Regulatory Medical Writer
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.