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 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
Qualifications- 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
Other requirements- Ability to travel domestically occasionally and internationally, up to 25%
Required Skills:Preferred Skills:Business Alignment, Clinical Operations, Coaching, Compliance Management, Compliance Risk, Critical Thinking, Data Reporting, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Researching, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing
The anticipated base pay range for this position is :$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
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 the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
