Profile Details

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★★★★★

☆☆☆☆☆

USD 30 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Girish D.

India

USD 30 /hr

Medical writer with 14 years experience in regulatory writing, scientific writing, safety writing.

Profile Summary

Prepare and review clinical and scientific documents that are part of regulatory submission including Clicical Study protocols, Clinical Study Reports, IBs, IND modules, ANDA Module 2.7, Study Executive Summary, Clinical Trial Registry Summary, FDAAA, Narratives, and Post Approval Documents across the Therapeutic Areas. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document.

Subject Matter Expertise

• ★ Regulatory Writing
• ★ Medical Writing
• ★ Technical & Scientific Writing
• ☆ Clinical Study Reports
• ☆ Manuscript & Journal Article Writing

Services

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing, Newswriting

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis

Work Experience

Medical Writer

Spectrum Pharmaceutical Inc

July 2014 - July 2016

Education

Ph.D.

Mumbai University

July 1998 - July 2004

Certifications

• Certification details not provided.