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Ranajit Roy
Senior Medical Writer
Senior Medical Writer
Ranajit Roy is a Senior Medical Writer with 9 years of experience specializing in patient narratives, Clinical Evaluation Reports (CERs/CEPs), and quality review of clinical study reports (CSRs). He leads cross-functional documentation projects end-to-end, collaborating with sponsors, mentoring writers, and ensuring high-quality, compliant deliverables across multiple therapeutic areas
FORMERLY AT
ICON Clinical Research
LOCATION
Bengaluru, India
AVAILABILITY
Full-time
Skills
Adverse Event Narratives
CER/CEP Authoring
Compliance Documentation
CSR QC Review
Database Management
Leadership & Client Coordination
MS Office
Narrative Authoring & QC
Protocol/Amendment Review
QC Review
Work Experience
Lead Medical Writer
HCL Technologies
December 2018 – February 2022
- Authored and reviewed Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and surgeon manuals for orthopedic and prosthetic implants.
- Managed team performance, documentation compliance, and client deliverables.
- Promoted based on performance and completed leadership skills certification.
TECHNOLOGIES
CER/CEP Authoring, Compliance Documentation, Leadership & Client Coordination
Junior Data Analyst
Cognizant Technology Solutions
August 2016 – December 2018
- Drafted and QC-reviewed adverse event narratives across oncology, cardiovascular, respiratory, and urology studies.
- Maintained narrative databases and cross-location reporting.
- Received multiple quality awards.
TECHNOLOGIES
Adverse Event Narratives, QC Review, Database Management
