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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.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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7 or more years of experience within pharmacovigilance, clinical pharmacology, preclinical research, toxicology and/or biomarker validation (especially in industry) required. Grow CSPV's connection to toxicology (MSRL) and Precision Medicine beginning at the start of preclinical development.
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Identify research study needs, drafting proposals and protocols, and contribute to real-world evidence (RWE) strategy and study conduct across the Oncology portfolio. Experience with writing protocols in general and particularly the statistical methods sections of observational study proposals and/or proposal requests is required.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Collaboration with other histology analysts, Medical Directors and Scientists in examining test samples and applying gross anatomy understanding in conjunction with the study purpose to dissect appropriate representative samples and tissue orientation for histology testing and analysis.
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Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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In collaboration with medical director, Digital Medicine Lead, QS, and others, design study; execute on sensor-facing aspects of CES study, including liaison with vendor/device collaborator and User Experience Research (UXR.
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System Study, Design, Analysis, Business Process Mapping, Define Process Flow and Procedures, managing and delivering SAP S/4 Hana, ECC, SD, LE, MM,WM,EWM, AFS, Retail, C/4, PI/PO. Gather functional and technical requirements, analyzing client requirements, into project designs to deliver solutions using Solution Manager, BPM, BPML, ASAP and SAP RDS Solutions.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Create or review and approve statistical programming plans at study and project level. Develop and validate programs (SAS or R) to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
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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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Understanding of clinical trial and real-world evidence study design and execution, statistical methods, and reporting requirements. This may include but is not limited to documents prepared by FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ACCME, etc.
Full-timeExpandApply NowActive JobUpdated 13 days ago - 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.
$147,000 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Serve as a principal level Biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work.
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Lead the coordination of cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to study start-up, recruitment, study conduct, and database lock and study close-out with risk and issue management and assurance of TMF inspection readiness.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Target Major(s) or Fields of Study: Film, Media Production, Marketing or Social Media. Proficient in multiple social media platforms including TikTok, Facebook, Instagram, Pinterest, and YouTube.
Full-timeExpandApply NowActive JobUpdated 3 months ago
toxicology study jobs in Bridgewater, NJ
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