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.

Qualifications

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

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.