Regulatory Medical Writing Evaluation
Job Description
Evaluate regulatory medical-writing tasks using clinical study reports, supporting tables and source evidence. Check document structure, internal consistency, claims and traceability against the applicable reporting standards, and explain revisions needed for a defensible submission.
Professional background
The preferred profile has at least five years in regulatory medical writing and independent responsibility for complete Clinical Study Reports, rather than only summaries. You should know ICH E3, E2F and E2C, eCTD organization, and how to reconcile narrative claims with protocols and tables/figures/listings. Precise editorial feedback and deep authoring experience are important. A relevant advanced life-science or clinical degree, or equivalent writing depth, is valued. Work across phases and indications is helpful, particularly oncology and hematology.
Working arrangements
This is remote, paid IXO expert work. Agree the specific task brief, permitted materials, outputs and working schedule with IXO before starting. Any commitment or duration described in a practice profile is an indicative planning requirement for that route, subject to that agreement.
Pay
$35 • $65/hr USD. The applicable rate is agreed for the work and professional track before you begin.
Use only materials you are authorized to share, and keep private or restricted information out of your submissions.