What are the responsibilities and job description for the Manager, Case Processing position at Johnson & Johnson Innovative Medicine?
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
Pharmacovigilance
Job Category
People Leader
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description
We are searching for the best talent for our Manager, Case Processing position to be located in Horsham, PA; Raritan, NJ or Titusville, NJ.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United States - Requisition Number: R-068091
United Kingdom- Requisition Number: R-070284
Switzerland - Requisition Number: R-070281
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Purpose
The Manager, Case Processing directs and oversees the operational and people management activities of a team of Drug Safety Associates (DSAs) responsible for processing investigational Clinical Trial (CT) Individual Case Safety Reports (ICSRs), including activities required to meet Serious and Unexpected Suspected Adverse Reaction (SUSAR) reporting requirements (e.g., single case unblinding, analysis of similar events (AOSE)) at designated Case Processing Centers.
This role partners closely with Global Medical Safety Operations (GMSO) functions—including Global Case Management (GCM), Global Case Receipt, Global Safety Reporting, Medical Analytics & Safety Surveillance (MASS), and Pharmacovigilance Evaluation and Reporting (PVER)—as well as Clinical Development organizations and third‑party partners, to enable compliant, timely, and efficient end‑to‑end management of investigational CT ICSRs.
You Will Be Responsible For
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:
Cross-Functional Collaboration, Developing Others, Global Market, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operations Management, Performance Measurement, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Safety Investigations, Safety-Oriented, Safety Reporting, Serious Adverse Event Reporting, Team Management
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)).
Benefits
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
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
Pharmacovigilance
Job Category
People Leader
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description
We are searching for the best talent for our Manager, Case Processing position to be located in Horsham, PA; Raritan, NJ or Titusville, NJ.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United States - Requisition Number: R-068091
United Kingdom- Requisition Number: R-070284
Switzerland - Requisition Number: R-070281
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Purpose
The Manager, Case Processing directs and oversees the operational and people management activities of a team of Drug Safety Associates (DSAs) responsible for processing investigational Clinical Trial (CT) Individual Case Safety Reports (ICSRs), including activities required to meet Serious and Unexpected Suspected Adverse Reaction (SUSAR) reporting requirements (e.g., single case unblinding, analysis of similar events (AOSE)) at designated Case Processing Centers.
This role partners closely with Global Medical Safety Operations (GMSO) functions—including Global Case Management (GCM), Global Case Receipt, Global Safety Reporting, Medical Analytics & Safety Surveillance (MASS), and Pharmacovigilance Evaluation and Reporting (PVER)—as well as Clinical Development organizations and third‑party partners, to enable compliant, timely, and efficient end‑to‑end management of investigational CT ICSRs.
You Will Be Responsible For
- 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.
- 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.
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:
Cross-Functional Collaboration, Developing Others, Global Market, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operations Management, Performance Measurement, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Safety Investigations, Safety-Oriented, Safety Reporting, Serious Adverse Event Reporting, Team Management
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)).
Benefits
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
Salary : $117,000 - $201,250