Manager, Program and Process Excellence

Johnson & Johnson

. Manage and enable development, implementation, monitoring, and assessment of North America risk management programs, including REMS .

Posted 10/26/2026full-timeUnited StatesMid-LevelSenior💰 $117,000 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing and executing REMS programs, including regulatory submissions and compliance documentation. Proficient in project management, vendor management, and cross-functional collaboration to enhance risk management operations.

Highest-signal resume keywords

REMS Program ManagementRegulatory Affairs ExperienceProject Management SkillsFDA Regulatory KnowledgeCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk Management Program OperationsClinical Trial OperationsPharmacovigilance OperationsUS Submissions ExperienceDocumentation ManagementKPI MonitoringCAPA ManagementQuality Issue ManagementAutomation ImplementationEffectiveness Assessment

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationInfluencing Skills

Tools & Technologies

Database DevelopmentElectronic WorkflowsSOP Management

Industry Keywords

Life SciencesFDA ComplianceMedical AffairsMedical WritingRisk Evaluation and Mitigation Strategies

About the role

Key responsibilities & impact

Manage and enable development, implementation, monitoring, and assessment of North America risk management programs, including REMS
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 Risk Management Leads, Risk Management Area Leads, and cross-functional stakeholders
Maintain program status visibility, including KPIs, and escalate risks/issues appropriately
Support and/or lead Shared System REMS program development and operations
Support business planning, contracting, budgeting, and invoice approvals
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
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
Support audit and inspection readiness through document retrieval, response development, storyboarding, and implementation tracking
Partner with Risk Management Leads and report to the Director, US Risk Management Operations

Requirements

What you’ll need

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 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
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-market 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
Ability to travel domestically occasionally and internationally, up to 25%

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year