Profile Details

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★★★★★

☆☆☆☆☆

USD 75 /hr

★★★★★

☆☆☆☆☆

Hire Dr. SENTHILKUMAR S.

India

USD 75 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

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

Work Experience

Technical Manager (Clinical COE)

HCL Technologies

July 2018 - April 2020

Lead Scientific Writing

Indegene Pvt. Ltd.,

January 2016 - June 2018

Senior Research Scientist

Frontier Lifeline Pvt. Ltd.,

April 2011 - December 2015

Education

Ph.D

University of Madras

January 2008 - Present

Certifications

• Certification details not provided.