• Insmed Incorporated (Bridgewater, NJ)
    …lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. He/She will be accountable for the day-to-day direction ... to Medical Safety Team to ensure business needs...to Medical Safety Team to ensure business needs and priority tasks...strategic consultation, and guidance to the Medical Safety Leads on decisions that have significant drug more
    HireLifeScience (03/12/24)
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  • Catalent (Harman, WV)
    POSITION SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... all cGMP manufacturing operations and documentation and adhering to safety guidelines Build effective teams that apply their diverse...quality oversight of manufacturing operations and the release of drug substance and/or final drug product to… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …as well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product safety lead or ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...safety team, and be responsible for overall product safety strategy or specific areas of safety more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...global drug portfolio from the Research stage to post marketing/lifecycle… more
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  • Merck & Co. (Rahway, NJ)
    …for the screening of literature on company products to support pharmacovigilance and drug safety and for use in the Product Literature Database.-Responsibilities ... literature acquisition, and searching functions.-Demonstrates expertise in pharmacovigilance and drug safety requirements for literature monitoring.-Creates strategic… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …preferred orPharmD preferred orRN degree preferred Experience Qualifications4 or More Years drug safety experience with technical experience in Electronic Data ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...experience in one or more of the following areas: Drug Safety , Epidemiology, and Clinical Development preferredDaiichi… more
    HireLifeScience (03/19/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …lists.OverviewThe Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    …Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... science that radically changes the way we approach serious diseases.-- - The Director reports to an Executive Director in the Oncology Clinical Research… more
    HireLifeScience (03/05/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical /Clinical Departments. The ... and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative. ResponsibilitiesAdditional… more
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …This Executive Director , the sub-functional lead for Epidemiology group in Global Medical Safety , leads and manages the Epidemiology group and sets the ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...on proper use of automated health care databases for drug safety -related Epidemiologic studies.Mentor junior staff in… more
    HireLifeScience (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …data collection and review system into EDC.SAE Narrative Review: Comparison of the drug safety narrative text against key fields in the clinical database ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...for CRF design at the disease and study level.Data Safety Monitoring Board (DSMB): Clinical Science to be included… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Management Team (SMT) materials.Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports ... Data Review Plan (IDRP)Accountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose… more
    HireLifeScience (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …SummaryPosition leads Epidemiology data analysis activities and/or projects in support of new drug development and/or post-marketing drug safety for the ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...the pharmaceutical industry7 or More Years of experience in drug safety data analysis and/or signal evaluation… more
    HireLifeScience (03/01/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Director , Quality Assurance as part of the Quality team based in Raritan, NJ. ... Role Overview The Director of Quality Operations , CAR-T is responsible for...include Disposition activities , including incoming materials and final drug product, QA shop floor oversight of manufacturing operations,… more
    HireLifeScience (01/31/24)
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  • Insmed Incorporated (San Diego, CA)
    …a clinical study(s) and clinical operations aspects of one or more drug development program(s) in compliance with GCP and relevant regulatory guidelines.Manage and ... materials, pharmacy manual.Approve action plans to address protocol compliance, safety , data, and administrative issues with investigationalArrange and attend site… more
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... teams. This position requires significant understanding of clinical research for drug development, from hypothesis formulation to subject enrollment, use of… more
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support:… more
    HireLifeScience (03/02/24)
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  • Merck & Co. (North Wales, PA)
    …and/or risk managementMinimum 5 years of employment in clinical development, drug safety or regulatory or equivalentDemonstrated organizational leadership ... for assigned marketed products across our company's portfolio of products.-The Executive Director will drive delivery of safety input to clinical development… more
    HireLifeScience (03/19/24)
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  • Catalent (San Diego, CA)
    …supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include ... through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The...audits. Lead or support client audits along with the Director and Associate Director of Quality Assurance.Manage… more
    HireLifeScience (03/22/24)
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