Regulatory Affairs Lead for AI-Driven Docs (Remote, Flexible)

Ethos

España

Remote

EUR 111,000 - 147,000

Full time

2 days ago
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Job summary

Ethos, a network connecting experts with investors and consultancies, seeks heads of regulatory affairs to train an AI model on professional documents, spreadsheets, and slide decks for clinical and regulatory workflows. You will contribute expert insights and ensure accuracy across materials.

This fully remote role offers flexible hours (5-20 per week) with ASAP start; responsibilities include drafting and reviewing CSRs, protocol synopses, investigator brochures, regulatory modules, medical

Qualifications

  • Direct experience authoring or reviewing clinical study reports, protocol synopses, or regulatory dossier modules for a pharmaceutical, biotech, or CRO organization
  • Deep familiarity with ICH-GCP standards, FDA/EMA regulatory expectations, and the scientific rigor required in investigator brochures and medical affairs materials
  • Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail

Responsibilities

  • Create, evaluate, and refine AI-generated clinical documents, spreadsheets, and slide decks across core workflows.
  • Ensure compliance with regulatory standards in all prepared materials.
  • Collaborate with clients on regulatory submissions and medical affairs communications.

Skills

Regulatory affairs
ICH-GCP
Clinical study reports

Job description

Ethos, a network connecting experts with investors and consultancies, seeks heads of regulatory affairs to train an AI model on professional documents, spreadsheets, and slide decks for clinical and regulatory workflows. You will contribute expert insights and ensure accuracy across materials.

This fully remote role offers flexible hours (5-20 per week) with ASAP start; responsibilities include drafting and reviewing CSRs, protocol synopses, investigator brochures, regulatory modules, medical

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