Manager, Program and Process Excellence

Johnson & Johnson Co.; Titusville (NJ); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson Innovative Medicine seeks a Manager, Program & Process Excellence to lead REMS program development and operational execution from Titusville, NJ or Horsham, PA. You will partner with Risk Management Leads and cross-functional teams to enable REMS processes, regulatory filings, and continuous improvement.

The role requires deep REMS/regulatory knowledge, strong project and vendor management, and a focus on compliance and process optimization within a global health environment.

Qualifications

• Bachelor’s Degree, life sciences preferred.
• At least 5 years of experience, with 3 years in REMS, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Medical Writing, or similar; advanced degree with less experience 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 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 NDAs or BLAs.
• Ability to influence within function, cross-functionally and globally.

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 KPIs, and elevate risks/issues.
• 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.

Skills

Project management

Vendor management

Regulatory knowledge

Cross-functional collaboration

Strong communication

Education

Bachelor’s Degree, life sciences preferred

Advanced degree (preferred)

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 elevate 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%

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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

• 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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.