Job title: Plain Language Summary Specialist
Company: Johnson & Johnson
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
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. Proficiencies specific to the production of plain language summaries of clinical trial results: Takes a proactive role 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 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 General Requirements The role must master the use of systems, tools, and processes Ensures production process is robust and scalable. Monitors vendor quality to identify weak points and develop solutions This position is encouraged 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 Leads discussions by proposing solutions on guidelines, standards, processes Ensures compliance with departmental SOPs, Job Aids, policies and regulatory guidance documents 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 Responsible for 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. Reviews PLSs to ensure compliance with internal policy, regulatory standards, and health literacy principles Leads discussions with cross-functional teams to address and resolve content issues Complete understanding of Janssen’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]), collaborates closely with EU CTR transition teams Assesses impact of and applies, as appropriate, regional and/or local PLS content-related requirements and evaluates the impact with key stakeholders Responsible for 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 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 Assists project team members in developing material for the study team kick-off meetings, assists with training needs 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 Ensures all close-out activities have been executed according to internal policy 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 Qualifications Bachelor’s degree or equivalent in science. Advanced Degree (Master’s, PhD or equivalent preferred). Atleast 8 years of experience in Plain Language Summary within the pharmaceutical / clinical trail environment with proven in a leadership role and ideally within the region. Strong project management and cross functional experience Primary Location India-Maharashtra-Greater Mumbai- Organization Johnson & Johnson Private Limited (8080) Job Function R&D Requisition ID 2206006474W
Location: Mumbai, Maharashtra
Job date: Wed, 09 Feb 2022 23:41:25 GMT
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