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Director, Proactive Risk Intelligence & Safety Management (PRISM) Program Lead
Johnson & Johnson
Raritan, NJ, United States
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Janssen Research & Development, LLC, a Johnson & Johnson Company, is currently recruiting for Director, Proactive Risk Intelligence & Safety Management (PRISM) Program Lead to be located in Raritan or Titusville, NJ. This position is project based and time bound to the project timeline (estimated 24 months from date of hire).
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.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. 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 Director, Proactive Risk Intelligence & Safety Management (PRISM) Program Lead is responsible for supporting and oversight of the Business Project Team for the PRISM (Proactive Risk Intelligence & Safety Management) platform. Ensure the team meets worldwide aggregate reporting requirements and single case efficiencies. Lead a team which will deliver a data warehouse: foundation for aggregate reporting, data analytics & query capability to enable data access and self-service reporting and a single case system evaluation & replacement system. Incumbent will partner with the Global Medical Organization and other business stakeholders to ensure PRISM activities are fulfilled with data integrity according to defined requirements and timelines.
Principal Responsibilities:
• Oversee the project timelines and business resource scheduling / management for PRISM to ensure Business Representatives are available to participate in meetings, UAT, requirements gathering and other activities to deliver the PRISM platform. Establish and lead aligned governance, processes and expectations for PRISM. Ensures PRISM is fully compliant and inspection ready.
• Interfaces with global business SMEs and manage ongoing PRISM activities to ensure successful systems deployment. Works across functional lines to ensure system deployment. Provides strategic direction and tactical management of PRISM.
• Partners with GMSO SMEs, IT, Consumer and Procurement to define or gather business requirements, define new business and support processes which improve existing processes. Liaise to provide / review impact assessments related to business requirements or processes that cannot be fully achieved and determine alternative means to mitigate impact.
• Establishes and executes a cohesive and integrated strategy for PRISM and systems that will integrate with PRISM
Qualifications
• Bachelors degree or 25 years of industry experience is required
• Minimum 12 years of pharmacovigilance and 10 years of IT experience is required
• Global Experience: Interaction/Understanding of Drug Safety and global working environment is required
• Drug Safety Experience is required
• Aggregate report writing experience and competence is preferred
• Global Safety-Regulatory knowledge; familiarity with resources is preferred
• Experience managing off-shore service providers is preferred
• Up to 20% both domestic and international travel is required