Informed Consent Writer

ICON plc

Informed Consent Writer at ICON plc preparing informed consent documents for clinical trials. Ensuring clarity and adherence to health literacy in compliance with clinical research standards.

Posted 5/13/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Read and understand protocol-specific design, objectives, and study procedures
Prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk language
Work with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline
Write, edit and review informed consent documents that reflect the principles of health literacy
Manage informed consent writing projects including the design, planning, and preparation of documentation in support of clinical development
Participate, when appropriate, in clinical trial team meetings to ensure timely delivery of the informed consent document(s)
Resolve document issues relating to informed consent
Support Global Clinical Trial Operations with informed consent process expertise and study specific support
Possible participation in the orientation and coaching of junior team members
Possible participation in initiatives to improve medical writing processes and standards
Support tool development, enhancements, and testing, as applicable
Ensure compliance with company training and time reporting

Requirements

What you’ll need

Life sciences degree
3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience
Scientific Knowledge/Health Literacy
Understanding of protocol structure and knowledge of the relevant information needed to create an informed consent document
Understanding of clinical trial operations with specific knowledge of informed consent forms
Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities for a lay audience using established guidelines and governmental regulations in a clear, concise and health-literate format
Understanding of appropriate International Council on Harmonization (ICH) and regulatory guidance pertaining to Informed Consent
Technical expertise in MS Office (Word, Excel, Project) and Adobe Acrobat
Experience working in document management systems; managing workflows
Experience with collaborative authoring and review tool
Understanding of structured content management concepts
Ability to work in a deadline-driven environment, and ability to work both independently and collaboratively with teams
Complete fluency in reading and writing American English
Excellent communication skills (email responses, meeting presentations)
Effective time management, organizational, and interpersonal skills
Customer focus
Strong project management skills.

Benefits

Comp & perks

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

scientific knowledgehealth literacyprotocol structure understandingclinical trial operations knowledgeinformed consent document preparationdocument management systemsstructured content managementproject management

Soft Skills

communication skillstime managementorganizational skillsinterpersonal skillscustomer focusability to work independentlycollaborative teamworkdeadline-driven environment adaptability

Certifications

life sciences degree