• George Washington University (Washington, DC)
    …informed consent forms to ensure alignment with the final language in the clinical trial agreements, reviews by risk management, Hospital, and University general ... in real time. Collaborates with internal and external legal, finance, compliance, risk /insurance, and clinical operations to include communicating and explaining… more
    JobGet (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …diseases and immune disorders.Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with ... more focus areas (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …DescriptionThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. -In this position, you will have ... a global, cross-functional team.-Responsible for leading specific aspects of clinical /scientific execution of clinical protocol(s). This may include:Serving… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (North Wales, PA)
    …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …rare diseases and immune disorders. Summary Position supports safety monitoring and risk management activities, provides insights on current clinical practice ... to aid the SMT's signal identification efforts.Safety Expert - Signal Evaluation: Assists manager in assessing new signals.Safety Expert - Risk Mitigation &… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionThe Regulatory Project Manager (RPM) is a key member of our company's Regulatory Planning and Publishing (RPP) organization, which operates within the ... larger framework of Global Regulatory Affairs, Clinical Safety, and Pharmacovigilance (GRACS), Operations, Process, & Systems (GRACS OPS). The RPM role sits in RPP,… more
    HireLifeScience (03/23/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …Provide timely and accurate update on the timeline, status of the projects, risk and mitigation strategy to the manager and cross functional stakeholders. ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Manager /Sr. Manager , External Manufacture as part of the Technical Development… more
    HireLifeScience (02/21/24)
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  • Catalent (San Diego, CA)
    …, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
    HireLifeScience (02/14/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …reporting (AR) for investigational and post-marketed medicinal products within the Clinical Safety and Pharmacovigilance (CSPV) department. Since a global vendor has ... Report (DSUR), Periodic Adverse Drug Experience Report (PADER), and Periodic Benefit- Risk Evaluation Report (PBRER), including but not limited to processes for… more
    HireLifeScience (03/15/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ... Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned… more
    HireLifeScience (02/24/24)
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  • Merck & Co. (Rahway, NJ)
    …and approval of documentation to support Good Manufacturing Practice (GMP) - clinical supply API manufacture, testing, release, and maintenance in support of our ... company's clinical supply programs. This person will also independently review...as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality… more
    HireLifeScience (03/23/24)
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  • Novo Nordisk Inc. (New York, NY)
    …Internally, the Diabetes Educator reports to the Health Systems Diabetes Educator Manager (HSDEM). The Diabetes Educator primarily aligns and liaises with the Health ... System Account Manager (HSAM) and/or other internal key health system account...Functions Work with health systems accounts to identify "at risk " patient populations and utilize diabetes education following the… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release and maintenance in support of our ... company's clinical supply programs. This person will also review and...system document approval. - Other duties as assigned by manager for the flexible functioning of the work group.… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (North Wales, PA)
    …single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory ... regions simultaneously.Reviews and provides final approval Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators' Brochures before release from… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The ... is to serve as our Company's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Mobile, AL)
    …impact of those options on patients.- Understand the significance and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products ... with the in-scope customer team: Customer Team Leader, Key Account Manager , Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and more.… more
    HireLifeScience (03/19/24)
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  • Yukon-Kuskokwim Health Corporation (Bethel, AK)
    …Position Summary:This is a grant funded position. Registered Dietitian Clinical Diabetes Educator (non-certified) is primarily responsible for providing ... Type 1 diabetes, Type 2 diabetes, gestational diabetes, and patients at high risk of developing diabetes in a clinic setting. Education is provided via telephonic… more
    JobGet (03/21/24)
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  • Merck & Co. (North Wales, PA)
    …support holistic portfolio management and increased integration of CMC and Clinical strategies.- Position Description/Summary: The CIPM Senior Specialist, Project ... Manager , is a core member of DCTs, partnering with...priorities. Preferred Experience and Skills: Experience and knowledge of clinical drug development strongly preferred; including the different phases… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical Sub-team and ... to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages the team meetings including… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (North Wales, PA)
    …industryA minimum of 3 years of experience in an alliance manager role or equivalent relationship management roleBroad understanding of global pharmaceutical ... biotech industries with a strong understanding of drug discovery and clinical development processes.Superior interpersonal skills and expert team player with ability… more
    HireLifeScience (03/26/24)
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