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Quality Control Medical Writing - CTD documents
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-01-20
Listing for:
Talent Search PRO
Full Time
position Listed on 2026-01-20
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
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.
- 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.
- Familiarity with structured content formats like XML or JSON.
- Experience working with life sciences software tools.
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