プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

Ramamurthy J.に依頼

India

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

プロフィール概要

▪ 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

専門分野

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

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Technical Writing

Research Market Research, Meta-Research, Systematic Literature Review

Consulting Regulatory Consulting

Data & AI Data Processing

職務経験

Specialist Medical Writing

Actalent

7月 2021 - 現在

学歴

M.Sc Biochemistry

Annamalai University

6月 2005 - 7月 2007

認定資格

• 認定資格の詳細は未入力です。