Job Title 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.
Job Description:
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.
