Janssen Research & Development, a part of the Johnson & Johnson family of companies, is recruiting for a Manager, Case Processing to be 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager, Case Processing will direct and supervise the operational and management activities of a team of Drug Safety Associates at a defined Case Processing Center. This Manager will also liaise with staff in the 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. This person will be directly responsible for the daily activities of a team of staff within Case Processing, GMSO.
- Manages teams/ personnel in daily activities relating to case processing activities, i.e. 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 and consistent processes
- Participates in or leads local and international, multidisciplinary functional teams
- Supports Director/Senior Director in internal audits and external inspections
- Maintains compliance with company guidelines and HR policies
- Will be accountable for decision-making related to processes and product-specific requirements relevant to assigned team/therapeutic area
- Serve as an influential change agent within GMSO when changes are implemented
- Knowledge or experience with MS Office (Excel, Word, PowerPoint) and Visio preferred
- Directly responsible for the daily team activities; strategic oversight of workload, productivity, and ensuring effective resource management to maintain regulatory compliance and quality standards.
- Provide mentoring and supervision of case processing personnel.
- Demonstrate expertise in operational activities
- Evaluate and identify staff training needs including oversight of training compliance
- Continual assessment of processes to ensure alignment with global regulations
- Author controlled documents
- Demonstrate expertise in operational activities
- Liaise with case processing vendors, providing oversight of assigned product portfolio.
- Collaborate with business partners ensuring operational excellence as related to PV agreements and ICSR exchange compliance.
- Lead special projects including process improvement and CAPA activities
- Supports Director/Sr. Director in internal audits and external inspections as a key representative.
- Lead change management initiatives
- Role model behaviors that support the Credo
- An RN or BS degree in a health-related field is required. A PhD/PharmD or other advanced degrees in a related scientific degree/qualification is preferred.
- For nurses and pharmacists, certification/licensure is required (e.g. RN, RPh, PharmD)
- A minimum of 8 years of previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports is required
- A minimum of 5 years’ experience in a relevant management role, with a strong ability to allocate resources and provide personnel management of staff is required
- Extensive knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations is required
- Prior experience in a high-volume work environment is preferred
- Ability to identify, hire and retain professional staff, strong leadership skills is required
- Demonstrated skills to lead a team, plan professional development, and facilitate change for direct reports is required
- Experience coordinating and harmonizing workflow activities of the team is required
- Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance is required
- Ability to identify training needs of team members, and organize training activities to train personnel on pharmaceutical safety topics is preferred
- Previous familiarity with safety systems is required
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.
Janssen Research & Development, LLC. (6084)