プロフィール詳細

プロジェクトを作成

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Peggy G.に依頼

United States

Senior Medical Writer at Medtronic

プロフィール概要

Having over 20-years’ experience working in nursing and public health research, I turned my focus to medical writing almost a decade ago. I have been working as a medical writer in a variety of capacities, although the past several years have been focused solely on writing Clinical Evaluation Reports (CERs) on the safety and performance of medical devices for the regulatory bodies for compliance with the European Union standards. I have written clinical evaluation reports on many different Class III implantable devices in several therapeutic areas, primarily orthopedics, spine and trauma, faciomaxillary, cardiac rhythm therapies such as pacemakers and implantable defibrillators, etc., and neurology for indications including hydrocephalus, aneurysms as well as neuromodulation. These reports are quite comprehensive and represent safety and precaution evaluations on a device, to become an integral component of the manufacturer device portfolio. I am very excited about my work as in writing these reports I am able to use my skills as a writer in many different areas: systematic literature surveys, epidemiological reporting, post-market surveillance analyses, and state-of-the-art assessments, safety analyses, to name a few. I believe my background is comprehensive, addressing medical communications, clinical and academic research, and publication protocol.

専門分野

• ★ Medical Device Regulatory Writing
• ★ Clinical Evaluation Reports (CER)
• ★ Systematic Literature Review
• ☆ Surveillance Systems
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Implants
• ☆ Medical Device Regulatory Consulting
• ☆ Pacemakers
• ☆ Public Health
• ☆ Cardiac Nursing
• ☆ Product Compliance
• ☆ Literature Search
• ☆ Medical Writing
• ☆ SEO Medical Writing
• ☆ European Law

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Regulatory Consulting

Data & AI Statistical Analysis, Data Processing

職務経験

Senior Medical Writer

Philips Healthcare

8月 2019 - 現在

Principle CER Medical Writer

Zimmer Biomet

3月 2018 - 11月 2018

Principle Medical Writer

Saint Jude Medical/Abbott

9月 2017 - 4月 2018

Research Consultant

Johnson & Johnson

12月 2015 - 4月 2017

学歴

Medical and Scientific Writing

University of California at San Diego

1月 2017 - 現在

認定資格

• 認定資格の詳細は未入力です。