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The Director, Drug Safety is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for products both marketed and in development.
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You will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. You will be responsible for working within the department level budget and resources.
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BMS is looking for a Principal Scientist with a desire to contribute in the fast-paced early development matrix environment by assessing drug product bio-performance risks, devising mitigation strategies, and providing technical inputs to drug product development teams.
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As an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
$114,375 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Candidate should display technical awareness in various aspects of drug discovery, discovery-development interface, and early clinical development, including advising technical project teams on biopharma risks as they develop dosage forms for clinical testing.
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The Pharmacokinetics, Dynamics, and Metabolism (PKDM) department at Sanofi contributes to the safe and effective therapeutic treatment of each patient by applying appropriate pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development and accelerating the process, where possible.
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Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
$186,000 - $322,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Cancer Pharmacology - Open rank, tenure track faculty position with a research focus in cancer pharmacology including structure-guided drug discovery, DNencoded library screening, PROTAC and other innovative small molecule drug discovery technologies, or therapeutic antibody engineering and development.
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The Senior Principal Scientist will be an CMC analytical lead (CMC-AL) for drug candidates across all stages of development and, as needed, within our commercial product portfolio. + Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer.
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Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports.
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Oversee the development of treatment / behavior / support / safety plans, as needed. Must have a Licensed Clinical Alcohol and Drug Counselor (LCADC) and Licensed chemical dependency counselor (LCDC.
$75,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Company owner has a 45 year track record in marketing and business development management success, so plenty of awesome training and support is available. This is an outbound marketing and business development position covering the Central New Jersey area including Middlesex and surrounding counties.
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Hands-on experience with PK and Human Food Safety studies, estimation of exposures and drug concentrations, validation, method development and sample analysis. Serve as Study Director or Principal Investigator for bioanalytical validation, pharmacokinetic, efficacy, safety and drug metabolism studies in accordance with GLPs. Authors bioanalytical protocols and reports.
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Masters degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development. PhD in Pharmaceutical Science or related scientific field and minimum 3 years experience in pharmaceutical formulation and product development.
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Identification and characterization of the unknown impurities in the drug products and drug substances Method Development/ Method validation development for various dosage forms that includes Tablets, Hard Gelatin Capsules, Oral/Topical Liquids and Powder for oral suspensions.
$35 - $40Full-timeExpandApply NowActive JobUpdated Today
drug development jobs Title: director safety in Somerset, NJ
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