- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD business process owners ... clinical trial process in support of a proactive quality risk management process. Interact with the...impact. preferredAbility to effectively interact with and present to senior management at all levels, as well… more
- Bickford of Upper Arlington (Columbus, OH)
- Join our DYNAMIC team at Bickford Senior Living as a Wellness Nurse! The Wellness Nurse supports resident care within the branch, ensuring that Resident's daily ... and all of Bickford's policies and procedures regarding medication management .Understand and appropriately utilize the eMAR system for medication… more
- Tris Pharma (Monmouth Junction, NJ)
- …Fosters a culture of quality -by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue resolution, risk ... study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations...of issues for trial or program level deliverables to senior management , etc.); Develops, implements, and/or manages… more
- Merck & Co. (Rahway, NJ)
- …2 years of management responsibility and experience developing staffFluency in the clinical quality management system and CMC process, across modalities ... Co-Leads are responsible for creation and management of the performance management processes that govern operations, including tier, clinical siting and… more
- Catalent (St. Petersburg, FL)
- …compliance enhancements/improvements and leading project to deliver solutions.Collaborates with management and supervisory personnel from operations, quality ... I. Department Overview: The Quality Assurance Department is responsible for providing leadership...in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing… more
- Merck & Co. (North Wales, PA)
- …discretion.Preferred: Cross-functional experience in clinical research (eg, monitoring, data management , clinical quality assurance, study management ... )Experience with risk management tools and processes within the clinical quality framework.Profound knowledge and understanding of clinical development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr . Manager of Operations - Continuous Improvement and Projects as part of the ... be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Exchange, and Dashboards. And in the R&D space including but not limited to clinical trial management system, drug labeling, and learning management ... of data. Responsible for prioritizing team activities and managing quality of the deliverables. Oversee the support and operations...contact of R&D areas including but not limited to clinical trial management system, drug labeling, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr . Associate OpEx Engineer as part of the Technical Operations team based in ... for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and ... (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and other key… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management… more
- Catalent (San Diego, CA)
- …and escalation of quality issues to Site Leadership Team and QA senior management .Lead programs for: QA department budget, Site Training, Supplier and ... CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies...the development of site Quality Objectives, site Quality Plans, Quality Management Reviews,… more
- Eisai, Inc (Nutley, NJ)
- …Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides statistical and ... we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ;… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead...the compounds' life cycle management , with support from management as needed.… more
- Merck & Co. (North Wales, PA)
- …project management skillsDemonstrated success in the assurance of deliverable quality and process compliance.Familiarity with statistical and clinical data ... and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management , Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting… more
- Merck & Co. (Rahway, NJ)
- …a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will ... Quality SystemsExperience in supporting compliance investigations and change management .Familiarity with US and EU GMP and Safety compliance regulationsEffective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Eisai, Inc (Nutley, NJ)
- …business decisions. Can apply financial analysis to build business cases that drive quality decision making and management processes.Travel is estimated at 30% ... this is your profile, we want to hear from you. Senior Manager, US Alzheimer's Strategy and Lifecycle Planning Marketing...and logistics associated with the congress experience.Assist with the management of the brand plan dynamic dashboard to drive… more
