Quality Control Medical Writing - CTD documents experience

Company: Talent Search PRO
Location: San Francisco
Posted on: April 2, 2026

Job Description:

Scope/Responsibilities of Role: 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. Must Have Skills for Role: 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 Have Skills for Role: Familiarity with structured content formats like XML or JSON. Experience working with life sciences software tools.

Keywords: Talent Search PRO, Oakland , Quality Control Medical Writing - CTD documents experience, IT / Software / Systems , San Francisco, California

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