Medical Regulatory Writer Needed
Budget: $10 – $30 USD
I’m looking for an experienced medical‐healthcare technical writer to draft a set of regulatory documents that will support an upcoming submission. You should already be comfortable interpreting clinical data, navigating FDA / EMA guidance, and translating complex study results into clear, compliant language that holds up to auditor scrutiny.
Scope
The immediate priority is a full regulatory package—including clinical evaluation sections, risk-benefit analyses, and accompanying summaries—prepared in line with current ICH and ISO standards. I will supply raw trial data, previous dossiers, and template headers; you will structure, write, and reference each section in Microsoft Word, using EndNote (or a similar citation manager) for sources.
Deliverables
• Draft regulatory dossier (all assigned sections)
• Clean, publication-ready Word files with tracked-changes history
• Reference list formatted per ICH requirements
• Final version incorporating my review comments
Acceptance criteria
• Content meets FDA and EMA formatting rules
• All claims supported by peer-reviewed or officially published data
• Zero unresolved reviewer comments and no grammar or style inconsistencies
Timeline and communication expectations are flexible, but I’d like to move quickly once we agree on an outline. If you have a proven record with medical submissions, I’m eager to see examples and discuss next steps.
Scope
The immediate priority is a full regulatory package—including clinical evaluation sections, risk-benefit analyses, and accompanying summaries—prepared in line with current ICH and ISO standards. I will supply raw trial data, previous dossiers, and template headers; you will structure, write, and reference each section in Microsoft Word, using EndNote (or a similar citation manager) for sources.
Deliverables
• Draft regulatory dossier (all assigned sections)
• Clean, publication-ready Word files with tracked-changes history
• Reference list formatted per ICH requirements
• Final version incorporating my review comments
Acceptance criteria
• Content meets FDA and EMA formatting rules
• All claims supported by peer-reviewed or officially published data
• Zero unresolved reviewer comments and no grammar or style inconsistencies
Timeline and communication expectations are flexible, but I’d like to move quickly once we agree on an outline. If you have a proven record with medical submissions, I’m eager to see examples and discuss next steps.