プロフィール詳細

プロジェクトを作成

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Jigar P.に依頼

India

Medical writer with 7 years of experience in clinical research.

プロフィール概要

Many thanks for visiting my profile. I have a total of 7 years’ experience in the writing area. Specialized in CSR writing for BA/BE, PK/PD, Transdermal, and Consumer product. As a writer, I am responsible for the generation of Clinical Study Report (CSR) as per ICH (E3), protocol, clinical raw data, sponsor /regulatory requirements. Also responsible for Planning, organization, coordination, and execution for CSR, compilation, and any other relevant task as per sponsor and regulatory requirements. To ensure that clinical study reports prepared as per sponsor and regulatory requirements. Handle sponsor’s or regulatory queries related to the clinical study reports. Also, prepare the protocol based on the GCP and regulatory requirements. I have prepared m2 and m5 Modules of common technical documents. During this tenure, 500+ CSR are prepared for the following types of studies. • BA/BE studies (2, 3, 4-way crossover, Parallel, Multiple-dose) • Consumer Products (Cream, Ointments, etc.) • Dose-Response Curve studies (DRC) • Vasoconstriction studies • Phase I to III • Dermatology (Adhesion, Irritation) studies • HRIPT Studies • m2 and m5 Modules of common technical documents.

専門分野

• ★ Regulatory Writing
• ★ Clinical Study Reports
• ★ Medical Writing
• ☆ Clinical Trial Protocol Writing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Market Research, Feasibility Study

Consulting Regulatory Consulting

Product Development Formulation

職務経験

Freelance - Medical writer

Rama Medical services and consultancy

1月 2021 - 現在

学歴

M.Sc. in Microbiology

Gujarat Vidhyapeeth

6月 2009 - 4月 2011

認定資格

• 認定資格の詳細は未入力です。