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FDA resumes in Franklin Lakes, NJ

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Clinical Research Locum Tenens

Manhattan, NY, 10016
... Demographics of Study Participants in Clinical Trials Reviewed in FDA’s Office of Hematology and Oncology Products from January to November 10, 2016. Abstract accepted for poster presentation at The Women’s Health Congress: The 25th Annual Congress. ... - Oct 31

Legal/Compliance Records Manager

Maplewood, NJ
... Maintained a highly regulated and validated Data Management Portal (ZASIO/JORDAN LAWRENCE/ACCUTRAC) to ensure retention specifications and schedules met accurate and up-to-date CFRs based on current laws an regulatory bodies (FDA, SOX, HIPPA and ... - Oct 29

Administrative Assistant Vice President

Fair Lawn, NJ
... Continuing Education of FDA requirements Prepared and assisted in requirements for Pre-Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, including Internal Audits and Global Sponsor Audits (UK, Belgium, China, Japan and India). ... - Oct 28

Supply Chain Business Partner

Morristown, NJ
... • Global accountability for the development and management of an IT quality and systems validation strategy to ensure compliance of all enterprise systems with applicable FDA and ISO regulations. • Led global IT quality systems and compliance ... - Oct 24

Quality Assurance High School

New York City, NY
... -Collaborated with the quality assurance team to ensure compliance with FDA regulations and standard operating procedures (SOPs). - Monitored and followed up with the IT department to resolve technical issues affecting orders and inventory. - ... - Oct 23

Clinical Research Project Manager

Pleasantville, NY
... Currently, AllSource Screening Solutions Agency Auditor FDA and active contributor to the CRF-Code of Federal Regulations Title 21 Mar 29, 2022 for Sponsors and Investigators Education University of Hartford, West Hartford, Agency CT - Bachelor of ... - Oct 21

Medical Director R D

West Orange, NJ
... with the FDA Participate in scientific review of investigator initiated studies and be answerable medically for clinical studies under the direction as well as directing the design, conduct, and analysis and reporting of Phase IV US clinical trials. ... - Oct 19

General Counsel Law Clerk

Chatham, NJ
... and Amgen Manufacturing Ltd., in response to clients’ submission to FDA of a license application for Amjevita® (adalimumab-atto) as a biosimilar to plaintiffs’ Humira® (adalimumab) reference product for treating multiple inflammatory diseases, ... - Oct 12

Supply Chain Warehouse Operations

Newark, NJ
... Work with 3rd party inspectors, USDA, FDA & Foreign Trade. Utilization of 2 WMS Systems, maintaining inventory accuracies of 99%, monitoring capacity levels and tracking productivity. Establish KPI’s to increase efficiencies and set company ... - Oct 10

Nurse Navigator Registered

Bergenfield, NJ
... Helped to maintain the integrity of pharmaceutical and ECOG protocol trials Prepared and submitted amendments, continuing review and serious adverse advents forms for sponsors to HUMC Department of Research, IRB and WIRB Ascertained all FDA and IRB/ ... - Oct 09
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