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
- Valuable organizational and time management skills
- Ability to manage multiple deliverables and deadlines
- Attention to detail and qualit