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Wilmington, DE, 19806
... Expertise includes: Credit and Finance Customer Service Support Key Relationship Development Emerging Pharmaceutical R&D Support Sales and Marketing Financial Statement Analysis GAAP Knowledge Analytical Portfolio Management FDA And DEA Records ...
- Aug 29
Philadelphia, PA
... Management (Agile & Waterfall) UDI Compliance & Global Data Integration (GDSN, GS1, HIBC) Regulatory Affairs Support (FDA, EU MDR, ROW) Labeling Lifecycle Management (PLM, SAP, Adobe) Cross-functional Team Leadership Risk & Change Management ...
- Aug 21
Philadelphia, PA
... • • Ensured that all products meet FDA and GMP regulations prior to release into the market. • Monitored the performance of automated equipment in a GMP environment. Provided training on GMP, ISO 9000, and other relevant regulatory guidelines to ...
- Aug 18
Lansdowne, PA
... Suite and Board of Directors at Thomas Jefferson Health System and secured $2M contract for groundbreaking product prior to FDA approval Presented information to 60 prospects about an innovative product not yet covered by insurance, the first multi ...
- Aug 06
Philadelphia, PA
... Experienced in launching an oncology ‘FDA breakthrough status’ indication under priority review timelines. Strong relationships with GPOs, IDNs, key oncology accounts, payers, PBMs academic centers, and national professional organizations. Direct ...
- Aug 06
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 ...
- Aug 04
Delaware County, PA
... existing business processes to support the actualization of data standards for the Identification of Medicinal Products (IDMP) and Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC), as required by the regulatory bodies (FDA & EMA). ...
- Aug 04
Phoenixville, PA
... oSarbanes-Oxley (SOX) oSystem and Organization Controls (SOC 1, SOC 2) oTesting, Evidence, Work Papers Preparation for External Auditors (KPMG, PwC, E&Y, Deloitte) oDatacenters Construction, Migration, Setup and Coordination USDA, RMA, FDA, FAA, SEC ...
- Aug 02
Doylestown, PA
... Helped design many protocols, experiments, and FDA immunoassay submission packages. Other Work Experience Adjunct Instructor in Business, Economics, and Finance at Delaware Valley University, Doylestown, PA (2020-present), Gwynedd-Mercy University, ...
- Jul 31
Bensalem, PA
... •Identified and escalated adverse events in line with FDA guidelines, ensuring regulatory compliance. •Analyzed customer portal data to identify and address missing information, leading to improved customer satisfaction. •Created work instructions ...
- Jul 21