Manager, Program and Process Excellence

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

Job summary

Johnson & Johnson Innovative Medicine is recruiting a Manager, Program & Process Excellence based in Titusville, NJ or Horsham, PA. You will manage and optimize REMS program elements, coordinate cross-functional governance, and partner with risk leads to ensure compliant operations.

The role leads standardization, process improvements, and leverages technology to enhance efficiency and regulatory readiness across North America risk management programs.

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.
• Experience in project and vendor management, and strong regulatory knowledge.

Responsibilities

• Program Operations and cross-functional enablement for REMS initiatives.
• Coordinate governance, materials, decisions and follow-through across Core Team.
• Partner with Risk Management Leads, RMALs and stakeholders.
• Maintain program status visibility including KPIs and risk escalation.
• Support and lead REMS program development and operations as needed.
• Assist in budgeting, contracting and invoice approvals.

Skills

REMS management

Regulatory affairs

Pharmacovigilance

Medical affairs

Medical writing

Project management

Vendor management

Communication skills

Education

Bachelor's degree, life sciences preferred

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

  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 experienceStrong written and verbal communication skillsKnowledge and experience with FDA regulatory aspects of prescription drug development end-to-end.Experience with various types of US submissions including genericsFamiliar with risk management program operations, including call center, database development and management, and effectiveness assessmentFamiliar with regulatory aspects at various stages of development, from entry-into-man to post approval activitiesExperience 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:

    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

    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