Manager, Case Processing
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Horsham • New Jersey • Pennsylvania • United States
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Salary
💰 $117,000 - $201,250 per year
About the role
- Directly leading the daily operational activities of a Global Case Processing team within Global Medical Safety Operations, ensuring effective workload management and adherence to ICSR quality and timeline standards.
- Managing and supporting team members in day‑to‑day case processing activities through coaching, guidance, performance management, and ongoing staff development.
- Ensuring the quality, accuracy, and regulatory compliance of team‑processed ICSRs, with particular focus on SUSAR reporting requirements, including completeness of case narratives, coding activities, AOSE, and related documentation.
- Overseeing defined quality control and oversight procedures to ensure timely completion, issue identification, and resolution of discrepancies.
- Performing people‑management responsibilities, including goal setting, performance evaluations, development planning, participation in recruitment, identification of training needs, and oversight of training compliance for direct reports.
- Leading resource planning and allocation activities to support routine operations and evolving clinical program needs, ensuring appropriate staffing to maintain operational continuity and compliance.
- Monitoring clinical program activities and trends that may impact case management operations and proactively adjusting resources and plans as needed.
- Providing strategic resource planning in partnership with cross‑functional counterparts to manage intermittent or surge activities (e.g., SAE reconciliation, interim and end‑of‑study unblinding), including escalation of resourcing needs beyond defined sourcing models and identification of alternate solutions.
- Serving as a subject‑matter expert in clinical trial case processing and contributing to the development and execution of strategic objectives for Global Case Processing.
- Partnering with MASS and Medical Safety Officers (MSOs) to address GCO ICSR‑related inquiries; participating in Safety Management Team (SMT) and Pharmacovigilance Operational Team (PVOT) meetings; and ensuring team awareness of case processing obligations and timelines associated with Clinical Trial Agreements (CTAs), Pharmacovigilance Agreements (PVAs), and Collaboration Agreements (CAs).
- Supporting and deputizing for the Associate Director or Director, Global Case Processing, as required, including participation in internal audits, external regulatory inspections, and other leadership initiatives.
- Maintaining compliance with company guidelines, pharmacovigilance regulations, and HR policies, and performing other related duties as assigned.
Requirements
- Bachelor’s degree in a health‑related or scientific discipline (e.g., Nursing, Pharmacy, Life Sciences) is required.
- An advanced degree (PhD, PharmD) is preferred.
- For nurses or pharmacists, active professional licensure/certification (e.g., RN, RPh, PharmD) is required.
- Minimum of 5 years of pharmaceutical industry or clinical experience with a focus on pharmacovigilance and drug safety, including individual and aggregate safety reporting is required.
- Demonstrated knowledge of global safety reporting regulations and regulatory compliance across the product lifecycle (investigational and post‑marketing environments).
- Experience working in a high‑volume, regulated operational environment preferred.
- Demonstrated people‑management capability, including resource allocation, performance management, hiring, onboarding, staff development, and training within a regulated pharmaceutical setting.
- Ability to plan, coordinate, and harmonize team workflows to meet quality, compliance, and timeline expectations.
- Experience evaluating processes and implementing improvements to enhance efficiency, accuracy, and compliance.
- Strong leadership skills with the ability to motivate teams, manage change, and operate with appropriate autonomy and initiative.
- Demonstrated commitment to Credo‑based values and ethical decision‑making.
- Knowledge of the legislative and regulatory context governing pharmacovigilance activities.
- Excellent verbal, written, and presentation skills with the ability to communicate effectively across functions and levels.
- Proficiency with standard office applications (Word, email); familiarity with pharmacovigilance safety systems required.
- Working knowledge of Excel, PowerPoint, and process‑mapping tools (e.g., Visio) preferred.
Benefits
- 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)).
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancedrug safetysafety reportingICSR processingSUSAR reportingregulatory complianceperformance managementresource allocationprocess evaluationworkflow coordination
Soft Skills
leadershipteam motivationchange managementcommunicationcoachingstaff developmentproblem-solvingautonomyinitiativeethical decision-making
Certifications
RNRPhPharmD