- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Specialist, Quality Management Systems and Compliance reports to the Director, Animal Health Quality Management Systems and ... Fact Finding Meeting, Product Recall and Health Authority Notification processes.Support monthly Quality Review Committee (QRC) meetings and present on topics… more
- Catalent (Harman, WV)
- …raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review , and other quality system functions, as ... Position Summary The Director, Quality Systems is responsible for the management...report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis. Track… 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 ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma...the development of site Quality Objectives, site Quality Plans, Quality Management Reviews,… more
- American Honda Motor Co Inc (Marysville, OH)
- …and senior executives across North America to strengthen risk management , internal controls, and governance processes among Honda and affilated operations in ... their operations from a compliance, controls, efficiency and risk management viewpoint.The role of the Senior Auditor...throughout the business and support business planning activities. The Senior Auditor may periodically direct and review … more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Merck & Co. (Durham, NC)
- …Senior Calibration Technician position. This individual will partner with Maintenance management , and work with Manufacturing Operations, Quality , and Global ... maintenance, and engineering support for the manufacturing in Durham, NC. The Senior Calibration Technician is recognized as a knowledgeable resource in maintenance,… more
- Merck & Co. (Durham, NC)
- …support for production facility/manufacturing operation. This individual will partner with Quality Operations (QO) Lab Plant Engineering Management as well ... Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and… more
- Merck & Co. (Durham, NC)
- …and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for ... Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior ...production shop floor support as needed.Application of sound project management techniques to meet schedule, budget, benefit realization and… more
- Merck & Co. (North Wales, PA)
- …investigators.-Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.Participates with management in ... Development Statistics. --Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other of our company's Research Laboratories Scientists… 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 ... PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework that enables the company ... for example across various topics, such as clinical trial management , deviation handling, and product quality Develop,...exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. The incumbent can work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and outside organizations as required. Essential Functions Customer Database Management - Healthcare Professional Database: Maintain integration of all existing ... professional portals and external internet sites with ongoing content management functions for all NNI internet sites Manage PRB...all NNI internet sites Manage PRB (medical, legal, regulatory) review of NNI internet site and its waterfall of… more
- Insmed Incorporated (Bridgewater, NJ)
- …the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors in ... Reports and collecting TMF status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on ... on Harmonization (ICH), and other applicable regulations. This includes preparation, review , and approval of CMC documentation for BLA Supplements (PAS, CBE-0,… more
- Merck & Co. (Rahway, NJ)
- …trial teams and in other trial-level development forums.Under the guidance of more senior staff, may serve as the data management lead or perform ... Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program.- Develops… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RD QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including ... management documentation for the QA Head for review at the Quality Leadership level and...impact. preferredAbility to effectively interact with and present to senior management at all levels, as well… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Director, the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across CMR to… more
- Merck & Co. (Rahway, NJ)
- …- Workplace Data Information The Senior Specialist of Real Estate - Workplace Information Management is a new role which will be a key member of the Global Real ... to help enable corporate real estate strategy, financial reporting, and lease management .- The Senior Specialist will work with critical stakeholders to… more
- Eisai, Inc (Nutley, NJ)
- …5%: Supporting any training projects and other department initiatives, to include Senior Management Special Projects, Corporate Task Forces, Large Cross ... with external vendors as well as responsibility for monitoring and managing vendor quality and execution. This role also provides oversight to field based training… more
- Merck & Co. (Rahway, NJ)
- … tool and system development, validation and maintenance, data integrity review and reconciliation, query management , and database lock preparation/execution, ... our company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines. Works with management to maintain the consistent execution of quality global… more
