Manager Clinical Data Transparency

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld 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 Med Tech, 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  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.

Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Data Governance & Policy

Job Category:
Professional

All Job Posting Locations:
Leiden, Netherlands

Job Description:

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 Med Tech, 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  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. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
The Netherlands

- Requisition Number: R-089963 United Kingdom
- Requisition Number: R-091258 India – Requestion Number: R-091259 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose:

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.

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., Clinical trials.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,…