Medical Writer (Pharmaceutical)
About the role
Experienced regulatory medical writers can help build AI writing tools for clinical documents. You'll create and review evaluation tasks based on Clinical Study Reports and safety reports, and judge whether AI written content is accurate and properly structured. No AI experience is needed; your medical writing skills are what count. AI Alerts may earn a referral fee if you're hired through this link. It costs you nothing and doesn't change how we pick or rank jobs.
What you'll do
- Write and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs or PBRERs and related clinical documents
- Check whether AI written content follows clinical templates and structure, including ICH E3 order, cross references and appendices
- Judge the scientific accuracy of efficacy, safety, discussion and conclusion sections, separating real errors from style differences
- Trace claims back to tables, figures, listings and protocols to confirm they're supported
- Write clear, structured reasons for each assessment
- Work with project leads to improve the evaluation approach
Requirements
- At least 5 years of regulatory medical writing at a sponsor, a CRO or as an independent consultant (preferred)
- Experience writing or leading full Clinical Study Reports, not just summaries
- Fluent with ICH E3, ICH E2F, ICH E2C and eCTD placement
- Able to read TFLs and protocols and spot where the narrative doesn't match the data
- Excellent written communication and structured feedback
- An advanced degree in life sciences, pharmacy or medicine (PhD, PharmD, MD or MSc), or equal authoring experience
- Experience across clinical phases; oncology and haematology are especially valued
About micro1
micro1 is a data lab that helps AI labs and large companies train AI models and agents. It finds and checks skilled people from many fields, like law, medicine, finance and coding, to produce the training data that makes AI work better.
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