プロフィール詳細

プロジェクトを作成

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Dr. Girish D.に依頼

India

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

プロフィール概要

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.

専門分野

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

サービス

• 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

職務経験

Medical Writer

Spectrum Pharmaceutical Inc

7月 2014 - 7月 2016

学歴

Ph.D.

Mumbai University

7月 1998 - 7月 2004

認定資格

• 認定資格の詳細は未入力です。