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J&J Family of Companies Manager Digital Health Enablement in England, United Kingdom

Manager Digital Health Enablement - 2406196447W

Description

Johnson & Johnson Innovative Medicine is recruiting for Senior Engineer Digital Health Enablement. The position can be located in Beerse, Belgium or High Wycombe, United Kingdom.

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 MedTech, 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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver important solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we champion a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

The Principal Engineer Digital Health Enablement (DHE) is primarily responsible for strategizing and leading the enablement of Digital Health (DH) data collection systems 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 system implementation, validation, maintenance, 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:

  • Lead project teams and could provide line management support of Digital Health Specialists.

  • Assist in recruiting, managing, coaching & mentoring of staff.

  • Conduct evaluation of potential candidates and serve as Janssen sponsor to flex employee(s).

  • Contribute to the vision, mission, and strategy of the Digital Health Enablement (DHE) team!

  • 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 system intake, maintenance, integration, and close-out.

  • Lead & support system qualification/validation initiatives to be performed for each technology/vendor.

  • Lead and support implementation projects for operational strategies, system automation, system integration, provisioning, and overall helpdesk support needs.

  • Support Digital Health Enablement (DHE) management in supplier category refreshes.

  • Provide technology 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 novel capability intakes, leading to fit-for-purpose implementations.

  • Manage scaling and handovers of novel capabilities into the scaled DH ecosystem.

  • Manage the DH Lessons Learned framework, providing operational & technical insights on existing and new DH capability implementations.

  • Ensure the Digital Health Enablement Portal is maintained as a current means of communication for all DH partners.

  • Enable optimal DH training for DH customers (internal DH teams, Sites, Participants).

  • Ensure optimized DH user experience (UX) strategies are implemented.

  • 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

At Johnson & Johnson, we are committed to fostering an inclusive and collaborative work environment. We believe in the power of diversity and are proud to be an equal opportunity employer. We welcome applications from individuals of all backgrounds and provide reasonable accommodations/adjustments for qualified individuals with disabilities.

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.

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Other Locations Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Organization Janssen Pharmaceutica N.V. (7555)

Job Function R&D Digital

Req ID: 2406196447W

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