Wilesha Wright
Associate Director of Regulatory Operations at MacroGenics at MacroGenics, Inc.- Claim this Profile
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Bio
Credentials
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Lean Sigma Practitioner
IQVIA -
Lean Sigma Practitioner
IQVIA -
RIM Smart - Train the Trainer
IQVIA
Experience
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MacroGenics, Inc.
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United States
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Biotechnology Research
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200 - 300 Employee
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Associate Director of Regulatory Operations at MacroGenics
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May 2022 - Present
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Senior Regulatory Operations Manager
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Feb 2022 - May 2022
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PPD
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United States
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Research Services
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700 & Above Employee
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Regulatory Affairs Manager
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Mar 2021 - Feb 2022
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IQVIA
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United States
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Hospitals and Health Care
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700 & Above Employee
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Regulatory Affairs Officer 2 - Submission Publishing
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Jan 2021 - Mar 2021
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Regulatory Affairs Officer 1 – Submission Publishing
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Oct 2016 - Dec 2020
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Operations Specialist
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May 2015 - Oct 2016
Lifecycle Safety Operations Specialist review, assess and process Lifecycle Safety data and information, across all service lines received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations standard operating procedures and internal guidelines
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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CMC PPS Submission Specialist
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Oct 2010 - May 2015
Responsible for the provision of authoring support to Global Regulatory Executives ensuring full publishing support of regulatory submissions in accordance with GSK’s Global Submission Writing Process.
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Regulatory Affairs Assistant
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Aug 2007 - Oct 2010
Provided support to senior regulatory affairs professionals for the preparation, compilation and submission of post‐approval regulatory filings related to one or more therapeutic areas.
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Education
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1997 - 2001
Converse College
Bachelor of Arts (BA), English/Language Arts Teacher Education
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