Manager Digital Health Enablement

Johnson & Johnson Innovative Medicine is recruiting for Principal Engineer Digital Health Enablement. The position can be located in Beerse, Belgium; High Wycombe, United Kingdom; Spring House, USA, other locations to be evaluated. The Principal Engineer Digital Health Enablement (DHE) is primarily responsible for strategizing and leading the enablement of Digital Health (DH) data collection capabilities supporting clinical trial activities operationalized by our partners within the Delivery Units (DUs) of Global Development. The incumbent would primarily be required to support the Head of the department and provide a level of subject matter expertise in DH capability implementation, qualification, oversight, issue management, have strong strategic insights and provide subject matter expertise to cross functional study teams via targeted projects. In addition, leading strategic projects is a stronghold of the DHE team, including creation of supporting DH tools for tracking, measuring, training, continuous improvement, governance, process, and oversight purposes. The individual requires working closely with other DHE team members and relevant internal DH partners to ensure system impact is assessed and mitigation strategies are in place where applicable. The expectation is to have a clear understanding of clinical trials and internal and external cross-functional partners, as well as maintain an awareness of industry benchmarks, external practices, and regulations, to ensure DHE processes are at the 'best practice' level of performance. Responsibilities:

• Contribute to the vision, mission, and strategy of the Digital Health Enablement (DHE) team!
• Assist in recruiting, managing, coaching & mentoring of internal & external staff.
• Drive and inspire project teams to achieve exceptional results, by supporting implementation projects for operational strategies.
• Serve as a subject matter expert for Digital Health, providing advice/recommendations to study teams regarding the supplier(s) and device/technology options.
• Provide leadership and expertise supporting DH capability intake, governance, scaling, and close-out.
• Lead & support digital health technology qualification initiatives for each technology/vendor.
• Support Digital Health Enablement (DHE) management in supplier category refreshes.
• Provide supplier capability oversight, issue management, oversight of supplier roadmaps, and act as liaison with the DUs and Partnerships.
• Lead cross-functional projects with broad cross-functional impact and drive structured improvements to digital health related processes in line with business and operational strategy.
• Provide oversight for & potential scaling of novel digital health technologies, leading to fit-for-purpose implementations supporting the DH ecosystem.
• Contribute to the DH Lessons Learned framework, providing operational & technical insights on existing and new DH capability implementations.
• Give input into QMS documentation reviews and updates (including internal QMS Impact Assessments, and external industry Guidance Document reviews/Impact Assessments).
• Lead/support audit trail reviews and support System & GCP Audits, and Regulatory body Inspections.
• Ensure DH Metrics are available, shared and interpreted to enable robust data-driven DH decision making and compliance monitoring.
• Represent Digital Health as a Digital Health subject matter expert at internal cross-company meetings and at external professional meetings.
• Ensure that the 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., The Principal Engineer Digital Health Enablement (DHE) is primarily responsible for strategizing and leading the enablement of Digital Health (DH) data collection capabilities supporting clinical trial activities operationalized by our partners within the Delivery Units (DUs) of Global Development. The incumbent would primarily be required to support the Head of the department and provide a level of subject matter expertise in DH capability implementation, qualification, oversight, issue management, have strong strategic insights and provide subject matter expertise to cross functional study teams via targeted projects. In addition, leading strategic projects is a stronghold of the DHE team, including creation of supporting DH tools for tracking, measuring, training, continuous improvement, governance, process, and oversight purposes.
The individual requires working closely with other DHE team members and relevant internal DH partners to ensure system impact is assessed and mitigation strategies are in place where applicable. The expectation is to have a clear understanding of clinical trials and internal and external cross-functional partners, as well as maintain an awareness of industry benchmarks, external practices, and regulations, to ensure DHE processes are at the 'best practice' level of performance. Responsibilities:
• Contribute to the vision, mission, and strategy of the Digital Health Enablement (DHE) team!
• Assist in recruiting, managing, coaching & mentoring of internal & external staff.
• Drive and inspire project teams to achieve exceptional results, by supporting implementation projects for operational strategies.
• Serve as a subject matter expert for Digital Health, providing advice/recommendations to study teams regarding the supplier(s) and device/technology options.
• Provide leadership and expertise supporting DH capability intake, governance, scaling, and close-out.
• Lead & support digital health technology qualification initiatives for each technology/vendor.
• Support Digital Health Enablement (DHE) management in supplier category refreshes.
• Provide supplier capability oversight, issue management, oversight of supplier roadmaps, and act as liaison with the DUs and Partnerships.
• Lead cross-functional projects with broad cross-functional impact and drive structured improvements to digital health related processes in line with business and operational strategy.
• Provide oversight for & potential scaling of novel digital health technologies, leading to fit-for-purpose implementations supporting the DH ecosystem.
• Contribute to the DH Lessons Learned framework, providing operational & technical insights on existing and new DH capability implementations.
• Give input into QMS documentation reviews and updates (including internal QMS Impact Assessments, and external industry Guidance Document reviews/Impact Assessments).
• Lead/support audit trail reviews and support System & GCP Audits, and Regulatory body Inspections.
• Ensure DH Metrics are available, shared and interpreted to enable robust data-driven DH decision making and compliance monitoring.
• Represent Digital Health as a Digital Health subject matter expert at internal cross-company meetings and at external professional meetings.
• Ensure that the 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.