Quality Control Medical Writing

• 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

Must Have Skills for Role:

• 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 Have Skills for Role:

Familiarity with structured content formats like XML or JSON.

Experience working with life sciences software tools.