プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

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☆☆☆☆☆

Dr. SENTHILKUMAR S.に依頼

India

Helping Medical Device Companies as an SME in developing CEP, CER, PMS Plan, PSUR, PMCF Plan & Report and Manuscripts

プロフィール概要

Scientific Writer with 10+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations and EU MDR. Skilled in writing and reviewing Clinical Evaluation Report (CER), Post-Market Surveillance (PMS) Plan & Report, Periodic Safety Update Report (PSUR), Post Market Clinical Follow-UP (PMCF) Plan & Report, Scientific Validity Report (SVR) and Clinical Performance Report (CPR). Also worked on several Manuscripts, Conference Abstracts, Safety Narratives, Slide Decks & Posters.

専門分野

• ★ European Medical Device Regulation (MDR)
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Regulatory Consulting
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Investigational Device Exemption (IDE)
• ☆ Manuscript & Journal Article Writing

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

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

職務経験

Technical Manager (Clinical COE)

HCL Technologies

7月 2018 - 4月 2020

Lead Scientific Writing

Indegene Pvt. Ltd.,

1月 2016 - 6月 2018

Senior Research Scientist

Frontier Lifeline Pvt. Ltd.,

4月 2011 - 12月 2015

学歴

Ph.D

University of Madras

1月 2008 - 現在

認定資格

• 認定資格の詳細は未入力です。