- Daiichi Sankyo, Inc. (Bernards, NJ)
- …file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking ... work in collaboration with the study team and Procurement Management .- Lead trial feasibility and site identification and...philosophy-Responsible for the delivery, oversight, performance and management of 3rd party vendors to ensure … more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed. Lead continuous improvement ... to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance...epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and procedures, including domestic ... favorable debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering, accounts-receivable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... Process for the respective business areas.Responsibilities:Leadership and Project Management : Lead the end-to-end quality execution across Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... and be decisive in an ambiguous environment.Experience and ability to achieve compliance goals through a risk -based approach with a deep understanding… more
- Merck & Co. (Rahway, NJ)
- …point for the docketing team, attorneys, and staffImmediately reports all risk management -related concerns to Senior LeadershipResponsible for the compilation ... Office Suite (Outlook, Word, Excel and SharePoint) and Adobe Acrobat ProStrong project management skills, including the ability to lead and oversee complex… more
- Merck & Co. (Rahway, NJ)
- …, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management , Stakeholder ManagementPreferred Skills: Current ... you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance , and...with site quality teamsRepresent Quality on the Value Chain Management Team and related working groups; lead … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …Key Results (OKRs), Pathway Analysis, Pharmaceutical Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, ... team in our Company's R&D IT brings together product management , engineering, and data science expertise. We enable data,...RaDS Product organization. The position will report to the Lead of the Disease Biology and PharmTox Product Line.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all contracts are executed in accordance with company policies.- Develops and executes risk management strategies designed to protect DSI and DS Group and ... is role is responsible for partnering with DS internal senior stakeholders to lead , assess, develop, negotiate and execute strategic sourcing activities (both US and… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role ... sub-teams to develop best practices for global initiatives in validation, quality compliance and material/ raw material support. The validation scope comprises a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- ValSource, Inc. (Rahway, NJ)
- …is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting ... with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management : Interface with clients, lead teams of validation professionals,… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness,… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutical Industry, Capital Project Management , Capital Projects, Change Management , Cybersecurity Risk Management , Data Analysis, Deviation ... operations (FLEx) and new capital builds, including automation lifecycle management , data/analytics, and site representation on capital projects.- Some off-shift… more
