| Resume alert | Resumes 41 - 50 of 710 |
Senior Director Quality Control
Piscataway, NJ
... all processes and documents for digital FDA review remotely. •Developed company expansion capacity models and execute resourcing strategies to ensure delivery of activities and scopes of work from various internal teams and external consultants ... - Jan 02
... all processes and documents for digital FDA review remotely. •Developed company expansion capacity models and execute resourcing strategies to ensure delivery of activities and scopes of work from various internal teams and external consultants ... - Jan 02
Vice President Executive Director
Trenton, NJ
... Assisted in the preparation of FDA filing for Vanlev preparing articles and references to meet the FDA standards. TAS Coordinator for time allocation for the exempt employees. *Responsible for overseeing administrative staff of eight (8); ... - Jan 02
... Assisted in the preparation of FDA filing for Vanlev preparing articles and references to meet the FDA standards. TAS Coordinator for time allocation for the exempt employees. *Responsible for overseeing administrative staff of eight (8); ... - Jan 02
Statistical Programmer Customer Service
Edison, NJ
... • Provided further analysis as requested by FDA after submission. Carried out new analyses on past studies and designed tables to display information. • • Produced patient profiles listings for oncology studies. Created standard and custom reports ... - Jan 02
... • Provided further analysis as requested by FDA after submission. Carried out new analyses on past studies and designed tables to display information. • • Produced patient profiles listings for oncology studies. Created standard and custom reports ... - Jan 02
Drug Safety Team Leader
North Brunswick, NJ, 08902
... Proficient in performing causality assessment, writing case summaries and assisting in preparing reports for FDA, EMA and EU submissions. High-energy result-driven dedicated, team player, multi-tasking experienced professional with strong ... - 2023 Dec 22
... Proficient in performing causality assessment, writing case summaries and assisting in preparing reports for FDA, EMA and EU submissions. High-energy result-driven dedicated, team player, multi-tasking experienced professional with strong ... - 2023 Dec 22
Low Voltage Industrial Maintenance
Edison, NJ
... I understand the rigors of not only performing a task/project correctly but also documenting work in a fashion that is clear and concise since it is subject to FDA inspections. Realize the critical importance of developing relationships both inside ... - 2023 Dec 20
... I understand the rigors of not only performing a task/project correctly but also documenting work in a fashion that is clear and concise since it is subject to FDA inspections. Realize the critical importance of developing relationships both inside ... - 2023 Dec 20
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
Inside Sales Representative
Middlesex County, NJ
... Awards 2016 “Client Service Excellence Award” 2006, 2008, 2010 “Together with Purpose Award-Inside Sales” Top producer inside sales 8 straight years Created policy reducing quality assurance margin of error from 10% to 3% improving FDA requirement ... - 2023 Dec 15
... Awards 2016 “Client Service Excellence Award” 2006, 2008, 2010 “Together with Purpose Award-Inside Sales” Top producer inside sales 8 straight years Created policy reducing quality assurance margin of error from 10% to 3% improving FDA requirement ... - 2023 Dec 15
Quality Assurance Control
Princeton, NJ, 08540
... Share point, LMS, MES PAS/X, Veeva Vault CDOCs, eDMS/EDC, Maximo, Microsoft office, Adobe Acrobat and DocuSign Knowledge of FDA regulations, 21 CFR 210 & 211, ICH guidelines, 21 CFR Part 11, ISO 9001, eTMF (electronic Trail Master File), eCRF, ... - 2023 Dec 14
... Share point, LMS, MES PAS/X, Veeva Vault CDOCs, eDMS/EDC, Maximo, Microsoft office, Adobe Acrobat and DocuSign Knowledge of FDA regulations, 21 CFR 210 & 211, ICH guidelines, 21 CFR Part 11, ISO 9001, eTMF (electronic Trail Master File), eCRF, ... - 2023 Dec 14
Quality Assurance Control
Trenton, NJ
... Verify the certificate of analysis and FDA documents for imported materials. Approve or reject the incoming candies and packaging material in M3 system. To supervise packaging room to assure packaging is done according to SOP. Perform metal detector ... - 2023 Dec 11
... Verify the certificate of analysis and FDA documents for imported materials. Approve or reject the incoming candies and packaging material in M3 system. To supervise packaging room to assure packaging is done according to SOP. Perform metal detector ... - 2023 Dec 11
Human Resources Manager
Middlesex, NJ
... and guidelines under the Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), Federal Drug Administration (FDA) and International Conference on Harmonization (ICH) Suggest recommendations for changes to contracts, budgets, rental ... - 2023 Dec 08
... and guidelines under the Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), Federal Drug Administration (FDA) and International Conference on Harmonization (ICH) Suggest recommendations for changes to contracts, budgets, rental ... - 2023 Dec 08