プロフィール詳細

プロジェクトを作成

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Sherri H.に依頼

United States

Clinical Quality Assurance Consultant with 20+ years experience with FDA, EMA and other regulators including Clinic

プロフィール概要

A QA expert with 20 + years of experience working for small and large pharma/biotech/medical device, IRB organizations and FDA, providing expertise include Sponsor Oversight & Vendor Management, Clinical Development Support, study plans, QMS & SOP Architecture, Regulatory Readiness and Risk Management to ensure inspection readiness.

専門分野

• ★ Clinical Trials
• ★ Gap Analysis
• ★ Instructional Webinars
• ☆ Drug Development
• ☆ Small Molecule Drug Development
• ☆ IRB Applications
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Gene Therapy
• ☆ Peer Review
• ☆ Continuing Medical Education (CME) Training
• ☆ Skills Training
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ SOP & Protocol Writing
• ☆ White Papers

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation

Research Fact Checking, Gap Analysis

Consulting Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Quality Assurance & Control (QA/QC)

職務経験

Director, Clinical Quality Assurance

Vera Therapeutics

5月 2024 - 3月 2026

Senior Director, GCP Quality Assurance

Eiger Biopharmaceuticals

12月 2021 - 3月 2024

Senior Director, GCP Quality Assurance

Myovant Sciences

5月 2021 - 9月 2021

Director, Vendor Compliance

Gilead Sciences

1月 2019 - 1月 2021

Senior Director, U.S., QA, Risk & Compliance

Premier Research

5月 2008 - 6月 2018

Program Manager (equivalent to IRB Administrator)

IRB & Human Research Mgt (formerly RCRC IRB owned by PPD)

10月 2006 - 5月 2008

Associate Director, Clinical Quality Assurance

PPD

9月 1998 - 10月 2006

Consumer Safety Officer

US FDA

12月 1989 - 9月 1998

学歴

Bachelor of Science

Texas Woman's University - United States

5月 1978 - 5月 1980

認定資格

• 認定資格の詳細は未入力です。