Remote Regulatory Medical Writer – AI-Assisted Clinical Docs

micro1; United States; Remote; USD 41.000 - 83.000; Teilzeit

Benefits dieser Stelle

Remote work

Zusammenfassung

micro1 is a remote, contractor role seeking a Medical Writer (Pharmaceutical) to support AI-assisted clinical documentation projects. You will author and review Clinical Study Reports, safety documents, and regulatory submissions with emphasis on ICH E3 structure and eCTD placement.

Ideal candidates have 5+ years in regulatory medical writing, oncology/haematology knowledge, and strong written communication. Remote engagement with global teams is expected.

Qualifikationen

• Regulatory medical writing for clinical documents and safety reports.
• Analyze and ensure adherence to ICH E3 structure, sequencing, and appendices.
• Verify that narrative content aligns with source data from tables/figures/listings.

Aufgaben

• Author and review Clinical Study Reports, DSURs, PSURs/PBRERs and related clinical docs to inform AI tool development.
• Assess AI-generated content against clinical templates and ICH organization requirements.
• Evaluate narrative accuracy in efficacy and safety sections and distinguish errors from style.
• Trace narrative claims to source records and verify support.
• Provide structured rationales to support AI model improvement.
• Collaborate to refine evaluation frameworks for clinical regulatory writing in AI context.

Kenntnisse

regulatory medical writing

clinical study report authoring

ICH E3 guidelines

scientific accuracy assessment

source data verification

clinical protocol interpretation

TFL analysis

written communication

structured feedback provision

collaborative problem-solving

AI-assisted documentation evaluation

ICH E2F/E2C safety docs

eCTD knowledge

oncology/haematology domain

Jobbeschreibung

micro1 is a remote, contractor role seeking a Medical Writer (Pharmaceutical) to support AI-assisted clinical documentation projects. You will author and review Clinical Study Reports, safety documents, and regulatory submissions with emphasis on ICH E3 structure and eCTD placement.

Ideal candidates have 5+ years in regulatory medical writing, oncology/haematology knowledge, and strong written communication. Remote engagement with global teams is expected.