Johnson & Johnson Careers

Associate Director, Investigational Clinical Trial Case Processing

Horsham, Pennsylvania
Drug & Product Safety Operations


Job Description

Requisition ID: 9813190716

Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director Investigational Clinical Trial Case Processing located in Horsham, PA.


The Associae Director Investigational Clinical Trial Case Processing provides strategic oversight and management for case processing activities associated with investigational clinical trials (CT).  Directs and supervises Managers responsible for the operational and management activities of a team of Drug Safety Associates (DSAs) dedicated to processing investigational CT Individual Case Safety Reports (ICSRs) at defined Case Processing Centers.  Liaises with staff in Global Medical Safety Operations (GMSO) functions, Global Case Management (GCM) Case Receipt, Safety Reporting, Medical Safety Surveillance & Insight (MSSI) and PV Sciences (PVER) as appropriate to facilitate compliant, timely and efficient end-to-end case management of investigational CT ICSRs.  Partners with stakeholders from key Clinical Development Organizations, including third party partners conducting clinical trial activities on behalf of Clinical, to ensure accurate and timely submission of CT ICSRs. 


The Associate Director Investigational Clinical Trial Case Processing will:

  • Liaise with Janssen Clinical Development Organizations (e.g. Global Clinical Organization (GCO), Medical Affairs, Infectious Diseases and Vaccines Clinical Early Development group, etc.) and Clinical Preferred Providers performing clinical trial activities related to safety case management
  • Manage review of Clinical Trial Protocols and Safety Management Plans (SMP)
  • Ensure accuracy of safety database study configuration and confirmation of test article identification in alignment with the study protocol, SMP and Trial Master Source (TMS)
  • Review and action TMS documents to approve Global Medical Safety (GMS) related activities
  • Interface with Global Clinical Organization Safety Unit (GCO-SU) responsible for Investigator Letter distribution to required recipients, including Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs)
  • Liaise with Integrated Data Services (IDS) regarding Serious Adverse Event (SAE) Reconciliation, Single Case and End of Study Unblinding activities
  • Liaise with Global Regulatory Affairs (GRA) to confirm Marketing Authorization Holder approval numbers and reporting obligations
  • Contribute to the review of Clinical Trial Agreements (CTA), Pharmacovigilance Agreements (PVA), Collaboration Agreements (CA), and determining required procedures and implementation of safety reporting rules to ensure safety data exchange within defined timelines
  • Lead Pharmacovigilance Operational Team meetings (PVOT)
  • Participate in Safety Management Team meetings addressing Case Management action items
  • Ensure accuracy and accessibility of product information (e.g. product approval numbers, protocol information, product specific case processing information/guidance, product responsibility contact references, etc.) required to meet case management and AE reporting obligations
  • Directly responsible for the management of Case Processing Managers
  • Provides strategic leadership to Managers and staff within Case Processing, GMSOPerforms performance management activities including staff development plans and execution of those plans for direct reports and provides oversight related to team performance and development activities
  • Participates in recruitment of staff
  • Identifies resource needs and allocates resources to ensure appropriate functioning of team
  • Contributes to development and implementation of strategic direction for case processing function
  • Supports and deputizes for Global Director Case Processing as identified
  • Contributes to development of processes and project deliverables as identified
  • Collaborates with internal GMS personnel to develop harmonized consistent processes
  • Collaborates with other J&J departments (e.g. GCO, Medical Affairs, Contract Research Organization (CROs), GRA, etc.) to resolve questions regarding safety related procedures
  • Participates in or leads multidisciplinary functional teams, in-person, virtual and across various time zones
  • Supports Director/Sr. Director in internal audits and external inspections


Qualifications
Qualifications:
  • RN or BS degree in health-related field, PhD/PharmD or other related scientific degree/qualification
  • 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 required. Typically demonstrated by a minimum of 8 years pharma experience and 3 years in a management role
  • Extensive knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting regulations through-out product life cycle (investigational and post-marketing) required
  • Experience with multinational integration activities
  • Experience in high volume work environment preferred
  • Previous experience in a relevant management role is required
  • 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
  • Ability to thrive in a global matrix environment
  • 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-
Organization
Janssen Research & Development, LLC (6084)
Job Function
Drug & Product Safety Operations
Requisition ID
9813190716