required.
Requirements
- Bachelor’s degree; life sciences preferred.
- At least 5 years of experience, including 3 years in REMS, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Medical Writing, or a similar area; an equivalent combination of an 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.
- Familiarity with risk management program operations, including call center, database development and management, and effectiveness assessment.
- Familiarity 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 or Biologics License Applications.
- Ability to influence within the function, cross-functionally, and globally.
- Ability to travel domestically occasionally and internationally, up to 25%.
Nice To Haves
- Life sciences degree.
- Familiarity with clinical trial operations, pharmacovigilance operations, and/or New Drug Applications or Biologics License Applications.
Responsibilities
- Manage, support, and enable operational execution of REMS program elements and modifications.
- Coordinate and facilitate vendor and cross-functional Core Team governance, materials, decisions, and follow-through.
- Serve as an operational partner to Risk Management Leads, Risk Management Alliance Leads, and cross-functional stakeholders.
- Maintain program status visibility, including Key Performance Indicators, and escalate risks and issues appropriately.
- Support or lead Shared System REMS program development and operations as needed.
- Support business planning, contracting, budgeting, and invoice approvals.
- Lead, coordinate, 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 and REMS documentation with the Risk Management Leads.
- Partner with vendors and cross-functional teams on effectiveness assessment activities.
- 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.
- 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.
- Travel domestically occasionally and internationally, up to 25%.
Benefits
- Eligibility to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
- Eligibility to participate in the Company’s long-term incentive program.
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
- Holiday pay, including Floating Holidays: 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.
- Parental Leave: 480 hours within one year of a child’s birth, adoption, or foster care placement.
- Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver Leave: 80 hours in a 52-week rolling period.
- Volunteer Leave: 32 hours per calendar year.
- Military Spouse Time-Off: 80 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
