Profile Details

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USD 70 /hr

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Hire Selina B.

United States

USD 70 /hr

Experienced medical writer

Profile Summary

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

Subject Matter Expertise

• ★ 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

Services

• 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

Work Experience

Senior Medical Writer

Terumo Medical Corporation

June 2021 - Present

Consultant

Medpoint, LLC

June 2019 - Present

Education

Doctorate of Medicine (MD)

American Universtiy of Antigua, College of Medicine

January 2017 - Present

Bachelors of Arts

Shepherd University

January 2015 - Present

Certifications

• Certification details not provided.