Informed Consent Writer

Job Summary

Responsible for preparing informed consent documents in a remote, full-time capacity, the Informed Consent Writer will ensure clarity and health literacy in clinical trial information, collaborating across therapeutic areas and managing writing projects with minimal supervision.

Key responsibilities

• Read and understand protocol-specific design, objectives, and study procedures to prepare informed consent documents
• Collaborate with protocol authors to ensure comprehensive understanding and timely delivery of informed consent documents
• Manage informed consent writing projects, including design, planning, and documentation preparation in support of clinical development

Required qualifications

• Life sciences degree
• 3-5 years of relevant experience, including experience translating scientific material for a lay audience
• Technical expertise in MS Office and Adobe Acrobat, with experience in document management systems
• Understanding of International Council on Harmonization (ICH) guidelines and regulatory requirements for informed consent
• Ability to work in a deadline-driven environment both independently and collaboratively