Manager Clinical Data Transparency 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.

We are searching for the best talent for a Manager Clinical Data Transparency / Plain Language Summary (PLS) Manager to join our Clinical Data Standards & Transparency team/ Innovative Medicine, to be located in High Wycombe / Maidenhead, United Kingdom; Leiden, The Netherlands; or Mumbai / Hyderabad, India. This is a hybrid role requiring 3 days per week onsite, therefore commutability to one of these locations is essential. We are open to considering candidates on either a 0.8 FTE or full-time (1.0 FTE) basis.

The overall responsibility of the PLS Manager is to maintain the scientific integrity of clinical study results, aligned with J&J's compliance framework and regulatory standards, and deliver a summary that is understandable to lay readers in a fair, balanced, and non-promotional manner.

• Knowledge of the application of regulatory guidance (i.e., EU Clinical Trial Regulations) in writing PLSs
• Understands the principles of clinical research, fundamental biostatistics, and safety data reporting
• Interprets information for indications across various therapeutic areas using source documents such as the protocol, Clinical Study Report but also the Informed Consent Forms, Technical Summaries of Clinical Trial Results (i.e., Clinicaltrials.gov, EudraCT)
• Applies critical scientific thinking to align the study rationale and research objectives with study endpoints and results.
• Understands the trial design, disease characteristics and measures being summarized to ensure study results accurately present scientific content in plain language
• Experience in writing Clinical Study Reports

You Will Be Responsible For:

• Ensuring PLS production process is robust and scalable.
• Monitoring vendor quality to identify weak points and develop solutions
• Interacting effectively with multiple functions, clinical teams across all Therapeutic Areas and external vendors to communicate document requirements and to provide high quality results
• Ensuring compliance with departmental SOPs, Job Aids, policies and regulatory guidance documents
• Leading discussions by proposing solutions on guidelines, standards, processes
• Possessing sound organisational and leadership skills, and the ability to balance multiple responsibilities and work under tight time constraints
• Vendor oversight, reviewing all draft PLSs, ensuring adherence to PLS compliance documents (i.e., PLS Template and Job Aid) and health literacy principles
• Leading discussions with cross-functional teams to address and resolve content issues
• Completing understanding of J&J's PLS policy and regulatory mandates.
• Communicating effectively with team members to confirm studies qualify under internal policy and mandatory criteria (i.e., national and regional requirements including EU Clinical Trial Regulation [EU CTR])
• Assessing impact of and applying, as appropriate, regional and/or local PLS content-related requirements and evaluates the impact with key stakeholders
• Ensuring that results presentation is appropriate to the statistical analysis, and relevant for nonscientific readers, and includes sufficient context
• Understanding the concerns around commercially confidential information, intellectual property and participant privacy issues in clinical trials
• Collaborating with teams who publish clinical trial results for alignment
• Preparing material and facilitating meetings with PLS production extended team members (i.e., PLS and ad-hoc Subject Matter Experts)
• Facilitating the timely hand-off of PLS for translation to begin
• Attending and actively participating in vendor(s) operational and governance meetings, raising issues to PLS Lead
• Assisting in the updates of procedural documents, including the template, standard terms and definitions and Job Aids
• Identifying relevant program metrics to qualify/quantify project benefit, identifying risks and areas of improvement
• Possessing strong oral/written communication and presentation skills
• Mastering the use of systems, tools, and processes

Education & Experience Requirements:

• A Bachelor’s degree in a scientific, technical or healthcare subject area, or equivalent experience is required.
• At least 5 years in relevant pharmaceutical/scientific experience in a related field; e.g. medical writing, PLS writing
• Excellent understanding of at least one of the following: regulatory clinical trial disclosure requirements, translation of scientific content for a lay audience
• Demonstrated written and verbal communications skills is required
• Demonstrated customer focus and solution-oriented experience required
• Proficient English written and spoken

Preferred:

• Demonstrated interpersonal skills to build relationships with internal and external business partners
• Demonstrated leadership on cross-functional projects.
• Demonstrated leadership in strategic decision making and problem solving

We offer a competitive salary and extensive benefits package. 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. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.