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Manager, Case Processing, Global Medical Safety Operations (1 of 2)
Requisition ID: 9787170508
Janssen Research & Development, a part of the Johnson & Johnson family of companies, is recruiting for a Manager, Case Processing, Global Medical Safety Operations 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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Manager, Case Processing directs and supervises the operational and management activities of a team of Drug Safety Associates at a defined Case Processing Center. The Manager liaises with staff in Global Medical Safety Operations (GMSO) functions (Case Receipt, Sector Liaison, Global Regulatory Reporting) as appropriate to facilitate compliant, timely and efficient end-to-end case management.
- 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
- Directly responsible for the daily activities of a team of staff within Case Processing, Global Medical Safety Operations (GMSO)
- Manages teams/personnel in daily activities relating to case processing activities - overseeing performance management, staff development plans and execution of those plans.
- Participates in recruitment of staff
- Identifies resource needs and allocations to ensure appropriate functioning of team
- Evaluates and identifies staff training needs to ensure all personnel trained within team, and is responsible for oversight of training compliance of direct reports
- Expertise in operations activities including case processing (or other functional expertise)
- Contributes to development of processes and project deliverables as identified
- Collaborates with internal GMSO personnel to develop unified consistent processes
- Collaborates with other J&J departments to clarify procedures
- Participates in or leads local and international multidisciplinary functional teams
- Supports Director/Sr. Director in internal audits and external inspections
- Maintains compliance with company guidelines and HR policies
- 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).
- A minimum of 5 years relevant experience is required
- Previous industry and/or clinical experience with a focus on safety related areas, including individual and/or aggregate reports is required.
- Extensive knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations is required
- Experience in high volume work environment preferred
- Previous experience in a relevant leadership role is required
- Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance is required
- Ability to organize training activities and train personnel on safety topics
- Excellent verbal, written and presentation skills
- Familiarity with safety systems is required
- Knowledge or experience with Excel, PowerPoint, Visio preferred.
Janssen Research & Development, LLC. (6084)