- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Lab Oversight Specialist ... role is an exempt level position with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of… more
- Aequor (Thousand Oaks, CA)
- …cross functional environment * Responsible for review and approval of FSP Quality Oversight Monthly reports * As requested, conduct in-person or remote Site Quality ... Visits to promote and maintain site quality and collaborationTop 3 Must Have Skill Sets:Basic Qualifications: \"Doctorate degree OR Master's degree and 2 years of [Job Code's Discipline and/or Sub-Discipline] experience OR Bachelor's degree and 4 years of [Job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. A key focus will be the oversight of, and interactions with, CROs and other external vendors to ensure ... the relevant business areas. Acting as an escalation point for any sponsor oversight issues and CRO quality issues.This role will be accountable for the operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within across the product portfolio by providing governance support, quality oversight of strategic initiatives in close collaboration with cross functional ... lifecycle process and develop risk mitigation strategies.Provide comprehensive quality oversight and strategic quality guidance/advice to the MA functions located… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …potential risks to the study and propose mitigation plans. CRO and Quality Oversight :Responsible for oversight of all CROs utilized within their therapeutic ... Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling...and best-in-class procedures and SOP's related to clinical study oversight and execution.Work with TMF Operations to ensure a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …standards across the organization. This role is responsible for the oversight of employees/activities performed at Global Business Support (GBS) hubs located ... partners to drive global safety standards. Oversee Patient Safety Call Center Provide oversight for the patient safety call center to ensure effective case intake… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities:Reconcile the TMF document trackers generated by the CRO ... and maintain a monitoring review spreadsheet.Compile and maintain CRO Oversight Monitoring (CROOM) visit outputAnalyze study site metrics reports to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across sites Support key projects by providing tailored advice Provide assurance and oversight of the security and resilience status to US Leadership Partner with ... Security Champions network is in place, local needs are understood and oversight is provided Represent Novo Nordisk US, collaborate with law enforcement, support… more
- Novo Nordisk Inc. (Durham, NC)
- …confirmation on shop floor. Handle release of raw materials & provides quality oversight , review & approval of validation activities associated with minor changes to ... preferred Understanding of quality management systems required Understanding of quality oversight & on floor production support required Knowledge in Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process optimization initiatives, and directs operational structures and oversight .This position collaborates within global CSPV and cross-functional teams.As ... Leadership based on business need.Support process mapping and design workshops.Provide oversight and support for operational groups, related processes, and metrics… more
- Merck & Co. (Rahway, NJ)
- …for this position. What you will do: Execute and provides oversight to intravitreal product and process design, development, characterization, technology transfer, ... to science, quality, reliability, schedule, and cost.Provide mentorship, technical oversight , and strategic guidance with respect to intravitreal process… more
- Merck & Co. (Millsboro, DE)
- …our Millsboro, Delaware location. This position will have overall responsibility for oversight and administration of day-to-day operation of the animal facilities as ... to the humane care and use of animals.Responsibilities also include training and oversight of the animal care staff, serving as a designated reviewer and voting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Dashboards, and IT Needs) Scrutinize and help support the identification, consolidation, and oversight of GCO's overall needs on metrics and technology and acting as ... including but not limited to GCO Functional Excellence, Strategic Vendor Oversight , Feasibility and DS Data Governance functions.) Liaise and partner closely… more
- Merck & Co. (Durham, NC)
- …a member of the Engineering, Maintenance and Site Services (EMSS) team providing oversight to calibration employees and the calibration program at the Durham Site.- ... This position will focus on managing calibration technicians, ProCal System Oversight and assisting with successful execution of calibration activities. General… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and objectives for the organization. This person will have strategic oversight planning and execution for global oncology congresses and branding activities. ... partnership with global advocacy as it relates to global oncology congresses.-Full oversight and management of the creative agency- Budget management and control-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of master data and data integrity related to US Talent Acquisition. ... Acquisition on projects related to processes, mergers and acquisitions Provides oversight and direction on processes supported in US Talent Acquisition Ensures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trials. Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the ... are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendors conducting the study to help monitor compliance with Quality Oversight measures. Responsible for staff training, performance management, setting individual ... resume review, interviewing, hiring and onboarding of new staffAs part of Vendor Oversight , meet with contract agencies on a monthly basis to provide performance… more
- Genmab (NJ)
- …a solid scientific foundation existsEnsure proper documentation of work doneKeep oversight and QC essential documents/data provided by vendorsEnsure trial related ... BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable SOPsGive input to eCRF setup, edit… more
- Formation Bio (New York, NY)
- …antibodies, and vaccines. The candidate will also provide analytical development oversight of pre-clinical and clinical-stage large molecule asset acquisitions and ... across the Formation Bio portfolio. Provide analytical development technical oversight for pre-clinical and clinical-stage large molecule asset acquisitions.… more
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