• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    … studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
    HireLifeScience (03/09/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and immune disorders.Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations . This position ... CSPV and with CROs to execute study start up processes.ResponsibilitiesGlobal PV Operations Representation on Clinical Study Teams: Represents PV Operations more
    HireLifeScience (03/19/24)
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  • Merck & Co. (Rahway, NJ)
    …for the execution of the Merck clinical research portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management ... making your impact today.- - Overview:- - - Global Clinical Trail Operations (GCTO) is a global...and operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project… more
    HireLifeScience (03/08/24)
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  • Merck & Co. (Rahway, NJ)
    …among the intellectually curious, join us-and start making your impact today.Overview: Global Clinical Trail Operations (GCTO) is a global organization with over ... May interact with internal and external stakeholders (eg, country operations , committees, vendors) in support of clinical ...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your… more
    HireLifeScience (02/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    … setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of ... reports and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected to identify, generate and execute… more
    HireLifeScience (03/01/24)
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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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  • Novo Nordisk Inc. (Plainsboro, NJ)
    About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... The Position Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within the… 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 ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you...your employment may pose an undue burden to business operations , in which case you may not be offered… more
    HireLifeScience (03/22/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …manner Business Advisement: Understand the Novo Nordisk value chain, eg, research, clinical development, manufacturing, and commercial operations to be in ... About the Department The Finance and Operations dept. brings insights and intelligence to inform...and business solutions to attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide… more
    HireLifeScience (02/28/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Sr. Manager of Operations - Continuous Improvement and Projects as part of the ... Technical Operations team based in Raritan, NJ. Role Overview This...responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual… more
    HireLifeScience (02/16/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities.… more
    HireLifeScience (03/01/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …batch records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor as part of the Technical Operations team based in… more
    HireLifeScience (02/27/24)
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  • Merck & Co. (Rahway, NJ)
    …which operates within the larger framework of Global Regulatory Affairs, Clinical Safety, and Pharmacovigilance (GRACS), Operations , Process, & Systems ... Job DescriptionThe Regulatory Project Manager (RPM) is a key member of our...your employment may pose an undue burden to business operations , in which case you may not be offered… more
    HireLifeScience (03/23/24)
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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 ... member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
    HireLifeScience (02/14/24)
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  • Catalent (Philadelphia, PA)
    Warehouse Materials Manager Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Warehouse Materials Manager . The Warehouse Materials ... located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical more
    HireLifeScience (02/13/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial role in supporting ... both the commercial and clinical supply chains at Insmed. The primary focus is...implement strategic plans for the supply chain and logistics operations .Identify and assess potential risks in the supply chain… more
    HireLifeScience (03/12/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …include, but not necessarily be limited to, the following: Manage day-to-day operations of the GxP function within ITCoordinate all validation activities with ... responsibility for computer systems specifically QMS, LIMS, CTMS, and other Clinical and Manufacturing systems.5+ years' experience with Veeva QualityDocs /QMS5+… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionThe Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent 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… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …systems residing in both - our Research & Development Division, - API Operations and Rahway Site Operations .-The Team supports facility operations , ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
    HireLifeScience (03/26/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the respective clinical programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical ... working and new technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence,… more
    HireLifeScience (02/24/24)
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