Medical Writer (Pharmaceutical)

What you'll do

The customer is building AI-assisted writing tools for regulatory clinical documents, and you are the experienced writer grading its drafts. You write and review evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs and related documents, and assess AI output on three levels:

• Template and structure: does it follow ICH E3 organisation, section order, cross-referencing and appendix handling?
• Scientific accuracy: are the efficacy, safety, discussion and conclusion narratives right, as opposed to merely phrased differently from how you would write them?
• Source fidelity: does every narrative claim trace to a table, figure, listing or protocol section?

Each assessment comes with a structured written rationale, and you help the project leads refine the evaluation framework and document good practice for regulatory writing with AI.

Separating true interpretive errors from stylistic difference is the core skill. Every regulatory writer has house-style opinions; the job is to set them aside and flag only what would fail QC or mislead a reviewer.

Who fits

• At least five years of regulatory medical writing at a sponsor, CRO or as an independent consultant
• Independent authorship, or leadership of authorship, of full Clinical Study Reports, not only summaries or sections
• Fluency with ICH E3, periodic safety conventions (ICH E2F, ICH E2C) and eCTD placement
• The ability to read TFLs and protocols and spot where narrative diverges from data
• Excellent written and verbal communication, with actionable feedback
• An advanced degree (PhD, PharmD, MD, MSc) in life sciences, pharmacy or medicine, or equivalent authoring depth
• Breadth across phases and therapeutic areas; oncology and haematology especially valued

What it pays

$30–60/hour, micro1's published figure. That is low for a writer with full-CSR authorship, and it sits below the $50–80 paid on micro1's Clinical Publications Author and Medical Communications Manager listings, whose bars are comparable. The band doubles from floor to top with no stated basis for placement. No compensation structure, weekly hours or duration is stated.

Worth knowing

Good:

• Thirty openings, flagged high demand
• Independent consultants explicitly qualify
• Equivalent authoring depth can substitute for an advanced degree
• Directly uses skills regulatory writers already have

Less good:

• Pay is well below typical senior regulatory writing rates, and below micro1's sibling medical writing listings
• Full CSR authorship is a hard filter
• No hours, duration or pay structure published
• Contractor engagement: no benefits, no notice period, your own tax to manage
• The tools being built automate part of regulatory writing, which some writers will want to weigh

About this listing

Posted by micro1 on its own jobs portal and read on 24 September 2026. The $30–60/hour band, thirty openings, five-year floor and CSR authorship requirement are its own published text. Location is given only as remote with no country restriction, so eligibility is left open. Payment terms and schedule are not published on the listing. Related: Clinical Publications Author. See micro1.