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 protected]