- 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.
Required Skills:
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.
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.RequirementsMust Have...
- 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.
Required Skills:
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.
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