| Resume alert | Resumes 41 - 50 of 591 |
Synthetic Organic Continuous Improvement
Willingboro, NJ
... Patents and a robust consultancy background managing IND-Enabling Studies and drug supply, CMC management (Phase 1-2a), and recognized expert Credited with discovering DPP4 inhibitor saxagliptin (Onglyza) at BMS for T2DM, FDA 2009 and credited with ... - 2023 Dec 18
... Patents and a robust consultancy background managing IND-Enabling Studies and drug supply, CMC management (Phase 1-2a), and recognized expert Credited with discovering DPP4 inhibitor saxagliptin (Onglyza) at BMS for T2DM, FDA 2009 and credited with ... - 2023 Dec 18
Software Program Management Strategy
Lansdale, PA
... Piramal Pharmaceuticals (Teva supplier) - Pennsylvania QAIT Architect 07-2022 to 02-2023 In less than six months, I built a new, highly efficient risk-based CSV program in preparation for an FDA audit and product release. I Developed twenty-seven ... - 2023 Dec 18
... Piramal Pharmaceuticals (Teva supplier) - Pennsylvania QAIT Architect 07-2022 to 02-2023 In less than six months, I built a new, highly efficient risk-based CSV program in preparation for an FDA audit and product release. I Developed twenty-seven ... - 2023 Dec 18
Production Supervisor Plant Manager
Wilmington, DE
... (The above job was a transfer still within DuPont) OTHER EXPERIENCE: FDA, CGMP, Six Sigma, Safety Committee, SAP, JD Edwards, Certified in Tech Drafting, Certified in First Aid and CPR, ISO Audit Training, Implemented TMS, CMM Training. TOOL AND ... - 2023 Dec 15
... (The above job was a transfer still within DuPont) OTHER EXPERIENCE: FDA, CGMP, Six Sigma, Safety Committee, SAP, JD Edwards, Certified in Tech Drafting, Certified in First Aid and CPR, ISO Audit Training, Implemented TMS, CMM Training. TOOL AND ... - 2023 Dec 15
Quality Management System
Cherry Hill, NJ
... Documented product complaints into Quality Management Systems database for trending and responsible for investigating, completing, and maintaining Complaint Records in timely and accurate manner in accordance with the FDA's QSR Regulations, ISO ... - 2023 Dec 11
... Documented product complaints into Quality Management Systems database for trending and responsible for investigating, completing, and maintaining Complaint Records in timely and accurate manner in accordance with the FDA's QSR Regulations, ISO ... - 2023 Dec 11
Administrative
Wilmington, DE
... 01/2014 – 03/2014 Cura Scripts/Express Scripts, New Castle, DE Administrative Assistant (temporary assignment) Input prescription numbers into RX Home System, print out prescription & label and attach for FDA auditing purposes, filing, and train new ... - 2023 Dec 10
... 01/2014 – 03/2014 Cura Scripts/Express Scripts, New Castle, DE Administrative Assistant (temporary assignment) Input prescription numbers into RX Home System, print out prescription & label and attach for FDA auditing purposes, filing, and train new ... - 2023 Dec 10
Medical Device Surgical
Swedesboro, NJ
... Advance knowledge in FDA, EMA and PMDA regulatory compliance. Well versed in 21 CFR Part 803. Proficient in global GMP and Regulatory requirements. Working knowledge in CAPAs, INDs, recalls, QA, JDE, Literature, legal (litigations), clinical trials ... - 2023 Dec 08
... Advance knowledge in FDA, EMA and PMDA regulatory compliance. Well versed in 21 CFR Part 803. Proficient in global GMP and Regulatory requirements. Working knowledge in CAPAs, INDs, recalls, QA, JDE, Literature, legal (litigations), clinical trials ... - 2023 Dec 08
Project Management Sas Programmer
Norristown, PA
... Assisted with FDA submissions of ISE and ISS with extensive graphs, tables, and listings. Led validation of TLF and analysis data . Worked in therapeutic areas of oncology, cardiovascular, diabetics studies, and blood pressure reductions. AUXILIUM ... - 2023 Dec 06
... Assisted with FDA submissions of ISE and ISS with extensive graphs, tables, and listings. Led validation of TLF and analysis data . Worked in therapeutic areas of oncology, cardiovascular, diabetics studies, and blood pressure reductions. AUXILIUM ... - 2023 Dec 06
Registered Pharmacist and Immunizer BCGP, PA, NJ, DE, VA
Philadelphia, PA
... Responsibility for clinical and operational compliance with USP 797, FDA, DEA, and PA BoP regulations Performed benefit appeals or other reimbursement/payer research, responded to CMS and PBM audits Took reports of and responded to: Assisted ... - 2023 Dec 05
... Responsibility for clinical and operational compliance with USP 797, FDA, DEA, and PA BoP regulations Performed benefit appeals or other reimbursement/payer research, responded to CMS and PBM audits Took reports of and responded to: Assisted ... - 2023 Dec 05
Regulatory Affairs United States
Mount Laurel, NJ, 08054
Lamont Michael Fulton Regulatory Affairs Consultant Former FDA Reviewer and Policy Analyst Reviewed hundreds of Drug Applications submitted to the FDA for market approval in the United States. Served as adviser to the Office of Regulatory Affairs to ... - 2023 Nov 29
Lamont Michael Fulton Regulatory Affairs Consultant Former FDA Reviewer and Policy Analyst Reviewed hundreds of Drug Applications submitted to the FDA for market approval in the United States. Served as adviser to the Office of Regulatory Affairs to ... - 2023 Nov 29
Project Management Software Development
Collegeville, PA
... Reviewed clinical processes and FDA compliance records. Scheduled document production coordinated outside counsel on both corporations and collected technical and commercial data. Managed all communications with Analysts and all vendors and clients ... - 2023 Nov 20
... Reviewed clinical processes and FDA compliance records. Scheduled document production coordinated outside counsel on both corporations and collected technical and commercial data. Managed all communications with Analysts and all vendors and clients ... - 2023 Nov 20