Johnson & Johnson Careers
SR MANAGER LOGISTICS TRIAGE AND SUBMIS
Requisition ID: 4679190118
Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Senior Manager of Logistic, Triage and Submission located in Cherry Hill, NJ or South San Francisco, CA
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Senior Manager of Logistic, Triage and Submission ensures the effective implementation and coordination of all US initial adverse event case processing intake including management of Drug Safety correspondence, pre-case assessment, case book-in, and assigned AE case workflow activities through the Global Drug Safety Department in compliance with applicable FDA and global regulations and Actelion Standard Operating Procedures (SOPs) and guidelines. He/she is responsible for dedicated case processing and continuous quality assurance improvement activities, and ensures process harmonization / consistency across all global data entry sites.
The Senior Manager of Logistic, Triage and Submission will:
- Oversee US Drug Safety Coordinators and Drug Safety Case Managers responsible for the initial intake and assessment of adverse event information received by the US Drug Safety Department across both US sites, and ensures the maintenance of the workflow process
- Handles and maintains all US Drug Safety correspondences from all sources.
- Supervises the initial receipt, book in, initial report assessment, initial data entry, and document preparation for sponsored trials and post-marketing sources
- Insures the communication for requesting follow up from reporters in order to obtain complete AE information
- Leads consistent documentation of report reconciliation and acknowledgments to Specialty Pharmacies, Corporate Partners and other reporters
- Responsible for collaboration with the Drug Safety Operations Case Processing Senior Managers for maintaining the workflow and balancing the workload globally.
- Assists with other ad hoc safety projects as requested by Global Head of Drug Safety Operations
- Responsible for coordinating and ensuring the maintenance and storing of all electronic Adverse event source documents in designated document management systems.
- Acts as the main support for the production and delivery of source documents and as subject matter expert for Drug Safety coordinators and DSCMs responsible for the initial assessment and processing activities during internal, business partners and Health Authority audits..
- Identifies and promptly communicates deviations from workflow and standard operating procedures and work practices, investigates root causes, and recommends appropriate corrective and preventative actions
- Initiates corrective action items and preventative action plans to address quality issues, in cooperation with the DS Systems Compliance and Training group.
- Leads the creation and compliance of Actelion policies and department standard operating procedures pertaining to drug safety initial intake workflow activities
- Maintains, in coordination with DS leadership, the use of the work-in-progress line listings, metrics, and/or other case management prioritization tools
- Leads as Subject Matter Expert to identify training needs to address quality, case assessment, workflow, and timelines issues related to the reporting of adverse events received from Specialty Pharmacies, business partners, and other reporters
- Ensures compliance with reconciliation activities in collaboration with the Head of Compliance and Training
- Actively supports clinical project team case manager activities to ensure the implementation of all safety activities associated with clinical trials
- Responsible for the leadership, management, coaching and mentoring of all US Drug Safety Coordinators and Drug Safety Case Managers responsible for the initial report assessment, ensuring consistency and quality across all global data entry sites. This person is responsible for assessing performance review and personnel development of direct reports
- BS in Pharmacy, Nursing or related health field required. A minimum of 8 years relevant experience of which 6 years are in biopharmaceutical industry and five years are experience in drug safety data management and case processing or equivalent combination of advanced degree and relevant experience
- 2 years management experience required
- Clinical experience and experience with preparation of investigational and post-marketing regulatory reports required
- Knowledge of relevant FDA, EU, ICH, Pharmacovigilance guidelines, initiatives and regulations required
- Excellent oral and written communication skills including the ability to persuade and influence opinions
- Knowledge of medical terminology and familiar with disease process
- Ability to think strategically, able to think out of the box pragmatically and produce innovative changes
- Computer proficiency (Word, Access, and Excel); knowledge of safety databases or the ability to learn new systems
- Highly organized, detail oriented, and understanding of workflow prioritization.
- Able to work under pressure and meet tight timelines
- General knowledge of coding thesauri and drug dictionaries.
- Proficiency in technical safety systems including Argus
- Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with regulations
- Stimulate initiative, problem solving, pro-active continuous improvement attitude
- This position requires travel up to 50% of the time
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Cherry Hill-
North America-United States-California-South San Francisco
Janssen Research & Development, LLC. (6084)