Mona Abdel
Director at Ascentage Pharma
Based in New York, United States
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Seniority
Director
Department
General Business & Management
Location
New York
Industry
Biotechnology Research
Company size
169
Contact information
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m•••••••@ascentage.cn
Phone
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Background
About Mona Abdel
Knowledge of the drug development process, US FDA Regulations, INDs, NDAs and ICH Good Clinical Practice Guidelines. Detailed practical knowledge of test procedures in FDA regulated environments, GxP, 21 CFR Part 11 regulations, Software Development Life Cycle Management and working knowledge of Documentum. Understands and applies the Drug Regulatory terminology and purpose, including informed consent process, IRB, Investigator and Sponsor responsibilities. QA/Validation/Test Lead experience working in the pharmaceutical/ healthcare industry. Effective communication and presentation skills to manage project and provide training to project team members. Leadership skills, strong work ethic and focus on flexibility, ability to multi-task, attention to detail, excellent interpersonal and organizational skills, good follow up and judgment, and able to prioritize.
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