Manager Digital Health Enablement

Johnson & Johnson - Spring House, PA

Full-time - Senior

Spring House, PA

Chemical Manufacturing

About the position

The Principal Engineer Digital Health Enablement (DHE) at Johnson & Johnson is responsible for strategizing and leading the implementation of Digital Health data collection capabilities to support clinical trial activities. This role involves providing subject matter expertise, managing strategic projects, and ensuring best practices in digital health processes. The incumbent will work closely with cross-functional teams and internal partners to assess system impacts and develop mitigation strategies, while also contributing to the overall vision and strategy of the DHE team.

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.

Requirements

• Bachelor's degree (University degree) or equivalent education/relevant experience required.
• At least 8 years operational experience in clinical trials with a pharmaceutical company and/or a Clinical Research Organization is required.
• Demonstrated knowledge of clinical development processes, global clinical operations and industry standard processes is required.
• Good understanding of the therapeutic areas where J&J is involved is required.
• Experience with DH self service providers, digital platforms and technologies is preferred.
• Demonstrate a passion for digital technologies and how these are implemented in clinical studies.
• Experience in developing use cases and user requirement specification documents.
• Ability to lead a project team independently.
• Thrive in a fast-paced environment requiring excellent problem-solving skills, capacity to manage multi-project completion under short deadlines, demonstrate decision-making, presentation skills and the ability to communicate with clients and end users.
• Ability to quickly understand complex systems and be able to explain them to varied partners.
• Excellent in speaking and writing in English. Effective communication skills, oral and written.
• Strong Project Management and presentation skills.

Nice-to-haves

• Experience with digital health technologies and platforms.
• Familiarity with industry benchmarks and regulations related to digital health.

Benefits

• Comprehensive health insurance coverage.
• Opportunities for professional development and career growth.
• Flexible working arrangements.
• Support for employee wellness programs.