Manager Clinical Data Transparency

gned 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.

Proficiencies specific to the production of plain language summaries of clinical trial results:

• 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

Role Responsibilities:

• Ensures PLS production process is robust and scalable. Monitors vendor quality to identify weak points and develop solutions

• Interacts effectively with multiple functions, clinical teams across all Therapeutic Areas and external vendors to communicate document requirements and to provide high quality results

• Ensures compliance with departmental SOPs, Job Aids, policies and regulatory guidance documents

• Leads discussions by proposing solutions on guidelines, standards, processes

• Sound organizational and leadership skills, and the ability to balance multiple responsibilities and work under tight time constraints

• Responsible for vendor oversight, review of all draft PLSs, ensuring adherence to PLS compliance documents (i.e., PLS Template and Job Aid) and health literacy principles

• Leads discussions with cross-functional teams to address and resolve content issues

• Complete understanding of J&J's PLS policy and regulatory mandates. Communicates 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])

• Assesses impact of and applies, as appropriate, regional and/or local PLS content-related requirements and evaluates the impact with key stakeholders

• Ensures that results presentation is appropriate to the statistical analysis, and relevant for nonscientific readers, and includes sufficient context

• Understands the concerns around commercially confidential information, intellectual property and participant privacy issues in clinical trials

• Collaborates with teams who publish clinical trial results for alignment

• Prepares material and facilitates meetings with PLS production extended team members (i.e., PLS and ad-hoc Subject Matter Experts)

• Facilitates the timely hand-off of PLS for translation to begin

• Attends and actively participates in vendor(s) operational and governance meetings, raises issues to PLS Lead

• Assists in the updates of procedural documents, including the template, standard terms and definitions and Job Aids

• Identifies relevant program metrics to qualify/quantify project benefit, identify risks and areas of improvement

• Has strong oral/written communication and presentation skills

• The role must master the use of systems, tools, and processes

Qualifications

Qualifications & Experience:

Required:

• 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

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority. We offer career development opportunities for those who want to grow and be part of our organisation. We are J&J Innovative Medicine!

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.