プロフィール詳細

プロジェクトを作成

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Selina B.に依頼

United States

Experienced medical writer

プロフィール概要

Medical Communications Consultant -Writing Clinical Evaluation Reports (CER) for medical device manufacturers -Preparation of clinical reports or other regulatory documents supporting ongoing clinical development programs - FDA Quality Systems and Reporting - Class IIa, IIb, and III device - MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices

専門分野

• ★ Medical Device Regulatory Writing
• ★ Clinical Evaluation Reports (CER)
• ☆ Evaluation Methodology
• ☆ Drug Development
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Medical Sciences
• ☆ Research Methodology
• ☆ Medical Writing
• ☆ Technical & Scientific Writing
• ☆ Management Consulting

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Copywriting, Newswriting, General Proofreading & Editing

Research User Research, Meta-Research, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Product Evaluation, Product Compliance

職務経験

Senior Medical Writer

Terumo Medical Corporation

6月 2021 - 現在

Consultant

Medpoint, LLC

6月 2019 - 現在

学歴

Doctorate of Medicine (MD)

American Universtiy of Antigua, College of Medicine

1月 2017 - 現在

Bachelors of Arts

Shepherd University

1月 2015 - 現在

認定資格

• 認定資格の詳細は未入力です。