Medical Writer

Naari Pharma; Dadri, Delhi, Gurugram District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Naari Pharma is seeking a Regulatory Medical Writer to develop high-quality clinical and regulatory documents in alignment with ICH, FDA, and EMA standards. You will collaborate cross-functionally to ensure accuracy and compliance for global submissions.

Responsibilities include authoring and reviewing CTD modules, CSRs, protocols, ICFs, and related regulatory deliverables to support BA/BE studies and regulatory submissions.

Qualifications

• Experience in regulatory writing for clinical and regulatory documents.
• Understanding of ICH, FDA, EMA guidelines is a plus.

Responsibilities

• Author and review clinical and regulatory documents (CTD Modules 2.4-2.7, CSRs, protocols, ICFs, BTIF/BSIF) to support global submissions.
• Collaborate cross-functionally to ensure regulatory compliance for BA/BE studies and submissions.

Job description

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.