Clinical Data Transparency, International Registry Specialist 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.

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 Clinical Data Transparency, International Registry Specialist within our Integrated Data Analytics and Reporting (IDAR) team. This is a Hybrid position (3 days per week onsite, 2 days WFH) located within commutable distance of one of the following J&J sites: High Wycombe, United Kingdom; Madrid, Spain; Leiden, Netherlands or Beerse, Belgium.

The Clinical Data Transparency, International Registry Specialist serves as an individual contributor in Clinical Data Transparency, who works independently with minimal supervision helping to establish and implement projects, programs, and processes in support of the organization’s overall Clinical Data Transparency strategy. You will apply advanced knowledge of the Clinical Data Transparency field to establish best-in-class policies, procedures, and plans for the clinical registries, document anonymization and sharing or plain language summaries.

You will be responsible for:

• Helping establish and implement programs and innovative initiatives for the organization to advance Clinical Data Transparency initiatives.
• Contributing to projects, programs, or processes for the Clinical Data Transparency area.
• Integrating methods based on analyses of trends and the competitive landscape to continually improve the organization’s Clinical Data Transparency strategy.
• Participating in all aspects of Clinical Data Transparency including compliance with regulatory policies and privacy regulations.
• Researching critical data quality issues to drive root cause assessment and mitigation planning.
• Supporting development and maintenance of Clinical Data Transparency tools and activities.
• Coaching more junior colleagues in techniques, processes, and responsibilities.
• Understanding and applying J&J’s Credo and Leadership Imperatives in day-to-day interactions with the team.

The Clinical Data Transparency, International Registry Specialist:

• Project manages and coordinates disclosure activities for assigned studies.
• Coordinates assessments for protocol and results disclosures between the Compound Development Team or equivalent and the Clinical Registry Group (CRG), including amendments and special situations during the study progress.
• Develops, maintains, and obtains agreement with business partners for a clinical trial disclosure plan and manages the compliant execution of the plan.
• Tracks, reports and documents disclosure records and associated documents in tools and systems used by the CRG.
• Assists business partners, external partners and local operating companies in maintaining accurate and correct (source) data, relevant to the disclosure process.
• Maintains intelligence on the disclosure requirements for assigned countries. Creates a disclosure agreement with each country that is kept current with changing requirements.
• Supports one or several ancillary activities for the CRG, such as the patient referral process, (external) mailboxes or contact options from public facing websites.
• Supports the disclosure process for parts of the business that do not (entirely) follow the common CRG disclosure process, such as MedTech companies, Licensing & Acquisition projects or divestitures.

Principal Relationships:

• Internal: Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Legal, Global Privacy, and others as needed.
• External: Interact and collaborate with vendors.

Education and Experience Requirements:

• A bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience.
• At least 3 years of relevant pharmaceutical/scientific experience in a related discipline e.g. medical writing, data management, biostatistics, clinical programming.
• Strong understanding of at least one of the following: regulatory clinical trial disclosure requirements, translation of scientific content for a lay audience, anonymization of clinical data and documents, data sharing.
• Strong written and verbal communications skills.
• Demonstrated effective organizational skills, the ability to balance multiple responsibilities and work under tight time constraints.
• Demonstrated experience in contributing to cross-functional projects.
• Demonstrated customer focus.
• Demonstrated good interpersonal skills to build relationships with internal business partners.
• Demonstrated proficiency in the use of relevant systems, tools, and processes.
• Proficient in spoken and written English.

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 organization.

Johnson & Johnson Family of Companies are equal opportunity employers, and 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 accommodation.

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.