Sr. Director, QMS Process Management and Optimization @ (July 2020 - February 2024)
Director, Controlled Procedural Documents (Quality Assurance and Compliance) @ (April 2019 - July 2020)
Associate Director, Regulatory Policy, Compliance and Standards @ (May 2015 - July 2020)
Sr. Manager, RDCM @ (March 2013 - December 2014)
Manager, Project Planning @ Kyowa Hakko Kirin Pharma Inc (April 2011 - February 2013)
Director, Document Managment and Trial Registration @ (February 2006 - August 2010)
Associate Director, Medical Program Documentation Specialist (MPDS) and Manager, MPDS @ (January 2002 - January 2006)
Clinical Associate and Sr. Medical Program Coordinator and Medical Program Coordinator @ (January 1991 - January 2002)
Medical Research Associate @ (January 1989 - January 1991)
Clinical Research Associate @ (January 1984 - January 1989)
Donna Walters Education
University of Delaware
Bachelor of Arts - BA (Biology, General)
Donna Walters Skills
Ortho
Document Management
Oversight
Integration
Integration Projects
Clinical Trials
Informed Consent
Oncology
Strategy
IRB
Good Clinical Practice Gcp
Delaware
Women in Business
Protocol
Relationship Management
Regulations
Clinical Trial Management System Ctms
Consolidation
Consent
Opx2
House
Net
Savings
Design
Assertiveness
Home
Metrics
Records Management
Financial Forecasting
Project Planning
Training
Medical Research
Management
International Sales
Databases
Compliance
Patient
Initiation
Programming
Internal Medicine
Committees
Switch
Documentation
Visio
Staff Supervision
IT Solutions
Execution
System
Documentum
Protocol Writing
Gastroenterology
Safe Harbor
Contract Negotiation
Quality Assurance
Procurement
Project
FIX Protocol
Change Management
Pharmaceutical Industry
Third Party Applications
Community
Monitors
Auditing
Team Management
Operational Planning
Start Ups
Training/Mentoring
Clinical Development
Clinical Operations
Pregnancy
Healthcare
Wood
Government Liason
Sop
Sae
Selections
Research
Template Development
Form Development
Metabolism
Leadership
Delivery
Cross Functional Team Leadership
Process Improvement
Vendors
Capacity Planning
Repository
Drug Product
ERP
Belt
Data Systems
Queries
Temporary Placement
Contractors
Partnerships
Planning
IV
Operations
CRO Management
Means
Marketing
Pain Management
Regulatory Submissions
Biology
Microsoft Office
Efficient
Data Management
Publications
Pharmaceutical Research
Drug Development
Business Process Re Engineering
Multiple Therapeutic Areas
Algorithms
Immunology
R
Data Collection
Document Processing
Reorganisation
Six Sigma
Coordination
Performance Management
Medical Monitoring
Special Interest
OTC
Endocrinology
Internal Audit
Therapeutic Areas
Mega
Biotechnology
Finalist
Data Review
Responsibility
Allergy
CRO
Report Writing
Program Management
Contract Management
Dia
Safety
Orthopedics
Microsoft Project
Cardiology
Ama
Diabetes
Clinical Research
Bourne
Medical Records
Internal Staff
Reporting
Dermatology
Query Writing
Asthma
Problem Solving
Asset Allocation
Source
Negotiation
Solution
Budgets
Life Sciences
American
u.s. Food and Drug Administration Fda
Computer Proficiency
Guidelines
Cost Effective
Osteoporosis
Writing
Program Development
FDA
Overseeing
Medicine
Trials
Treatment
Data Monitoring
GCP
Wma
Project Management
Surgery
Efficacy
Gateway
Encoding
New Hires
CTMS
Clinical Trial Management System
Good Clinical Practice
u.s. Food and Drug Administration
Donna Walters Summary
Donna Walters, based in New York, NY, US, is currently a Sr. Director, Clinical Quality Assurance at Kardigan. Donna Walters brings experience from previous roles at Kardigan, Bristol Myers Squibb and Covance. Donna Walters holds a Bachelor of Arts - BA in Biology, General @ University of Delaware. With a robust skill set that includes Ortho, Document Management, Oversight, Integration, Integration Projects and more. Donna Walters has 1 emails and 2 mobile phone numbers on RocketReach.
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