- Merck & Co. (Rahway, NJ)
- …with-ICH/GCP and country regulations, our Company policies and procedures, quality standards and-adverse event reporting requirements internally and externally.The ... ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Reviews… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations,-our company's policies and procedures, quality standards and adverse event reporting-requirements internally and externally.The ... with-ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.o… more
- Merck & Co. (Rahway, NJ)
- …of the outside counsel docketing modulePartner with IP Group Leadership, IP Docketing Manager , and the IP Systems Administrator, to develop best in class/best ... and trademark prosecution rules and proceduresProficiency with IP docketing systems , tools, analytical models, and workflow management toolsStrong technical skills;… more
- Merck & Co. (Rahway, NJ)
- …narratives - Collaborate cross-functionally to monitor clinical study data to ensure quality , completeness, and integrity of trial conduct. - Participate in CRF ... the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ProjectYou will partner with CSSM team...will partner with CSSM team members to train on systems and tools to complete tasks and deliverables critical… more
- Merck & Co. (Rahway, NJ)
- …product owners to deliver solutions using Agile methodologies.Collaborate with systems engineers, software engineers, data services, architecture, test engineers, ... of both internal and external resources located on and offshore; manager project in Agile (Scrum) development methodology; planning, organizing, and conducting… more
- Aequor (New York, NY)
- …and supplier performance metric automation. ROLE RESPONSIBILITIES Use the client's systems , tools and reporting capabilities to oversee and communicate GCS budget, ... recommend business operations improvements for GCS. Partner across GCS and quality to measure, and monitor supplier operational performance, establish action plans,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and ... strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process and procedures.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality ... and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems ... Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global DX, and QA-CSV/eCompliance team members… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review issues log, develop risk mitigations strategies and ensure all systems are operating well as designed. Ensures compliance with internal controls ... of all Financial Disbursements technology applications and other linked systems . Translates business / functional goals into appropriate Financial Disbursements… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …any specialty vendors.Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of ... Daiichi Sankyo's existing feasibility related portfolio of platforms, tools and systems . Qualifications: Successful candidates will be able to meet the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification and… more
- Aequor (New Brunswick, NJ)
- …a basic understanding of business specific organizations functions and support systems (manufacturing, packaging, artwork, regulatory, marketing, quality , and ... onsite required for training and once done min 50% required onsite as per manager .Job Summary:The primary function of this role is to lead / participate in a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role Overview ... The Warehouse Operations Manager will work within Technical Operations and be responsible...Support the treatment and on time closure of deviations, Quality investigations and CAPA's related to operational activities. Ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The QA… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... to be incorporated with an automation platform that integrates with MES systems in cGMP manufacturing operations. This effort will extend organizationally to… more
- One Medical (Chinatown, NY)
- …is a primary care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable. But this isn't your average doctor's ... performance are also expanding. We are seeking to hire a General Manager (GM) to drive strategic and operational performance across assigned geographic markets… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across organizational lines to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position is also responsible for ... for the accuracy of project status in the project management information systems , for preparing scope change proposals and stage gate proposals for formal… more
- Eisai, Inc (Nutley, NJ)
- …at least 5 years of enterprise-level governance and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control ... review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory, commercial,… more
