About this role
Job title: Informed Consent Writer
About the Role The Informed Consent Writer (ICW) at ICON develops informed consent documents for clinical trials using health-literate language to help candidates make informed participation decisions. The ICW collaborates across therapeutic areas, applying client tools, systems, guidelines, templates, and regulatory requirements to produce compliant, patient-friendly consent materials.
What You'll Do
- Read and understand protocol-specific design, objectives, and study procedures
- Prepare study-specific informed consent documents using established templates, protocol information, content libraries/glossaries, and required risk language
- Write, edit and review informed consent documents that reflect health-literacy principles
- Manage informed consent writing projects including design, planning, and preparation of documentation in support of clinical development
- Participate in clinical trial team meetings to ensure timely delivery and resolve issues related to informed consent documents
- Support Global Clinical Trial Operations with informed consent process expertise and study-specific support
- Potentially orient and coach junior team members; participate in initiatives to improve medical writing processes and standards
- Support tool development, enhancements, and testing; ensure compliance with training and time reporting
What We're Looking For
- Life sciences degree; 3-5 years relevant experience; demonstrated experience translating scientific material for a lay audience
- Understanding of protocol structure and regulatory guidance for informed consent (ICH and applicable regulations)
- Technical skills: MS Office (Word, Excel, Project); Adobe Acrobat; experience with document management systems and collaborative writing/review tools
- Knowledge of structured content management concepts; flexibility to adapt to new tools and technologies
- Ability to work in a deadline-driven environment, both independently and with teams
- Full fluency in reading and writing American English; excellent communication, time management, organizational and interpersonal skills; strong customer focus; solid project management
- Experience across multiple therapeutic areas and collaboration with cross-functional teams
Nice to Have
- Experience across multiple therapeutic areas
- Familiarity with health-literacy standards and client-specific content libraries
Compensation & Benefits
- Salary details not disclosed; benefits and other compensation components will be provided per ICON policies and applicable law.