• 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