- Experience in regulatory medical writing with expertise in CTD Modules, CSRs, protocols, and ICFs
- Author and review clinical and regulatory documents to support global submissions and ensure regulatory compliance
Role & responsibilities- Regulatory Medical Writer responsible for developing high-quality clinical and regulatory documents to support global submissions, ensuring compliance with ICH, FDA, and EMA requirements through cross-functional collaboration
Key Responsibilities
Author and review clinical and regulatory documents (CTD Modules 2.4-2.7, CSRs, protocols, ICFs, BTIF/BSIF) to support global submissions, BA/BE studies, and regulatory compliance.
📌 Medical Writer (Noida)
🏢 Naari Pharma
📍 Noida
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