- 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
- Legend Biotech USA, Inc. (San Jose, CA)
- …system in a timely manner, submitting expenses, etcReports adverse events to Legend's Drug Safety department and other internal departments as appropriate per ... salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.Legend Biotech maintains a drug -free workplace. 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
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... projects as the leader of a cross-functional team.--Champion compliance and safety ; promote a culture of diversity, inclusion, and equity.Champion compliance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … development, clinical pharmacology, and/or epidemiology.Oncology expertise requiredClinical safety experience with early phase oncology preferredMust have ... rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product… more
- Federal Transit Administration (Washington, DC)
- … and Oversight (TSO), Office of Safety Oversight and Compliance (TSO-20), Safety Enforcement Drug and Alcohol Compliance Division (TSO-23). Serves as a ... Headquarters and the Regional Office(s) performing a variety of safety related oversight and compliance activities. Duties Help As...activities. Duties Help As a General Engineer (Senior Regional Safety Officer) you will : Senior RSO serves as… more
- CHRISTUS Health (Somerset, TX)
- …with manager).Monitors quality control standards (immunization logs, waived testing, drug sample logs, equipment sterilization logs, etc.).Resolves less complicated ... Mission.Maintains established CHRISTUS Health policies, procedures, objectives, quality assurance, safety , environmental and infection control.Implements job responsibilities in a… 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
- Merck & Co. (Rahway, NJ)
- …characterization 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. (Rahway, NJ)
- …GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation Biologics (NGB) facility at our ... 3-4 exempt and non-exempt employees to support bulk clinical manufacturing of biologic drug substances, and at times will require hands-on approach on the processing… more
- Merck & Co. (Durham, NC)
- …therapies for our patients. We work in the manufacturing plants with a " Safety First, Quality Always" mindset, striving for continuous improvement, and earn our ... Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest,… 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
- 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 ... of generating early clinical development plan and Investigational New Drug applications;-Developing clinical development strategies for investigational or marketed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects and/or identification of issues which may compromise patient dosing or safety . Basic understanding of professional working environment as well as Quality ... with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global… more
- Merck & Co. (Durham, NC)
- …rotation (2-2-3). -The role of Operations Manager at our Company's Durham drug substance manufacturing facility is a manufacturing leadership role. The individual in ... Successful candidate(s) will be assigned to support the purification of the drug substance for our company's vaccine.--Responsibilities include, but are not limited… more
- Merck & Co. (Rahway, NJ)
- …combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter ... support for global and site-specific projects related to combination products and drug delivery systems.Ensure that all activities are conducted with the highest… more
- Merck & Co. (Rahway, NJ)
- …drugsAnalyzing and summarizing 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 clinical development strategies for investigational or marketed… more
- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and ... late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide… more
