Carol E Gerhart is a high-level expert, working in Beigene main office of which is in 518. on the position of Manager, Regulatory Technology since 2020. This person has earned professional experience in more than 13 positions at different companies. Carol E Gerhart went to the Rutgers University and got education there. Los Angeles, California is the city, where this expert was lastly known to settle. This professional's e-mail and phone are easily accessed through this website by request.
Name variants:
Carrol Gerhart,
Carroll Gerhart,
Carole Gerhart,
Karol Gerhart,
Carrie Gerhart,
Carry Gerhart
Last updated Jul 05, 2024
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Work History
Manager, Regulatory Technology
55 Cambridge Pkwy SUITE 700W, Cambridge, MA 02142
from Jun 2020
Lead Submission Management, Global Regulatory Affairs Operations
At Shire, our purpose of enabling people with life-altering conditions to lead better lives is at the center of everything we do. We're continuously looking for opportunities to strengthen o...
Jun 2016 — Dec 2017
Mgr, Reg Affairs
Illinois
Baxter split off Bioscience business as Baxalta, a separate company, as of May 2015 In addition to all previous responsibilities as described for Baxter, also managed the following:
Submit...
May 2015 — Jun 2016
Mgr, Reg Affairs
1 Baxter Pkwy, Deerfield, IL 60015
Function as the interface to the Regulatory Affairs Leads: R&D and CMC Manage all submission publishing [paper, eBLA & eCTD for all phase of the regulatory process for submissions to the US...
Nov 2013 — May 2015
Senior Business Analyst
222 north Pacific Coast Hwy, El Segundo, CA
Apr 2013 — Nov 2013
Computer Validation Quality Assurance, Computer Software Lifecycle Management
Software quality assurance for regulated systems (GxP), full computer system lifecycle management from vision statements, business process mapping, enabling technology system specifications ...
Sep 2012 — Mar 2013
Manager, Quality Management and Integration Testing
2000 Galloping Hill Rd, Kenilworth, NJ 07033
1998 — 2005
Senior Systems Associate
2000 Galloping Hill Rd, Kenilworth, NJ 07033
Developed and implemented the plan for the Clinical & Regulatory Information Strategic Program (CRISP). This effort was initiated to address the lack of an IS organizational structure to sup...
1996 — 1998
Systems Associate and Senior Systems Analyst
2000 Galloping Hill Rd, Kenilworth, NJ 07033
Led Quality Assurance activities for the ZOCOR Clinical Data Collector Build Team: Managed process improvement and QA for collector development and deployment for Production Services. Outcom...
1993 — 1996
Senior Data Coordinator, Animal Health
2000 Galloping Hill Rd, Kenilworth, NJ 07033
System Manager/Project Manager for Animal Health Research & Development's (AHARD) computer systems worldwide. - Participated in the selection and led the implementation of a VAX / All-In-One...
1988 — 1993
Programmer and Analyst
2000 Galloping Hill Rd, Kenilworth, NJ 07033
Developed and implemented computer systems for the analysis of research data for basic research scientist.
1987 — 1988
Clinical Data Coordinator
Reviewed and encoded clinical drug trial Case Report Form (CRF) information for client studies
Managed data discrepancy resolution and all database updates
Designed and programmed SAS edi...
1986 — 1987
Occupations
Executive
Manager
Scientist
Biotechnology Professional
Artist
Model
Operations Manager
Biologist
Biological Scientist
Skills
Computer System Validation
Software Quality Assurance
Software Engineering
21 Cfr Part 11
Project Management
Business Analysis
System Integration Testing
Certified 6 Sigma Greenbelt
Business Process Re Engineering
Vendor Management
Agile Methodologies
Computer Validation Quality Assurance
Rup Methodologies
Team Facilitation
Requirements Management
Sharepoint
Nintex
Business Process Development
Business Process Mapping
Business Process Design
Business Process Testing
Software Development Life Cycle
Lean 6 Sigma
Microsoft Office
Software Configuration Management
Itil
Code Review
Visio
T Sql
Ms Project
Document Management
Microsoft Sql Server
Six Sigma
Validation
Gxp
Pharmaceutical Industry
Testing
Fda
U.s. Food and Drug Administration
Software Development Life Cycle