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Jeanine Avery | Elance
 
176985602337900
Last Sign-in: Jun 26, 2015

Jeanine Avery

Regulatory Affairs/CMC Specialist 10+ Yrs GMP/Mfg
   United States
  |   Philadelphia, PA

Overview

Minimum Hourly Rate $44

I have a Bachelorís degree in Biology and more than 12 years of experience in the Pharmaceutical/Biotech industry. I have a number of years of experience in regulatory, compliance and industry regulations including GMP, GLP and GCP. I have more than 8 years of experience writing, reviewing, and editing regulated documents including, but not limited to SOPs, preclinical study reports, and regulatory submissions.
More specifically, my five years of regulatory experience includes project management, preparing and reviewing various types of...

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Skills (10)

Tested
GMP
CMC
CTD
Dossier
FDA
ICH
EMEA
Regulatory Affairs
SOP
CFR

Service Description

I am an efficient, detail-oriented pharmaceutical professional that maintains a working knowledge of industry regulations, remains task and goal oriented and can adapt well to various settings as I have a very inclusive background.

I can provide CMC section writing and reviews as well as general regulatory services. I offer quality control and quality assurance expertise with regards to pharmaceutical manufacturing and biotechnology. Additionally I can provided SOP writing and revising as well as training services.

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Overview  |  Job History  |  Resume/C.V.

Keywords

CMC CGMP GMP Regulatory Affairs CTD ICH EMEA FDA Dossier Regulations MHRA SOP Manufacturing CAPA troubleshooting Quality Assurance Quality Control Documentation Documentum Guidelines CFR
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Innovative78
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Jeanine Avery | Elance

Jeanine Avery