| Job alert | Jobs 41 - 50 of 612 |
Reg Compliance/Human Subjects Protection Supervisor
Valley Health System
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Ridgewood, NJ, 07451
... Basic working knowledge of biological principles and scientific methods and basic working knowledge and experience in federal regulations governing human subject research and federal reporting requirements (OHRP, FDA, HIPAA, ICH GCPs, etc.) and ... - May 07
Senior Manager, Programming
Takeda Pharmaceutical
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Manhattan, NY, 10037
... Prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; Lead and organize study level programming and oversight activities for analysis ... - Jun 04
Regulatory Affairs Manager (Englewood Cliffs, Nj)
Hiossen
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Englewood Cliffs, NJ
... Manage and submit 510(k) submissions and handle communications with the FDA, including pre-submissions. Coordinate with the team to monitor the progress of certain products submitted by Osstem Regulatory Affairs departments. Collaborate with ... - Jun 05
Manager, Global Regulatory Affairs CMC
Takeda Pharmaceutical
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Newark, NJ, 07175
... Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments. Up to 20% remote work allowed. Full time. $133,200.00 to ... - Jun 03
Manager, Statistical Programmer
Takeda Pharmaceutical
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Jersey City, NJ
... prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; perform statistical analysis using various SAS procedures such as Freq, ... - Jun 03
Mammography Technologist - Per Diem - Livingston, NJ
Onsite Women's Health
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Livingston, NJ, 07039
... Maintains all QA documents necessary to exceed Annual FDA Inspection requirements. Is responsible for obtaining and maintaining ACR accreditation. Exceptional compensation for the right candidate! Experience: Mammography: 2 years (Required) License: ... - Jun 03
QC Analyst- (Quality- OTC Lab)
Englewood Lab, Inc
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Totowa, NJ
... calibrations and system suitability under supervision Familiar with USP/NF Compendia, ASTM, ISO Stds Familiarity with US FDA 21CFR Part 210 & 211 (Drug Product) and Cosmetic GMPs is mandatory Requirements Bachelor’s degree in Chemistry or related ... - May 31
Clinical Trials Quality Assurance Manager
Planet Technology
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Secaucus, NJ, 07094
... This also requires strong knowledge of GCPs, ICH Guidelines and FDA regulations related to Clinical Research, and prior experience in Clinical Quality Assurance. Other requirements include a working overview of the drug development process, ... - May 19
Manager, Global Regulatory Affairs CMC
Takeda Pharmaceutical
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Manhattan, NY, 10261
... Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments. Up to 20% remote work allowed. Full time. $133,200.00 to ... - Jun 03
Senior Analytical Scientist
Hartz
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Secaucus, NJ, 07096
... * Proficient in writing Standard Operating Procedures (SOP's) and reports that meet the cGMP requirements of both EPA and/or FDA using Microsoft Office * Strong written and verbal communication skills * Demonstrated ability to work independently * ... - Jun 02