Artificial Intelligence (AI), Biology, Content Structure, JSON, Medical Writing, Product Development, Quality Control, Regulations, Science Software, Technical Writing, XML (EXtensible Markup Language)
San Francisco, California
- 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.
S
Serene Healthcare Staffing