Must Have Skills for Role:
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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