Quality Control Medical Writing
On-siteSan Francisco, California, United States
San Francisco, California, United StatesOn-siteFull TimeSmall
Full TimeSmall
Job Summary
Evaluate AI-generated regulatory content quality and identify edge cases while deconstructing authoring, review, and QC heuristics for engineering teams. Bridge the gap between domain expertise in medical writing and technical product development by extracting and documenting rules and logic for technical developers. Ensure strict adherence to FDA, EMA, and ICH guidelines while managing CTD documents (non-clinical and CMC) within an in-office San Francisco role. Requires 3+ years of US-based regulatory medical writing experience.
Required Qualifications
- candidates MUST have at least 3 years of US-based experience in the US.
- 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.
- open to immediate relocation since these are IN-OFFICE in SF positions.
Desired Qualifications
- Familiarity with structured content formats like XML or JSON.
- Experience working with life sciences software tools.
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