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Minimum of 10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority. Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK. Comprehensive knowledge of GLP regulations and all regulatory guidance related to the nonclinical evaluation.
$165,000 - $231,667 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Functional scientific knowledge of clinical pharmacology, pharmacokinetics and dynamics, interpretation of basic safety pharmacology and toxicology data, surrogate marker identification and application, PK/PD drug interactions, in vivo/vitro models and population pharmacokinetics and PK/PD modeling.
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Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File. Responsible for collecting, preparing and reviewing regulatory documentation for IRB submission prior to study start-up.
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Maintain strong knowledge in asthma and COPD to optimize clinical study protocols development and execution. Design study synopses based on the Integrated evidence generation plan. With guidance from the Medical Evidence Generation lead, the new leader will be an integral part of assisting in building the Global Medical strategy in line with the brand strategy supporting development and preparation for the post- launch of dupilumab for asthma and COPD indications in partnership with Regeneron.
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Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan.
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Qualifications Fluent in both English and Spanish required High school diploma or equivalent Must be willing to study and test for x-ray/radiology license upon eligibility. HSA and HRA Saving accounts 340B Prescription plan for discounted medication Life, AD&D, LTD, and STD benefits Employee Assistance Program Traveler Assistance Program 403(b) Retirement PTO Paid Holidays Gym Reimbursement Tuition Reimbursement License Reimbursement Continuing education and more.
$17 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Understands clinical trial operational complexities from study start up through enrollment, quality assurance, and study readout. BS/BA required, and an advanced degree preferred (MD, PhD, MBA, PharmD, etc.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Minimum of 15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority. Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK.
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Order and study diagnostic tests (blood tests, X-rays etc.) Full Time Pain Management Physician Assistant Wanted in Morristown, New Jersey for a Primary Care outpatient office. You’ll be both a health practitioner and an educator, supporting disease prevention practices and helping people lead healthy lives.
$120,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Leads the development of HEOR research project materials including study protocols, analysis plans, reports, value dossiers, and publications building on the high quality and scientific rigor of these deliverables.
$140,000 - $200,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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.) Collaborates in the development of study documents and reports (e.g., study protocol, IB, ICF(s), CSR, periodic safety reports, etc.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Company Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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The first Phase 2 interim analysis of this combination was presented at the European Association for the Study of the Liver (EASL) congress in June of 2023. This role is responsible for shepherding contracts through our internal process, managing our contracting platform Cobblestone, troubleshooting issues, and managing new hire onboarding processes for the Talent Acquisition team.
$100,000 - $115,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
$74 - $78 an hourExpandApply NowActive JobUpdated Today
toxicology study jobs in Basking Ridge, NJ
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