Anne Kulak
Trial Master File Operations and Inspection Readiness
- Role
- Inspection Readiness Lead at kps life
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
Experience
Inspection Readiness Lead
Oct 2022 — Present
Education
Pennsylvania State University
Bachelor of Social Science (BSS)
University of Pennsylvania
Master of Liberal Arts (MLA)
Drexel University
Master of Library & Information Science (MLIS)
Skills
- Clinical Trials
- Pharmaceutical Industry
- Clinical Development
- Gcp
- U.s. Food and Drug Administration (Fda)
- Cross-Functional Team Leadership
- Regulatory Affairs
- Business Process Improvement
- 21 Cfr Part 11
- Data Management
- Biotechnology
- Project Management
- Fda
- Ctms
- Competitive Intelligence
- Document Management
- Regulatory Submissions
- Business Analysis
- CRO
- Process Improvement
- Sop
- Oncology
- Gxp
- Business Analytics
- Lifesciences
- Software Documentation
- Clinical Data Management
- Validation
- Pharmacovigilance
- Edc
- Quality Assurance
- Computer System Validation
- Product Marketing
- Life Sciences
- Marketing Strategy
- Strategic Planning
- Regulatory Requirements
- Standard Operating Procedure (Sop)
- CRO Management
- Management
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