200+ applicants

Company

Original Job Post

Merck · 3 days ago

Plain Language Summary Writer

United States

Full-time

Remote

Entry, Mid Level

1+ years exp

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Responsibilities

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.

Qualification

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Plain language writingHealth literate clinical research materialsProject managementProblem-solvingTeamworkCommunicationInterpersonal skillsClinical Research PrinciplesStatisticsSafety Data ReportingHealth LiteracyMedical WritingICH Documents Clinical Practice GuidelinesCultural Sensitivity

Required

Bachelor’s degree preferably in a life sciences related discipline

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

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