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CASE PROCESSING MANAGER

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Job Description


Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Case Processing Manager located in Horsham, Raritan NJ or High Wycombe, England.


In this position you will direct and supervises the operational and management activities of a team of Drug Safety Associates (DSAs) dedicated to processing ICSRs and performing vendor oversight functions at a defined Case Processing Center. Liaises with staff in Global Medical Safety Operations (GMSO) functions, Global Case Management (GCM) Case Receipt, Sector Liaison, Global Regulatory Reporting, as appropriate to facilitate compliant, timely and efficient end-to-end case management.


The Case Processing Manager will:
  • Responsible for workload management, ensuring ICSR quality standards and compliance timelines are met
  • Subject matter mentorship, product/process expertise and leadership to Vendor Personnel
  • Monitor defined Quality Control procedures (e.g. quality check line listings, oversight activities, etc.) to ensure timely completion and resolution of discrepancies
  • Special project leadership, planning, implementation and post project review
  • Provide strategic resource planning with counterparts to lead intermittent bolus activities and identify resource needs above defined sourcing levels to identify alternate options (e.g. supplemental sourcing strategies)
  • Assign resources to ensure appropriate functioning of team
  • Contribute to development and implementation of strategic direction for case processing functions
  • Lead Pharmacovigilance Operational Team (PVOT) meetings with business partners
  • Support internal audits and external inspections
  • Perform performance management activities, including establishment and monitoring progress of team member goals and objectives, staff development plans, and execution of those plans for direct reports
  • Participate in recruitment of staff 


Qualifications
Qualifications:
  • RN or BS degree in health-related field, PhD/PharmD or other related scientific degree/qualification required OR for nurses and pharmacists, certification/licensure is required (e.g. RN, RPh,PharmD)
  • Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports. Typically demonstrated by a minimum of 5 years pharma experience preferred
  • Extensive knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations preferred
  • Experience in high volume work environment preferred
  • Ability to allocate resources and provide personnel management to staff
  • Ability to identify, hire and retain professional staff
  • Previous experience in a relevant management role is preferred, however is not essential
  • Strong leadership skills, ability to lead a team
  • Leadership skills for planning professional development of direct reports
  • Ability to coordinate and harmonize workflow activities of the team
  • Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance
  • Ability to utilize appropriate initiative and autonomy in achieving objectives; works independently
  • Ability to facilitate change
  • Demonstrates strong Credo values
  • Ability to organize training activities and train personnel on pharma safety topics
  • Ability to identify training needs of team members
  • Excellent verbal, written and presentation skills
  • Good computer skills (Word, email) and familiarity with safety systems
  • Knowledge or experience with Excel, PowerPoint, Visio preferred
 

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

 


Primary Location
United States-Pennsylvania-Horsham-100 Tournament Drive
Other Locations
North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
Pharmacovigilance
Requisition ID
4661190912