Informed Consent Writer
New
United StatesFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- American English
- Experience
- 3–5 years
- Required Skills
- MS Office
Requirements
- Bachelor’s degree in Life Sciences or related field
- 3–5 years of experience in medical writing, clinical research, or translating scientific content for lay audiences
- Strong understanding of clinical trial protocols and informed consent processes
- Knowledge of ICH guidelines and regulatory requirements related to informed consent
- Proficiency with MS Office tools (Word, Excel, Project) and Adobe Acrobat
- Experience with document management systems and collaborative authoring tools
- Excellent written and verbal communication skills in American English
- Strong organizational, time management, and project coordination abilities
- Ability to work independently while collaborating effectively across global teams
- Detail-oriented mindset with strong adherence to compliance and quality standards
Responsibilities
- Prepare and write informed consent documents using protocol details, templates, and regulatory guidance in clear, lay-friendly language
- Interpret clinical trial protocols to extract relevant study design, objectives, risks, and procedures for participant-facing materials
- Collaborate with protocol authors and clinical teams to ensure full understanding of study requirements and timelines
- Ensure compliance with International Council on Harmonization (ICH) guidelines and applicable regulatory standards for informed consent
- Manage informed consent documentation workflows, including drafting, editing, review cycles, and issue resolution
- Participate in clinical trial team meetings to support timely delivery of consent documentation
- Support continuous improvement initiatives, including process optimization, tool enhancements, and training support for junior staff
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