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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The New Jersey Judiciary consists of: the Supreme Court, the Superior Court including the Appellate Division and the Trial Court of the 15 vicinages in New Jersey, the Tax Court and the Municipal Court System.
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Join us as an Outsourcing Manager/BioMarker Operations Manager and play a crucial part in advancing our clinical biomarker and bioanalytical activities. If you meet these qualifications and are eager to contribute to a dynamic team, apply now and help us advance our clinical biomarker and bioanalytical initiatives.
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The Sample Management (SM) Manager, Clinical QC reports to the Associate Director of Clinical QC and will manage the daily operations of the QC Sample Management team and is r esponsible for QC SM scheduling, routine management of in-process, final product and stability samples as well as QC data throughout the sample lifecycle from receipt to disposition.
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Professional Counselor License or NJ Licensed Clinical Social Worker or Marriage and Family Therapy,Professional Counselor. providing direct clinical services to youth and young adults with co-occurring behavioral health and substance use treatment needs.
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Charting System: Altera Digital Health a Harris Company - Paragon, Altera Digital Health a Harris Company - Paragon Clinician Hub, Change Healthcare, Syntellis Performance Solutions - Clinical Exchange, Veradigm Inc - Practice Management, Vox Telehe.
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Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails. Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails.
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Set-up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, clinical study site documents, email correspondence, training materials, etc.
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Within the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large molecule quantitative assay development of biological samples.
$147,000 - $206,333 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Englewood Hospital, a community teaching hospital founded in 1890, consistently earns high marks for clinical excellence and patient safety. Areas of clinical excellence offered by the health system include cardiac surgery and cardiac care, cancer care, orthopedic surgery, primary care, spine surgery, vascular surgery, and women’s health, as well as bloodless medicine and surgery and minimally invasive robotic surgery.
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The Marketing Manager, AHS KOL Engagement will co-lead clinical and non-clinical KOL advisory groups to derive critical insights to advise strategies to advance ETHICON competitiveness and drive sustained growth in this vital growth segment for the organization.
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Ability to interpret and organize highly complex scientific data including reviewing pre-clinical and clinical trial data and output from statistical analyses. The Director will develop collaborative partnerships with the cross-functional Insmed team (Medical Affairs, HEOR, Clinical Development, Advocacy, Commercial and Market Access) as well as external medical experts and will have an integral role in driving the planning and execution of scientific communications deliverables across the Insmed respiratory franchise.
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Access to our Clinical Nurse Liaison Team. Interventional Radiology Nurses (RN) provides critical nursing care to the cardiac patient while assisting the Interventional Radiologist, Vascular Surgeon, and Endovascular Neurosurgeon in performing diagnostic and interventional procedures.
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LAB Division: MLT, LT, Clinical Lab Scientist, Histology Tech, Cyto Tech, Phlebotomist. Imaging Division: Rad Tech, CT Tech, MRI Tech, Ultra Sound Tech, Nuc Med Tech, US ñ Gen/Vasc, LAB Division: MLT, LT, Clinical Lab Scientist, Histology Tech, Cyto Tech, Phlebotomist.
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This position is responsible for designing and maintaining the existing file transfer system MFT product and modules such as Axway, Informatica Enterprise MFT, GoAnywhere, AWS Transfer Service,Knowledge of File Transfer design patterns and data engineering best practicesExperience with AWS data-related services such as EMR, Glue, S3, Lambda.
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clinical trial file jobs Title: trial master file in Somerset, NJ
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