Regulatory Medical Writer — CSRs & DSURs Expert (Remote)

IXO Inc.; France; Remote; EUR 39,000 - 77,000; Full time

Job summary

IXO Inc. seeks a regulatory medical writer who can evaluate clinical regulatory documents and develop precise, data-supported medical writing. You will create review tasks using CSRs, DSURs and PSUR/PBRER documents to ensure accuracy and compliance.

Ideal candidates have extensive experience with ICH guidelines (E3, E2F, E2C) and eCTD knowledge, strong interpretation of efficacy/safety data, and the ability to trace conclusions to source evidence. Remote work available.

Qualifications

• Ability to evaluate clinical regulatory writing and trace narrative conclusions to source evidence.

Responsibilities

• Create review tasks using CSRs, DSURs and PSUR/PBRER documents.
• Assess ICH E3 organization, sections, references and appendices.
• Verify narrative claims against TFLs and protocols.
• Provide actionable explanations and improve regulatory-writing evaluation criteria.

Skills

Regulatory medical writing

Critical narrative critique

Evidence tracing

Regulatory document evaluation

Data interpretation

Education

Doctorate or master's in related field

Tools

eCTD knowledge

ICH guidelines familiarity

Job description

IXO Inc. seeks a regulatory medical writer who can evaluate clinical regulatory documents and develop precise, data-supported medical writing. You will create review tasks using CSRs, DSURs and PSUR/PBRER documents to ensure accuracy and compliance.

Ideal candidates have extensive experience with ICH guidelines (E3, E2F, E2C) and eCTD knowledge, strong interpretation of efficacy/safety data, and the ability to trace conclusions to source evidence. Remote work available.