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Associate Director, Case Processing
Drug & Product Safety Operations
Requisition ID: 7040171214
Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Case Processing located in Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Director, Case Processing directs and supervises the operational and management activities of a team of Drug Safety Associates (DSAs) dedicated to processing investigational CT Individual Case Safety Reports (ICSRs), including activities required to meet Serious Unexpected Suspected Adverse Reaction (SUSAR) reporting (requesting single case unblinding, preparation of analysis of similar events (AOSE), etc.) 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 clinical trial ICSRs.
Scope of responsibilities include:
- 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, 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
- 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
- Provides strategic leadership to Managers and staff within Case Processing, GMSO.
- Performs 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.
- Identifies resource needs and allocates resources to ensure appropriate functioning of team.
- Contributes to development and implementation of strategic direction for case processing functions
- 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.
- Maintains compliance with company guidelines and HR policies
- Is accountable for decision-making relating to processes and product-specific requirements relevant to assigned team/therapeutic area
- Serves as an influential change agent within GMSO when changes are implemented
- BS degree in health-related field is required; Licensed RN, PhD/PharmD or other related scientific degree is preferred
- A minimum of 8 years of industry and/or clinical experience with a focus on pharmaceutical safety related areas is required
- A minimum of 3 years in a management role is required
- Individual and aggregate reports experience is preferred
- 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) is preferred
- Experience with multinational integration activities is preferred
- Proven experience evaluating processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance is required
- Experience organizing training activities and train personnel on pharma safety topics is preferred
- Strong experience using MS Office and familiarity with safety systems required
- This position will be located in Horsham, PA and requires less than 10% travel
Janssen Research & Development, LLC. (6084)
Drug & Product Safety Operations