Plain Language Summary Specialist


Job title: Plain Language Summary Specialist

Company: Johnson & Johnson

Job description: Job Description:

The overall responsibility of the Plain Language Summary (PLS) Specialist is to maintain the scientific integrity of the PLS of clinical study results that is aligned with Janssen’s compliance framework, and regulatory standards. The PLS must deliver a summary that is understandable to lay readers, fair, balanced, and non-promotional. The role works closely with the PLS Team to oversee vendor management in the production of the PLS including training materials and guidelines required for PLS development.

Principal Responsibilities:

  • Ensures PLS production process is robust and scalable. Monitors vendor quality to identify weak points and develop solutions
  • Complete understanding of Janssen’s PLS policy and regulatory mandates
  • Reviews PLSs to ensure compliance with internal policy, regulatory standards, and health literacy principles
  • Assist vendor oversight, review of all draft PLSs, ensuring adherence to PLS compliance documents (i.e., PLS Template and Job Aid), providing feedback, follow-up, and documentation
  • Assist in initiating and preparing for PLS endpoint discussion meetings and subsequent production-related meetings (i.e., kick-off meetings, comment review meetings) with the study and standards team in accordance with existing procedures
  • Ensures that results presentation is appropriate to the statistical analysis, and relevant for nonscientific readers, and includes sufficient context
  • Develops clear requirements for source documentation, acceptable study participant friendly and non-promotional language and use of visuals
  • Continually improve the PLS quality based on study participant feedback and experience
  • Understands the concerns around commercially confidential information, intellectual property and participant privacy issues in clinical trials
  • Assists in the updates of procedural documents, including the template, standard terms and definitions and Job Aids
  • Ensures compliance with departmental SOPs, Job Aids, policies and regulatory guidance documents
  • This position is expected to interact optimally with multiple functions, clinical teams across all Therapeutic Areas, and external vendors to communicate document requirements and to provide high quality results
  • Assesses impact of and applies, as appropriate, regional and/or local PLS content-related requirements and evaluates the impact with key stakeholders
  • Attends and faciliatates cross-functional discussions by proposing solutions on guidelines, standards, processes and to resolve content issues
  • Collaborates with teams who publish clinical trial results for alignment and relevant publications, as needed
  • Assists project team members in developing material for the study team kick-off meetings, assists with training needs
  • Collaborates with PLS Manager and study teams to confirm studies qualify under internal policy and mandatory criteria (i.e., national and regional requirements including EU Clinical Trial Regulation [EU CTR])
  • Attends and actively participates in vendor(s) operational and governance meetings, raises issues to PLS Lead
  • Leads and/or participates in PLS Community of Practice sessions and initiatives related to continuous improvement of internal processes, PLS content and additionally, shares learnings with colleagues related to development of the PLS
  • 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
  • Ensures all close-out activities have been executed according to internal policy
  • Identifies relevant program metrics to qualify/quantify project benefit, identify risks and areas of improvement
  • This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned

Principal Relationships:

Functional Contacts Inside the Company (as collaborator and peer): Reg MW TA leads, employees from other departments within Global Development, Quantitative Sciences, BioResearch Quality & Compliance, Janssen R&D Procurement and External Alliances.

TA Contacts Inside the Company (as collaborator): indirect contact

Contacts Outside the Company (as collaborator and/or advisor): Interacts with and oversees vendors. Act as J&J representative for defining process standards and sharing practices with industry counterparts and working groups.

A university/college degree in relevant pharmaceutical/scientific experience is required.

A minimum of 4 years of relevant pharmaceutical/scientific experience in a clinical development environment (pharmaceutical, medical device, CRO or other clinical development service organization) is required.

In addition, the following competencies are required:

  • Experience in translating scientific content into easy-to-understand terms following well understood health literacy and numeracy principles. Sensitivity to the needs of lay audiences
  • 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
  • Clear understanding of the requirements for source documentation, acceptable study participant friendly and non-promotional language and use of visuals
  • 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.,, 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
  • The role must master the use of systems, tools, and processes
  • Has strong oral/written communication and presentation skills
  • Sound organizational and management skills, and the ability to balance multiple responsibilities and work under tight time constraints

Primary Location
India-Maharashtra-Greater Mumbai-
Johnson & Johnson Private Limited (8080)
Job Function
Requisition ID

Expected salary:

Location: Mumbai, Maharashtra

Job date: Thu, 02 Jun 2022 05:44:01 GMT

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