- 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
- 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and capital expenditures (CapEx), ensuring alignment with business objectives, quality, compliance , and cost optimization. The role will work closely with ... goals. The Manager will play a key role in vendor management , contract negotiation, and operational procurement excellence.Key Responsibilities Support and … 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
- Genscript USA Inc. (Piscataway, NJ)
- …and background. This position is based fully onsite in Piscataway, NJ. Responsibilities: Lead and manage all EHS compliance activities and initiatives for the ... for developing, implementing, and managing site-specific EHS programs and ensuring compliance with local, state, and federal regulations. The ideal candidate will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal departments ... on Regulatory Affairs related issues. Essential Functions With direction from management participates on cross-functional teams focused on the planning and execution… 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …and inspire accountability- Ethical, resilient, and committed to excellence- Skilled in risk management , team facilitation, and strategic planning- Experience in ... Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management , Regulatory Submissions, Risk Management ,… 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
- Merck & Co. (Rahway, NJ)
- …Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility of this position is across ... systems and ensure team and company adherence to these documents.Develop a risk -based approach to prioritize USDA compliance requirements for our manufacturing… 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
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... industry.PRD #PRDRequired Skills: Budget Development, Business, Clinical Supply Chain Management , Clinical Trial Management , Compliance Frameworks,… more
