| Resume alert | Resumes 11 - 20 of 743 |
Formulation/scale up of solid dosage forms
East Brunswick, NJ, 08816
... Supported technology transfer related activities from development to launch for drug products (DPs) at BMS manufacturing sites (or external manufacturing) according to BMS directives, ICH, FDA and regulatory guidelines. Performed physical testing on ... - Apr 03
... Supported technology transfer related activities from development to launch for drug products (DPs) at BMS manufacturing sites (or external manufacturing) according to BMS directives, ICH, FDA and regulatory guidelines. Performed physical testing on ... - Apr 03
Drug Safety Information Technology
Belle Mead, NJ
... • Expert knowledge of Global and FDA Regulations supporting the submission of Adverse Events for Post- marketing and Clinical Trials drugs. • Understanding of ICH guidelines on PV and application of guidelines detailed in FDA 21 CFR Part 11, ... - Mar 29
... • Expert knowledge of Global and FDA Regulations supporting the submission of Adverse Events for Post- marketing and Clinical Trials drugs. • Understanding of ICH guidelines on PV and application of guidelines detailed in FDA 21 CFR Part 11, ... - Mar 29
Business Analyst Change Management
Iselin, NJ, 07067
... Good Automated Manufacturing Practices (GAMP 5) risk-based approach Provided Validation services in achieving the 21 CFR PART 11 (Electronic Records & Signatures) compliance to assure successful data quality and data integrity to, and FDA challenge. ... - Mar 28
... Good Automated Manufacturing Practices (GAMP 5) risk-based approach Provided Validation services in achieving the 21 CFR PART 11 (Electronic Records & Signatures) compliance to assure successful data quality and data integrity to, and FDA challenge. ... - Mar 28
Project Manager Change Management
Bridgewater, NJ
... Developed online Learning Management System (LMS) for certification process training and to meet FDA / compliance requirements. Provided guidance on change management methodology and related communications for stakeholder and user clarity. Ricoh ... - Mar 26
... Developed online Learning Management System (LMS) for certification process training and to meet FDA / compliance requirements. Provided guidance on change management methodology and related communications for stakeholder and user clarity. Ricoh ... - Mar 26
Quality Assurance Project Management
North Brunswick, NJ
... Document Management System), SAP(System Applications products in Data Processing) - Provide all necessary documents to FDA, visitors and auditors by putting uncontrolled copies stamp - To maintain all inventories required for documentation. ... - Mar 17
... Document Management System), SAP(System Applications products in Data Processing) - Provide all necessary documents to FDA, visitors and auditors by putting uncontrolled copies stamp - To maintain all inventories required for documentation. ... - Mar 17
16+ years in Pharmacovigilance. Phase I clinical drug trials as a RN
Edison, NJ, 08817
... Decreased possible late cases through root cause analysis of non-compliant single case reports, circumventing FDA audits and fines, resulting in significant overall savings. Drug Safety Associate Consultant Experience: G & W Laboratories, Inc., ... - Mar 15
... Decreased possible late cases through root cause analysis of non-compliant single case reports, circumventing FDA audits and fines, resulting in significant overall savings. Drug Safety Associate Consultant Experience: G & W Laboratories, Inc., ... - Mar 15
Senior Technical Writer
Morris Plains, NJ
... and foreign RRD regulatory to ensure compliance with FDA, INVIMA, and ANVISA submissions. ·Supported activities to maintain RRD product marketability in U.S. and foreign markets upon CMO change. ·Developed and fostered existing relationships with ... - Mar 15
... and foreign RRD regulatory to ensure compliance with FDA, INVIMA, and ANVISA submissions. ·Supported activities to maintain RRD product marketability in U.S. and foreign markets upon CMO change. ·Developed and fostered existing relationships with ... - Mar 15
Pharmacy Technician Prior Authorization
Warren, NJ
... Khan, MBCS Cell: 201-***-**** Email: ad38vr@r.postjobfree.com Skills US PQC, PTC, FDA, GMID, LMID, GPV, Siebel (ACES), Trackwise, NICE, 21 CFR820, 803, ISO 13485. EUMDR. Veeva Vault, Micro Merchant, Prime Rx, Comet, Pfizer Compliance Education ... - Mar 10
... Khan, MBCS Cell: 201-***-**** Email: ad38vr@r.postjobfree.com Skills US PQC, PTC, FDA, GMID, LMID, GPV, Siebel (ACES), Trackwise, NICE, 21 CFR820, 803, ISO 13485. EUMDR. Veeva Vault, Micro Merchant, Prime Rx, Comet, Pfizer Compliance Education ... - Mar 10
Clinical drug trials, pharmacovigilance, certified in human research
Edison, NJ, 08817
... ●Decreased possible late cases through root cause analysis of non-compliant single case reports, circumventing FDA audits and fines, resulting in significant overall savings. Drug Safety Associate Consultant Experience: G & W Laboratories Inc., ... - Mar 06
... ●Decreased possible late cases through root cause analysis of non-compliant single case reports, circumventing FDA audits and fines, resulting in significant overall savings. Drug Safety Associate Consultant Experience: G & W Laboratories Inc., ... - Mar 06
Patient Care Nurse Coordinator
Clark, NJ, 07066
... WORD/EXCEL ●ONS CERTIFIED ●IND SAFETY REPORTING ●EPIC HYPERSPACE SYSTEM ●FLUENT IN SPANISH ●WIRB/IRB SAFETY REPORTING ●FDA EXPERIENCE WITH MULTIPLE SUCCESSFUL AUDITS ●CCRP ●CONFERENCE ATTENDANCE, INCLUDING ASH TRIALS PARTICIPATED IN THAT LEAD ... - Mar 03
... WORD/EXCEL ●ONS CERTIFIED ●IND SAFETY REPORTING ●EPIC HYPERSPACE SYSTEM ●FLUENT IN SPANISH ●WIRB/IRB SAFETY REPORTING ●FDA EXPERIENCE WITH MULTIPLE SUCCESSFUL AUDITS ●CCRP ●CONFERENCE ATTENDANCE, INCLUDING ASH TRIALS PARTICIPATED IN THAT LEAD ... - Mar 03