- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four functional areas: Policies & ... This leader plays a critical part in designing and driving the core risk management operations of the E&C team, ensuring the identification, assessment, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management, and cross-functional collaboration to ensure supply continuity, mitigate risk , achieve cost savings, and deliver measurable value through sourcing ... the organization in the CARVYKTI product space.Enhance and Develop Risk Assessment process and periodically update risk score of all BOM and other high- risk … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders to streamline the product lifecycle process and develop risk mitigation strategies.Provide comprehensive quality oversight and strategic quality ... communicated and that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within MA… more
- Merck & Co. (Rahway, NJ)
- …apply regulatory / compliance requirements relative to design controls and risk management activities. Contribute to the development, implementation, and continuous ... and statistical skills with experience in data interpretation and risk assessment tools. Excellent communication, leadership, and problem-solving skills. Ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function ... pharmaceutical industry across different disease areas, and the ability to determine risk factors with and for other technical departments (eg, Clinical, Medical,… more
- Merck & Co. (Durham, NC)
- …Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Aequor (Thousand Oaks, CA)
- …stats programming, TA) to optimize trial delivery. Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally ... to layer to the model which will deliver studies with an appropriate risk -based approach, eg. reduced SDV etc Develop and document standard operating procedures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical ... and regulatory submissions.This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual… more
- Merck & Co. (Rahway, NJ)
- …scope of this group includes strategic program management, enterprise strategic planning, risk management, as well as strategic venture investments in healthcare as ... Commercial Acumen, Communication, Data-Driven Decision Making, Developing Proposals, Enterprise Risk Management (ERM), Environmental Scanning, Influencing Skills, Management Consulting,… more
- Merck & Co. (Rahway, NJ)
- …is expected to execute on the following:Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations.Provides project ... Development, Product Commercialization, Project Leadership, Project Procurement Management, Project Risk Assessments, Quality Assurance Processes, Quality Assurance Systems, Quality… more
- Merck & Co. (Durham, NC)
- …technical documents to support regulatory filings including technical reports and risk assessments Author or approve Change Control documentation for complex ... Diagrams is desired Lean Six Sigma belt certification Experience with process risk assessment tools Experience with responding to regulatory questions with multiple… more
- Merck & Co. (Durham, NC)
- …projects to optimal execution strategies that carefully consider complexity, geography, risk and business impact.Find the best partners for the execution strategy ... input with a keen focus on clear and thorough terms, appropriate risk allocation and insurance coverage.Coach and assess teams' use of lean constructionManage… more
- Merck & Co. (Rahway, NJ)
- …(MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe ... of the audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in continuous improvement, project management, change management, and risk managementResponsibilities: Leadership, Direction, and Strategy:In collaboration with ... manages risks for the data management function and supports functional risk identification/management efforts globally.Serves as the internal Data Management expert… more
- Formation Bio (New York, NY)
- …powered by large language models (LLMs) for classification, recommendation, and risk assessment.In this role, you'll apply cutting-edge machine learning techniques ... and deployment of machine learning models for classification, recommendation, and risk assessment to enhance decision-making in drug development. Build and optimize… more
- Merck & Co. (Rahway, NJ)
- …Plan for each MDCP Program (with target dates) for execution.Leads Quality/Compliance Risk Assessments including Quality Risk Management Plans, mitigation action ... plans (incoming inspection and final assembly processes) for MDCP suppliers.Support the development of our company's supplier device specification based on intended use and user needs which includes defining list of requirements needed to be specified to… more
- Merck & Co. (Rahway, NJ)
- …documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance ... and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management, team facilitation, and strategic planningExperience in commercial… more
- Merck & Co. (Rahway, NJ)
- …and track KPIs for performance, member experience, and operational efficiency. Risk & ComplianceMaintain strong controls and procedures to comply with ... Reg Z, PCI DSS, and FFIEC guidelines.Champion the credit union's enterprise risk management strategy of "Slow Down, Stop, Escalate"Team LeadershipLead and develop… more
- Merck & Co. (Rahway, NJ)
- …enhancing overall productivity.Contribute to improved decision-making, cost savings, and risk mitigation within the IT software asset management environment.Ensure ... Improvement, End-User Training, Global Team Collaboration, Information Technology (IT) Risk Management, IT Asset Management (ITAM), IT Change Management, IT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience in continuous improvement, project management, change management, and risk management. Responsibilities : Leadership, Direction, and Strategy: - ... Program Lead as needed.- Attends study team meetings and provides information on risk mitigation as needed.- Manages the review and approval of data deliverables for… more
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