- Formation Bio (New York, NY)
- …pioneer the development of sophisticated models to predict clinical outcomes-determining drug efficacy, safety profiles, and optimal indications-to create a ... AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ...efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the… more
- Genmab (NJ)
- …the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of management experience in PV preferredMinimum of 5 years of Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience in PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; ... preferredExtensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and safety databases,… more
- Genmab (NJ)
- …are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker functions with the ... committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight of programming activities… more
- Aequor (Pearl River, LA)
- …and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting ... to identify biomarkers and molecular signatures relevant to vaccine efficacy and safety . Familiar with state-of-art technology related to bulk RNAseq, single cell… more
- Aequor (Pearl River, LA)
- …and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting ... edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world. ROLE SUMMARY We are seeking a highly motivated full-stack web application developer (contract) with exceptional programming… more
- Taiho Oncology (FL)
- …responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical affairs plans to develop and ... align the tactical plan for Sr. Manager, Medical Field geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, eg medical territory plan Training/Education Resource: Develop, maintain and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as a Biologics Drug Substance Commercialization Leader!Are you ready to take your career to the next level?We are seeking a strategic ... manufacturing and commercialization projects.Why You'll Love This Role:As a Biologics Drug Substance commercialization Leader, you'll be at the forefront of… more
- Merck & Co. (Rahway, NJ)
- …enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact ... Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and Safety , Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support,… more
- Tris Pharma (Monmouth Junction, NJ)
- …apparatusWorking knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health ... Administration (OSHA) regulations and guidancesThorough knowledge of MV parameters and relevance in method performance and method life cycle managementStrong technical writing skills, including SOPs, investigations, protocols and reportsAbility to train and… more
- Tris Pharma (Monmouth Junction, NJ)
- …apparatusWorking knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health ... Administration (OSHA) regulations and guidancesAbility to perform analytical testing, calculations and data analysis, as instructedAbility to perform wet chemistry and physical testings, as instructedProficiency with Microsoft OfficeVerbal and written… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including ... to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for parenteral… more
- Merck & Co. (Rahway, NJ)
- …such that the process is scalable without compromising stability, safety , efficacy, and delivery. -During development, we leverage smart experimental ... In summary, our team enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly motivated candidate for the position of… more
- Merck & Co. (Durham, NC)
- …North Carolina. This new facility will include end-to-end processing of both drug substance and drug product, including product inspection, warehouse, utilities, ... and supports the product transfer for a new facility in Durham, NC within Drug Substance, Drug Product and/or supporting areas.Support and execute to approach… more
- Merck & Co. (Rahway, NJ)
- …drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new… more
- Aequor (East Syracuse, NY)
- …used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and ... for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance, and drug product samples. The candidate will execute… more
- Merck & Co. (Rahway, NJ)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... of generating early clinical development plan and Investigational New Drug applicationsDeveloping of clinical development strategies for investigational or marketed… more
- Merck & Co. (Rahway, NJ)
- …facilities. The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices ... development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency ... salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.Legend Biotech maintains a drug -free workplace. more
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