Safety Narrative Writer

Job Description Clinical Study Narrative Writer

Global Drug Development / Global Regulatory Sciences / GSRD
Location: Hyderabad, India

Position Summary

The role involves writing, editing, reviewing, finalizing, and tracking clinical study report (CSR) patient safety narratives in support of global clinical development and regulatory submissions.

Key Responsibilities

• Write, edit, review, and finalize CSR patient safety narratives
• Serve as the primary contact for narrative writing for assigned clinical studies
• Manage timelines, deliverables, and narrative-related issue resolution
• Prepare clear and accurate narratives based on:
• Clinical database outputs
• Safety database outputs
• Ensure medical consistency and scientific accuracy in narratives
• Perform quality control checks, formatting, and compilation of documents
• Participate in process improvement initiatives for patient safety narrative development
• Ensure deliverables meet regulatory and quality standards

Required Qualifications

Education

• Bachelor’s or Master’s degree in:
• Biomedical Sciences
• Life Sciences
• Pharmacy / related scientific fields (preferred)

Experience

• 2–5 years of experience in:
• Clinical documentation
• Clinical data interpretation
• Pharma / biotech / CRO environment
• Experience in clinical study reporting or medical writing preferred

Required Knowledge & Skills

• Basic understanding of:
• Global regulatory guidelines (FDA, ICH)
• Drug development process
• Knowledge of:
• eCTD (electronic Common Technical Document)
• Clinical study documentation standards
• Strong ability to:
• Summarize complex medical/clinical data clearly
• Write concise and scientifically accurate narratives
• Experience using:
• Electronic Document Management Systems (EDMS)
• PDF annotation tools

Soft Skills

• Strong written and verbal communication skills
• Good organizational and time management skills
• Ability to manage multiple deliverables and deadlines
• Attention to detail and quality-focused mindset
• Ability to work in a matrix environment
• Strong collaboration with cross-functional teams

Interested candidates can share their updated resume at [email removed]