Regulatory Medical Writer

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

Evaluate clinical regulatory documents and develop precise tests of data-supported medical writing.

What you will do

• Create review tasks using CSRs, DSURs and PSUR/PBRER documents.
• Assess ICH E3 organization, sections, references and appendices.
• Distinguish scientific misinterpretation in efficacy, safety, discussion and conclusions from stylistic choices.
• Verify narrative claims against TFLs and protocols.
• Provide actionable explanations and improve regulatory-writing evaluation criteria.

Required background

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

Preferred background

• At least five years of regulatory medical writing at a sponsor, CRO or as a consultant.
• Independent or lead authorship of full CSRs, beyond partial contributions.
• ICH E3, E2F, E2C and eCTD knowledge.
• Strong TFL/protocol interpretation and written/verbal critique.
• A relevant doctorate, medical or pharmacy qualification, or science master’s degree (PhD, MD, PharmD or MSc); comparable authoring expertise is also suitable.
• Experience across phases and therapeutic areas, especially oncology or hematology.

Availability

• Remote work; agree the assignment schedule before starting.

Pay and engagement

$32–$63/hr

Amounts are in USD. The applicable rate or fee and work requirements are agreed before you begin.