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Understanding of the drug development process, including regulatory requirements related to pharmacokinetics and pharmacodynamics. The ideal candidate will have extensive experience in the application of pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development, with a focus on modeling and simulation to predict drug behavior, optimize dosing, and improve therapeutic outcomes.
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Collaborate with cross-functional colleagues across multiple departments such as Legal, Privacy, Compliance, Procurement, Drug Safety Unit, Brand Teams, Medical, Regulatory, Specialty National Account Directors, SAS Operations, SAS Data Analytics, USMA Access Leads, Payer Brand Marketers, Field-based Representatives, Trade, Digital and SPP customers.
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Working knowledge Patient Focused Drug Development initiatives, the 2009 FDA "Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" and other relevant guidance and best practices is required.
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Knowledge of the drug development process and clinical research methodologies including experience in clinical trial design, data analysis/statistics and data interpretation; knowledge of regulations, ICH/GCP, adverse event management.
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Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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Required Skills: Excellent understanding of drug discovery /development. We have several projects in mind, which include: Collecting, organizing, and analyzing data about preclinical studies related to Vaccine discovery and development at Client (2 projects.
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We have several projects in mind, which include: Collecting, organizing and analyzing data about preclinical studies related to Vaccines discovery and development at company (2 projects). Organizing and dashboarding our department's in vivo pharmacology program support (multiple therapeutic areas.
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This position supports statistical programming activities for late stage drug/vaccine clinical development projects. US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
$111,400 - $175,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This opportunity offers the following: Competitive Compensation & Generous Paid Time Off Excellent Medical, Dental, Vision and Prescription Drug Plans (K) with company match and discounted stock plan SoFi Student Loan Refinancing Program Career development opportunities within UHS and its + Subsidiaries.
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About Safety AssessmentCharles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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Drug screening, #THC motor vehicle record check and criminal background check will be performed on all new hires. We are looking for leaders who are looking for a company with a strong focus on employee development and career advancement.
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This role requires an extensive knowledge of the roles and responsibilities of Regulatory Affairs spanning both clinical and commercial phases of drug development, and how Regulatory Affairs connects with other functional areas.
$179,250 - $255,250 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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M.D. or PhD with 7-12 years relevant drug development experience required preferably with 5 years in Regulatory. M.S. or B.S. with 12-15 years relevant drug development experience, a majority of which was in Regulatory.
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Recovery Centers of America (RCA) was created in pursuit of one goal: Help 1 million patients achieve a full life of recovery by providing evidence-based alcohol and drug addiction treatment, as well as eating disorder treatment.
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Horsham, PA, US, 19044 For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
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drug development jobs in Blue Bell, PA
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