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Resume alert |
Resumes 21 - 30 of 542 |
Philadelphia, PA
... provided Quality oversight of internal and external clinical trial activities, related records, and processes to assure management in accordance with FDA regulations, ICH-GCP, SOPs and all other applicable regulations and assisted with other tasks ...
- Feb 26
Havertown, PA
... ability to talk with individuals at all levels • Very knowledgeable with CRO, Clinical trial processes, HIPAA and other myriad FDA regulations and compliances Professional Experience Diagnostic Solutions Laboratory 2013-2022 Director, New Business ...
- Feb 22
Pennsauken, NJ
... lung, and gastric cancers across 15 sites in the United States from start-up activities including feasibility, final protocol, FDA follow-up, study and site contracts and budgets, master ICF development and approval, oversight of site ICF ...
- Feb 18
Philadelphia, PA
... Key Achievements: • Secured FDA approval for five items within a 24-month timeframe. • Introduced high-speed, needle-free injection systems at US military bases. • Positioned the company as a frontrunner in global health endeavors targeting ...
- Feb 11
Philadelphia, PA
... Knowledge of FDA and HIPPA regulations, medical terminology, laboratory testing procedures and equipment. Familiar with GLP and GCP environment. A highly motivated person with strong analytical and organizational skills. A dedicated team player also ...
- Feb 06
Philadelphia, PA
... Comply to all SOP, cGMP, SAP, AND FDA standards. October 2004- March 2018 Animas Corporation of Johnson & Johnson West Chester, PA Served in several employment capacities and have demonstrated Johnson & Johnson Credo values while fulfilling numerous ...
- Feb 05
East Norriton, PA
... Analyst Practice TheraCom, Rockville, MD (client engagement) May 2009 to August 2009 Engaged to perform a Gap Analysis of the current situation within the Software Development Group and define what is needed to create FDA approved software systems. ...
- Jan 27
Hockessin, DE
... Subject matter expert (SME), oncology, hematology, cardio-metabolic disease, reproductive care, and genetics in communications with the Food and Drug Administration (FDA) and Advisory Board. Used knowledge in CART-T Cell immunotherapy, stem cell ...
- Jan 23
Ambler, PA
... Scientist/Group Leader 12/2003 to 12/2008 Par Pharmaceutical Companies, Inc (Kali Labs) Spring Valley, NY Executed CMC section for ANDA projects from initial stage of development to final FDA approval with one direct report and two to three on an ...
- Jan 21
Chalfont, PA
... Management, Validation and FDA Compliance, Leading High Performance Teams, CTFA Cleaning/Sanitizing validation, P&G Auditor training, cGMP seminar, PMI (project management Institute) and Lean manufacturing seminars, 6 Sigma, Veeva Vault seminars. ...
- Jan 19