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Aishwarya shamu Guttedar

@aishwaryashamugutted

Medical writer in clinical research who prepared Phase II/III documentation and helped reduce clinical data discrepancies by 30%.

India

Message

At Accurate Health Group, I developed and reviewed medical, clinical, and scientific documentation for Phase II/III research programs. I helped improve documentation quality through systematic review processes, contributing to a 30% reduction in data discrepancies.

At Mobelchem Specialty Pvt. Ltd., I prepared clinical and regulatory documents and researched medical information across oncology, cardiovascular, dermatological, and other therapeutic areas. I also supported participant-facing materials for 150+ participants and trained research assistants on documentation standards and data quality.

My projects include a simulated Phase III oncology Clinical Study Report, a medical literature review and evidence synthesis, and a COVID-19 observational study analysis using Power BI. I hold a Master of Science in Health Data Analytics and a Bachelor of Dental Surgery.

Experience

Work history, roles, and key accomplishments

Medical & Scientific Documentation Specialist

Accurate Health Group

Sep 2024 - Feb 2026 (1 year 5 months)

Developed, reviewed, and refined medical, clinical, and scientific documentation for Phase II/III clinical research programs. Achieved a 98% first-submission IRB approval rate and contributed to a 30% reduction in data discrepancies.

Medical Writing Scientific Writing Clinical Documentation Regulatory Documentation ICH GCP FDA Regulation ALCOA+ Standards Good Documentation Practices (GDP)MedDRA Pharmacovigilance Clinical Data Review EDC TMF IRB Submission Microsoft Word PowerPoint Adobe Acrobat Power BI SQL

Medical Writing & Scientific Documentation Associate

Mobelchem Specialty Pvt. Ltd.

Mar 2022 - Dec 2023 (1 year 9 months)

Prepared and reviewed clinical, medical, scientific, and regulatory documentation supporting Phase II/III research programs. Trained 10+ research assistants on documentation standards and SOPs.