Senior Specialist,Digital Health Operations in High Wycombe

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Senior Specialist within our Digital Health Operations (DH OPs) team in the Post Approval Delivery Unit, to lead Digital Health activities across a range of technologies and serve as the primary point of contact for the cross-functional study team. This is a full-time, permanent, UK-based remote role.

Purpose: The Senior Specialist DH Ops will demonstrate technical expertise in system development, user acceptance testing, and will provide subject matter expertise to cross-functional study teams. The incumbent is expected to maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure Digital Health processes are at the ‘best practice’ level of performance.

You will be responsible for:

• Serving as a subject matter expert for Digital Health, providing advice/recommendations to study teams regarding the supplier(s) and device/technology alternatives.
• Completing Requests for Proposal documentation and recommending appropriate suppliers to support study needs.
• Providing leadership and expertise for the completion of supplier specification development and set-up activities through the lifecycle of the trial.
• Leading the cross-functional study team through changes of scope for Digital Health, providing technical expertise on the change of scope, assessment of risk, oversight of system requirements updates, and user acceptance testing.
• Assisting in the resolution of issues escalated by study teams for processes owned, as well as cross-team specific issues under the supervision of the Digital Health Delivery Unit Lead.
• Assisting with inspection readiness activities as needed.
• Monitoring key performance indicators (KPIs) for services provided by suppliers.
• Conducting Lessons Learned sessions following the completion of study start-up activities, and, as necessary, throughout other phases of the clinical development process.
• Effectively supporting the study team in close-out/deactivation of the Digital Health system and archive activities.
• Continually reviewing new emerging technologies focusing on efficiencies to be gained.
• Ensuring 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.

Principal Relationships:

• Internal – Global Development (GD), Therapeutic Areas (TA), JRP (Procurement), Legal, GCSO (Market Access), Regulatory, R&D Quality, IT, Quality – Computer System Validation (QCSV), Privacy, Security.
• External – Vendors, Copyright Holders.

Qualifications/Requirements:

• Bachelor’s degree (university degree) or equivalent education or relevant experience.
• At least 3 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 strategic planning is required.
• Familiarity with industry best practices for vendor management is required.
• Good understanding of the therapeutic areas where Janssen is involved is required.
• Experience with Digital Health Technology suppliers is preferred.
• Strong project management skills and presentation skills with the ability to lead a team independently.
• Strong written and communication skills in English.
• Ability to travel up to 10% of the time (domestic/international) is required.
• Microsoft Project skills would be an advantage.

Benefits: We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority; we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation.

All qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations.

Required Skills: Clinical Research Operations, Cross-Functional Team Leadership, Project Management, Vendor Management.

Preferred Skills: Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Emerging Technology Trends, Healthcare Technology, Inspection Readiness, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP), Strategic Planning, System Acceptance Testing.