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Connected Health Solutions Expert
Requisition ID: 1805634803W
‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Connected Health Solutions & Operations (CHS&O) Expert supports the technology ‘solutions’ within the CHS&O group. CHS&O ensures various technologies used within clinical studies are study-specific, validated and compliant. Technologies may include e-Informed Consent, eMeds, and Apps for ePRO collection. The incumbent will be required to be knowledgeable in system development, user acceptance testing and subject matter expertise. The incumbent may lead, with minimal supervision, system development activities and be the point of contact for cross-functional study teams. The incumbent is expected to maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure Connected Health Solutions & Operations (CHS&O) processes are at the ‘best practice’ level of performance. This position will be based in Beerse, Belgium or Malvern, PA.
- Provide advice/recommendation to study teams regarding the supplier(s) and device/technology alternatives
- Provide leadership related to supplier specification development, set-up & system execution
- Provide technical direction to the cross-functional study team through changes of scope providing expertise/scope change, assessment of risk, oversight of system requirements updates and user acceptance testing as necessary
- Assist in the resolution of issues escalated by study teams with minimal supervision by CHS&O line manager
- Assist with inspection readiness activities as needed
- Monitor key performance indicators (KPIs) for services provided by suppliers
- Conduct Lessons Learned sessions following the completion of start-up activities, and, as necessary, throughout other phases of the clinical development process
- Effectively support the study team in close-out/deactivation of systems
- Continually review new emerging technologies focusing on efficiencies to be gained
- Ensure that principles of Credo and Business Conduct Policy, Purchasing Code of Conduct, Healthcare Compliance and Ethical Code of Conduct of Pharmaceutical Medicine are used in supplier relationships
- Bachelor’s degree (University degree) or equivalent required; advanced degree preferred
- At least 3 years working with technologies in a pharmaceutical company and/or a Clinical Research Organization is required
- Ability to prioritize, project manage & multi-task necessary
- Change management and Issue escalation experience highly desired
- Good understanding of the therapeutic areas where Janssen is involved (CNS, CV/Met, Immunology, Infectious Disease, Oncology) is preferred
- Expertise working w/Apps, e-Informed Consent technologies preferred
- Familiarity with data management systems (e.g. RAVE) & IT SDLC process experience preferred
- Strong analytical skills with a proven ability to uncover underlying facts & complex relations in data is required
- Strong listening, oral and written communication skills required
- The ability to facilitate interactive sessions with the business and functional personnel required
- Ability to track, monitor and communicate relevant issues and risks and suggest alternative approaches/recommendations highly preferred
- Ability to work independently involving management when needed is required
- Demonstrated ability and desire to teach others and share knowledge is required
Janssen Pharmaceutica N.V. (7555)