Johnson & Johnson Careers
Signal Tracking Coordinator (Manager-level)
Horsham, Pennsylvania; Raritan, New Jersey; Titusville, New Jersey
Drug & Product Safety Science
Requisition ID: 6367181104
Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Signal Tracking Coordinator (Manager-level). This position may be based in Horsham, PA, Raritan, NJ, or Titusville, NJ.
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.
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 Signal Tracking Coordinator (Manager-level) is responsible for management of all aspects of the Signal Tracking System including data entry and maintenance, system administration, and ensuring consistency and inspection readiness in the Global Medical Organization (GMO). You will provide oversight for all aspects of the Signal Tracker System (STS) process. Perform entry of Topics and Topic Updates in Empirica Topics (Oracle) for Pharma, Omrix, and vaccine products. Review and quality check (QC) of all Topics entered in Empirica Topics to ensure data quality and consistency. Manage process for Topic entry and signal management in the STS, including the development of job aids, training, and updates to standard operating procedures. Lead system and process improvements of the STS in Empirica Topics. Provide daily updates to the STS SharePoint. Provide STS data per ad hoc request from GMO. Run metrics for MSA/SMG group and managing compliance. Perform user administration and troubleshooting system or process issues.
Signal Tracking System data entry and QC:
• Receipt of new and follow up STS entry forms from GMS personnel responsible for signal management
• Review and QC of the STS form contents
• Coordination of clarifications/corrections of STS form content with the owner, if the data is not in compliance with quality or medical standards.
• Accurate entry of new or updated Topics to the Signal Tracking System within timelines
STS Process and System development/Maintenance:
• Manage process for Topic entry and signal management in the STS, including the development of job aids, and updates to standard operating procedures
• Participate in system and process improvements of the STS in Empirica Topics
• Implement process improvements which result in efficiencies and reduction of compliance risk
• Participate strategic discussions for changes needed in STS resulting from regulatory changes
• Perform data cleaning activities as needed
• Training on STS process, tools, and concepts
• Responding to questions on STS or signal management process
• Ongoing monitoring and periodic metrics of compliance to STS timelines
• Data management: daily downloads and ad hoc request
• SME for Signal Tracking system
• Trouble shoot technical issues and user administration with the system and coordinate with Oracle as needed
• Support projects and regulation review using STS data to meet regulatory requirements
• Changes required in the STS to best fit business need and regulatory requirements
• Identifying areas and process improvements in the STS or Management process
• A minimum of a BA or BS degree in a life sciences or technology discipline (Graduate degree, preferred) with a minimum of 3 years of industry experience, preferably in a clinical or pharmacovigilance role
• 1-3 years of project management experience highly preferred
• Clinical medical experience highly preferred.
• Expert in manipulation of data in Excel is required, and good knowledge of other Microsoft Office tools
• Experience in use of analytics system and data retrieval is preferred.
• Experience in maintaining and administering Empirica Topics strongly preferred.
• Experience in tier 1 end-user support and issue escalation, eliciting and communicating user requirements, and software change control is preferred.
• VBA proficiency is preferred.
• Meticulous attention to detail and ability to identify issues and drive for resolution is preferred
• Ability to influence and manage change
• Analytical thinker/problem solver
• Basic understanding of industry regulations and compliance needs is preferred
• Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational & business issues.
• Must be strong independent worker and team player
• Excellent verbal and written communication skills, including formal presentation skills are required.
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Drug & Product Safety Science