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Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly desired. Minimum of 10 years drug development/FDA/regulatory related industry experience required.
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Demonstrates knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
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Oversees investigations into adverse drug and device reports with Novo Nordisk products with respect to applicable Federal regulations (IND, NDA, MDR, GMP) and internal SOPs. Serves as a delegate for Executive Director for collaboration with Document Management team and Regulatory Affairs to ensure proper maintenance, retention and archiving of all Patient Safety records.
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5+ years Drug Safety/Pharmacovigilance experience. Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug) 5+ years Drug Safety/Pharmacovigilance experience.
ExpandApply NowActive JobUpdated 4 months ago - UpvoteDownvoteShare Job
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MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process. Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Must have a Licensed Clinical Alcohol and Drug Counselor (LCADC) and Licensed chemical dependency counselor (LCDC) Oversee the development of treatment / behavior / support / safety plans, as needed.
$75,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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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NRG Energy is committed to a drug and alcohol-free workplace. To the extent permitted by law and any applicable collective bargaining agreement, employees are subject to periodic random drug testing, and post-accident and reasonable suspicion drug and alcohol testing.
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The Senior Clinical Trial Physician, Rheumatology sits within Cell Therapy Clinical Development, which is a global organization dedicated to the effective design and execution of drug development.
$270,000 - $305,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA. Highly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
$150ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational. 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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Support Drug Safety Pharmacovigilance, Computer System Validation and GLP. Experience with drug development process – clinical protocol development, global trial management and monitoring, drug safety, biostatistics and programming and/or data management.
$55 - $63 an hourTemporaryExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs.
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Proficient in analytical chemistry or biology background, skilled in analyzing biological drug products (monoclonal antibodies, bispecific antibodies, ADCs) analysis methods, including but not limited to HPLC, UPLC, CE, Elisa.
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Perform routine analytical tests (e.g., SEC, CE, ICIEF, Protein A) to support the upstream and downstream process development. Minimum/at least 2+ years working experience with a bachelor’s or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline.
$40 - $48 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
drug job Title: director safety in Plainsboro, NJ
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