Medical Writer (Pharmaceutical)

pay

Required Skills
regulatory medical writing
clinical study report authoring
ich e3 guidelines
scientific accuracy assessment
source data verification
clinical protocol interpretation
tfl (tables, figures, listings) analysis
written communication
structured feedback provision
collaborative problem-solving
ai-assisted documentation evaluation
periodic safety documentation (ich e2f, ich e2c)
ectd (electronic common technical document) knowledge
oncology and haematology domain expertise
About micro1
micro1 is the leading AI data lab for training frontier models and evaluating AI agents. Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more. micro1 transforms that real-world expertise into high-quality training data, evaluations, and feedback loops that improve how AI systems learn, reason, and perform.

Our platform identifies and vets top talent through an AI recruiter, enabling high-quality expert contributions at scale. We aim to enable 1 billion people to do meaningful work by applying their expertise to AI. As our global expert network grows, micro1 is building the human intelligence layer for frontier AI.

Role Title: Medical Writer (Pharmaceutical)

Role Type: Contractor

Location: Remote

micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.

Scope of Work

Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.

Preferred Qualifications

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.

Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.

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