Quality Control Medical Writing

Serene Healthcare StaffingSan Francisco, CA
4dOnsite

About The Position

Helping design AI systems that write regulatory documents. Deconstructing authoring/review/QC heuristics for engineers. Evaluating AI-generated content quality and identifying edge cases. Bridging the gap between domain expertise (medical writing) and technical product development.

Requirements

  • candidates MUST have at least 3 years of US-based experience in the US.
  • Additionally, if applicable, please explicitly state that the candidate is open to immediate relocation since these are IN-OFFICE in SF positions.
  • 3+ years of medical writing experience in regulatory affairs.
  • Direct experience with CTD documents (non-clinical and CMC).
  • Knowledge of FDA, EMA, and ICH guidelines.
  • Ability to extract and document rules/logic for technical teams.
  • Strong QC capabilities.

Nice To Haves

  • Familiarity with structured content formats like XML or JSON.
  • Experience working with life sciences software tools.
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