Profile Details

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USD 210 /hr

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☆☆☆☆☆

Hire Dr. Evita A.

United States

USD 210 /hr

Medical Writer/Regulatory Affairs/Project Manager

Profile Summary

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

Subject Matter Expertise

• ★ 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

Services

• 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

Work Experience

Senior Medical Writer

Medpoint LLC

July 2019 - Present

Journal Article Editor

Archives of Environmental and Occupational Health

November 2012 - Present

Healthcare and Medical Communications Consultant

Freelance

February 2012 - Present

Medical Writer

R&Q Solutions

December 2018 - June 2019

Education

Medical Doctor, M.D.

AUA College of Meficine

January 2017 - Present

Masters degree in Biomedical Science

University of Medicine and Dentistry of New JerseY

August 2011 - October 2012

Masters degree in Public Health

University of Arkansas for Medical Sciences

August 2004 - December 2006

Certifications

• Certification details not provided.