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Plain Language Summary Writer - Remote, United States



Marketing & Communications
United States
Posted on Tuesday, April 16, 2024
Job Requirements

This posting has been created to pipeline talent for prospective roles that we anticipate will be needed in the future for our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.

The Health Literacy Specialist role in the Clinical Data Disclosure & Transparency (CDD&T) department will be primarily responsible for preparing Plain Language Summaries (PLS), including the Protocol PLS and Results PLS, of clinical studies per our company's process and standards to ensure compliance with internal policy, regulatory requirements, and health literacy principles.

Under the supervision of the CDD&T Health Literacy Projects Lead, the Specialist will be responsible for:

  • Authoring accurate, clear and health literate clinical trial PLS for posting on EU Clinical Trial Information System (EU CTIS) and other public registries where required by law or company commitment. These summaries will be for studies of varying complexity across therapeutic areas.
  • Developing PLS based on source documents (e.g., protocols, CSRs, Tables, Listings, and Figures), negotiating content with internal and external reviewers, and leading the summary through review and final approval.
  • Collaborating with clinical teams, requesting necessary data and information, and negotiating language to ensure it is health literate and non-promotional.
  • Responding to clinical and legal review comments on PLS; amending the summaries as required and facilitating approval within the required timelines for public posting.
  • Collaborating with Health Literacy team in the development and maintenance of plain language structured content and graphic libraries
  • Ensuring Project Leads and management are informed of any problems or unresolved issues that could affect compliance timelines or work quality.
  • Building expertise in the regulations associated with clinical trial PLS and adapting to the changing regulatory environment as needed.
  • Provide input and support to the Health Literate Glossary team.

Work Experience

Minimum Education Required:

  • Bachelor’s degree preferably in a life sciences related discipline

Required Experience and skills:

  • One year experience in plain language writing such as patient or public facing materials, PLS, or other health literate clinical research materials
  • Demonstrated team skills, professional values, and personal skills necessary for effective teamwork; able to work in cross-functional environment
  • Good communication and interpersonal skills (both oral and written) in order to interact clearly, effectively, and tactfully with stakeholders
  • High degree of organization and ability to manage simultaneous projects under tight timelines
  • Strong attention to detail, analytical/logical thinking skills; able to critically evaluate data
  • Ability to work independently and collaboratively in a team environment

Preferred skills:

  • Understanding of the principles of clinical research, fundamental statistics, and safety data reporting
  • Experience in translating scientific content into easy-to-understand text using health literacy and numeracy principles and sensitivity to the needs of audiences across cultures and communities
  • Background in medical writing, authoring International Council for Harmonization (ICH) clinical/regulatory documents (i.e., Informed Consents, Clinical Study Reports, Protocols, etc.)
  • Knowledge of International Council for Harmonization and Good Clinical Practice guidelines
  • Experience communicating medical and scientific information with patients or the public


Requisition ID:P-100806