job title: narrative medical writer(excelya)

Responsibilities:

• Prepare and review safety narratives for clinical study reports (CSRs) and other regulatory requirements.

• Collaborate with cross-functional teams, including safety, medical monitoring, and clinical operations, to gather and interpret relevant data.

• Ensure narratives comply with international regulatory guidelines and sponsor-specific requirements.

• Maintain high-quality documentation standards while meeting tight deadlines.

  Minimum Requirements :

  • 2+ years of experience in medical writing in the preparation of safety narratives.

  • Strong understanding of regulatory requirements for clinical safety reporting.

  • Excellent written communication skills with a keen eye for detail across multiple sources.