Profile Details

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USD 100 /hr

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Hire Ramamurthy J.

India

USD 100 /hr

End-to-End writing and project life cycle management of CEP/CER, PMSP/PMSR/PSUR, PMCFP/PMCFER and SSCP

Profile Summary

▪ Writing, reviewing quality and ensuring timely delivery of CEP/CER, PMSP/PMSR/PSUR to the client according to EU-MDR/MDD regulations and related MEDDEV guidelines. ▪ Led and supported initiatives focused on quality, process and compliance improvement. ▪ Served as the senior medical writer and delivery lead on assigned projects to meet all project timelines

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ★ Clinical Evaluation Reports (CER)
• ★ Medical Writing
• ☆ Pharmacovigilance/Drug Safety Monitoring

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Technical Writing

Research Market Research, Meta-Research, Systematic Literature Review

Consulting Regulatory Consulting

Data & AI Data Processing

Work Experience

Specialist Medical Writing

Actalent

July 2021 - Present

Education

M.Sc Biochemistry

Annamalai University

June 2005 - July 2007

Certifications

• Certification details not provided.