Plain Language Summary Writer

Job Duration: 6 Months+

Experience in writing clinical study reports in pharma (regulatory medical writing) and 2-3 years writing Plain language summaries under the new EU Clinical trial regulations.

Note:

What would you consider to be the top 3, non-negotiable skills that you'll be looking for when reviewing candidate resumes?

5 years’ experience writing Clinical study results.
3 years’ experience writing PLS of clinical trial results.
Proficiency in writing and speaking English, completed bachelor’s degree.

What would you consider to be an ideal candidate background for this position?

5 years’ experience writing Clinical study results, 3 years’ experience writing PLS of clinical trial results , proficiency in writing and speaking English, completed bachelor’s degree. The candidate needs to have 5 years’ experience as a regulatory medical writer writing clinical study reports and 3 years of plain language summary experience.

Description:

Plain Language Summary Writer

Write and review plain language summaries of clinical trial results.

General Summary: Reviews Plain Language Summaries of clinical trial results to ensure compliance with internal policy, regulatory standards, and health literacy principles. Project requires PLS training.

Duties and Responsibilities:

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 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.
Attends and facilitates cross-functional discussions by proposing solutions on guidelines, standards, processes and to resolve content issues.
Assists project team members in developing material for the study team kick-off meetings, assists with training needs.
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.
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.
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.

Educational requirements:

A university/college degree in relevant pharmaceutical/scientific experience is required.
A minimum of 3 years of relevant pharmaceutical/scientific experience in a clinical development environment (pharmaceutical, medical device, CRO or other clinical development service organization) is required.