Medical Writer

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.