プロフィール詳細

プロジェクトを作成

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Dr. Evita A.に依頼

United States

Medical Writer/Regulatory Affairs/Project Manager

プロフィール概要

A clinical research scientific writer with clinical medical, CSR. and regulatory CER expertise in MEDDEV 2.7/1 rev4 documentation, EU MDR and FDA compliance. Provided strategic support in regulatory affairs, post-market product surveillance, and quality assurance in CE marking of EU Class I, IIa, IIb or III medical devices by writing Clinical Evaluation Reports (CERs) providing clinical evidence of the device's state of the art for medical treatment and its safety and performance. Experience in development of clinical trials (Ph. I – IV) documents and corresponding submissions and preparation of clinical study reports or other regulatory documents supporting ongoing clinical development programs. Narrative/systematic literature reviews: Cochrane, PubMed, Embase, Medline Ovid, DistillerSR (e.g. PRISMA), Google Scholar; Excellent technical skills: peer-reviewed scientific publications, scientific presentations, and university-level teaching

専門分野

• ★ European Medical Device Regulation (MDR)
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Medical Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Newswriting

Research Market Research, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis, Data Visualization

Product Development Formulation

職務経験

Senior Medical Writer

Medpoint LLC

7月 2019 - 現在

Journal Article Editor

Archives of Environmental and Occupational Health

11月 2012 - 現在

Healthcare and Medical Communications Consultant

Freelance

2月 2012 - 現在

Medical Writer

R&Q Solutions

12月 2018 - 6月 2019

学歴

Medical Doctor, M.D.

AUA College of Meficine

1月 2017 - 現在

Masters degree in Biomedical Science

University of Medicine and Dentistry of New JerseY

8月 2011 - 10月 2012

Masters degree in Public Health

University of Arkansas for Medical Sciences

8月 2004 - 12月 2006

認定資格

• 認定資格の詳細は未入力です。