| Resume alert | Resumes 1 - 10 of 233 |
Clinical Research Associate
Raleigh, NC
... Enforced FDA regulations across all studies, promptly identifying safety concerns and reporting findings to Medtronic and institutional review board (IRB). Audited complex study data for accuracy, uncovered discrepancies, and delivered group ... - Sep 08
... Enforced FDA regulations across all studies, promptly identifying safety concerns and reporting findings to Medtronic and institutional review board (IRB). Audited complex study data for accuracy, uncovered discrepancies, and delivered group ... - Sep 08
Lab Technician Customer Service
Wilson, NC, 27893
... Followed all safety regulations and safety standards set by FDA and company policies. Keep records of all discrepancies and production using in house data. Collins Aerospace Mechanical Assembler 1 September 2020- Reads and interrupts and follows ... - Sep 03
... Followed all safety regulations and safety standards set by FDA and company policies. Keep records of all discrepancies and production using in house data. Collins Aerospace Mechanical Assembler 1 September 2020- Reads and interrupts and follows ... - Sep 03
Technician Iii Team Leader
Wilson, NC, 27893
... Fire Safety Training (ERT) -Adept with SOPs (Standard Operating Procedures), BPRs (Batch Processing Records), cGMP (current Good Manufacturing Procedures), GDPs (Good Documentation Practices), FDA and OSHA Regulations, aseptic core gowning ... - Jul 19
... Fire Safety Training (ERT) -Adept with SOPs (Standard Operating Procedures), BPRs (Batch Processing Records), cGMP (current Good Manufacturing Procedures), GDPs (Good Documentation Practices), FDA and OSHA Regulations, aseptic core gowning ... - Jul 19
SAS Programmer / Administrator / Atlassian Expert
Raleigh, NC
... Regulatory Excellence - Maintained a flawless record of regulatory compliance throughout tenure, representing the data management function in all relevant FDA meetings. Contributed to successful NDA, BLA, and medical device submissions to FDA and ... - Jul 17
... Regulatory Excellence - Maintained a flawless record of regulatory compliance throughout tenure, representing the data management function in all relevant FDA meetings. Contributed to successful NDA, BLA, and medical device submissions to FDA and ... - Jul 17
Clinical Trials Data
Raleigh, NC
... Knowledge of FDA/ICH guidelines and industry standard practices regarding programming. Knowledge of clinical trial design and basic statistics towards analysis. Developing safety and efficacy analysis datasets from raw data and flat files. ... - Jun 28
... Knowledge of FDA/ICH guidelines and industry standard practices regarding programming. Knowledge of clinical trial design and basic statistics towards analysis. Developing safety and efficacy analysis datasets from raw data and flat files. ... - Jun 28
Quality Assurance Qa Engineer
Raleigh, NC
... ●FDA documentation requirements. ●Medical devices testing like IEC62304, ISO14971, IEC60601 Environment: Selenium IDE, Web Services, SOAP UI, SOAP, Eclipse, JavaScript, SQL, Windows, Agile Company: Daksha Info Services, Bangalore, Karnataka, India ... - Jun 13
... ●FDA documentation requirements. ●Medical devices testing like IEC62304, ISO14971, IEC60601 Environment: Selenium IDE, Web Services, SOAP UI, SOAP, Eclipse, JavaScript, SQL, Windows, Agile Company: Daksha Info Services, Bangalore, Karnataka, India ... - Jun 13
Associate Director, Clinical Data Management
Raleigh, NC
... Highlights/Successes oDM SME for successful FDA Inspection of KAR-XT (Emergent Program) 2024 oSupported KAR-XT NDA submission 2023 oLed DM oversight initiative: Data Planning and Risk Mitigation 2023 oRe-vamped a comprehensive departmental oversight ... - Jun 06
... Highlights/Successes oDM SME for successful FDA Inspection of KAR-XT (Emergent Program) 2024 oSupported KAR-XT NDA submission 2023 oLed DM oversight initiative: Data Planning and Risk Mitigation 2023 oRe-vamped a comprehensive departmental oversight ... - Jun 06
Package Handler Warehouse Associate
Louisburg, NC
... Assisted in monitoring children indoors and outdoors during recess ● Helped prepare nutritious meals and snacks according to the FDA safety regulations ● Organized activities and games to increase physical activity for children over the age of 6 ... - May 20
... Assisted in monitoring children indoors and outdoors during recess ● Helped prepare nutritious meals and snacks according to the FDA safety regulations ● Organized activities and games to increase physical activity for children over the age of 6 ... - May 20
Case Management
Raleigh, NC
... Prior Authorization Processes, and Switching Infusion Sites as well as Healthcare Providers Reporting and Complying with FDA for Adverse Events and product Complaints, while Educating Patients on Processes of Replacement Doses Working with Biogen ... - Apr 30
... Prior Authorization Processes, and Switching Infusion Sites as well as Healthcare Providers Reporting and Complying with FDA for Adverse Events and product Complaints, while Educating Patients on Processes of Replacement Doses Working with Biogen ... - Apr 30
Clinical Operations Project Manager
Garner, NC
... ·Obtained project information, analyzed data, and prepared documents for FDA regulatory submissions. ·Reviewed protocol documentation according to regulatory compliance in preparation for audit review. ·Created work instructions guide and trained ... - Apr 04
... ·Obtained project information, analyzed data, and prepared documents for FDA regulatory submissions. ·Reviewed protocol documentation according to regulatory compliance in preparation for audit review. ·Created work instructions guide and trained ... - Apr 04