Senior Editor, Consent Form Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Perform thorough pre-review of new and updated consent forms to ensure compliance with FDA, HHS, Health Canada, TCPS2, ICH GCP standards, and Advarra procedures.

• Revise new and updated consent forms to meet regulatory compliance and adhere to Advarra guidelines.

• Implement agreed-upon sponsor and site language as detailed in mandatory language documents.

• Work collaboratively with Board members and staff to integrate essential edits from stakeholders.

• Conduct quality-control checks on informed consent documents for both personal and team submissions.

• Provide mentorship to new team members when requested.

• Enhance and maintain knowledge of regulations related to human subject protections, drug, device, and cosmetic research.

• Complete mandatory Human Subjects Research Training, including CITI training.

• Fulfill organizational training requirements as necessary.

• Attend one IRB meeting each month, or two during the initial training phase.

• Suggest process improvements to management.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

• A minimum of 2 years of experience in technical or medical writing and/or editing.

• Bachelor’s degree required.

• Experience in writing and/or editing consent forms or related research documentation.

• Proficient in word processing and editing tools, including Tracked Changes and Compare Merge features.

• Familiarity with Excel, PowerPoint, Slack or similar messaging platforms, Zoom or RingCentral, and web-based proprietary tools.

• Strong ability to communicate effectively and professionally in English, both verbally and in writing.

• Preferred: At least 1 year of experience with IRB processes.

• Preferred: Certification as an IRB Professional (CIP) or completion of CIP within two years of eligibility.

• Knowledge of U.S. and/or Canadian regulations and guidelines regarding human subject protections, drug, device, and cosmetic research.

• Understanding of scientific and medical terminology, with the ability to translate complex information into layman's terms.

• Capable of editing technical and/or medical documents.

• Competent in reading and understanding advanced technical or medical texts, including medical protocols and informed consent documents.

• Ability to manage several editing projects simultaneously while balancing competing priorities.

• Excellent attention to detail, accuracy, thoroughness, and strong problem-solving abilities.

• Ability to follow both written and verbal instructions and to work independently.

• Must be able to sit or stand for prolonged periods at a designated workstation.

• Must frequently lift, carry, and lower items weighing up to 10 lbs.

🏝️ Benefits

• Variable bonus eligibility in addition to base salary.

• Health insurance coverage.

• Paid holidays.

• Additional benefits.