- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical sections of submission documents under guidance of CSL and/or Medical Monitor . Represents Clinical Development on Study Team and collaborates as team member ... This position provides critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. ResponsibilitiesStudy Strategy: Drafts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a fast-paced GMP environment.Key Responsibilities Testing Scheduling Management: Configure, monitor , and maintain job scheduling systems (eg Smart QC, ... system performance and efficiency alongside with analysts' tasks and timeMonitoring: Monitor test execution, adjust schedule as needed to address tests… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with legal and finance teams to ensure timely processing of documents. Monitor and manage payment schedules, approvals, and reimbursements. Ensure compliance with ... organizational policies and procedures related to agreements and payments. Problem Solving: Proactively identify and resolve administrative issues. Anticipate the needs of executives and take steps to address them. QUALIFICATIONSSuccessful candidates will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review ... activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Strategic Planning decision making.- Understanding the Market: Continuously monitor global market trends including multichannel communication and competitive ... intelligence relevant for the DS Oncology pipeline compounds launched brands, and ensure ad hoc analysis can be performed to assess impact of key events that would be material to DS Oncology short and long term Revenue projections. Qualifications: Successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Establishes project plans and calendars for the payroll activities and directs and monitor staff members of their actions during the payroll cycles. Ensures the data ... files transmitted by the various upstream systems (Workday, T Rowe Price, Business Solver, SAP ERP) are correctly processed. Responsible for processing the GL payroll and accrual interfaces for Accounting. Prepares and distributes reports. Initiates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan ... (CSOP).Responsibilities Prior TMF experience required!- Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …L-1 functions to get the appropriate talent assigned to PJ team, and to delegate/ monitor function specific work to each member. Be (or have subordinates be) an ... interface with R&D unit as the CMC working group leader of GPT and ensure alignment across the two Units. Ensure that all or a part of members participate in mutual peer evaluation operated by Tech. Strategy and Planning, Tech. Org. People Enablement (L-2)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …field.- Oversee on-going support for GenAI and other AI solution environments. Monitor and evaluate the performance of generative AI models and algorithms, ... identifying areas for improvement and implementing necessary enhancements.- Continuously evaluate new GenAI research, trends, technologies, tools, and platforms and their applications in the pharmaceutical industry. Optimize and tune data infrastructure and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders to successfully implement regulatory projects, submissions until approval. Monitor submission progress and report project team and submission status ... to Global RACMC management. Develop and implement process improvements to enhance project efficiency. Oversee, manage and maintain IT tools, processes and knowledge management sites. Participate assigned non-project tasks and process improvements. Provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems, controls, motors with voltages up to 600 voltsOperate, monitor , and maintain switchgearWorking knowledge of building automation systems, including ... PLC's, HMI's, sensors, and other componentsFamiliarity working with validated and qualified equipment, and associated documentation requiredFamiliarity with electrical theory, thermal energy principals, mechanical maintenance techniques, and electromechanical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and mitigation strategy to the manager and cross functional stakeholders. Monitor manufacture performance. Identify, investigate and act upon out-of-trend critical ... process parameters (CPP) in-process testing and CQAs.Work with the global MSAT team on global change control and process improvement,RequirementsB.S. or more advanced degree is required, Ph. D is preferred, in related technical disciplines: engineering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience.- Manage, report, and communicate on the global performance of owned processes. Monitor Service Quality and put proactive measures in place to improve it. ... Establish KPIs for systems and services, measure and report the results. Support IT Senior Management by maintaining high service standards.- Analyze and Report on partner performance across all defined metrics and identify trends, opportunities, issues, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operating conditions, you take action to adjust the maintenance plans. You monitor the status of the maintenance checklists and calibration records. You follow ... up the technical works on the basis of an asset management system. You take the lead in new projects and also provide technical support for improvement projects of other departments. You will also look for new technologies / devices to optimize the process.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to pricing, Medicaid, Medicare, and other market access matters and issues.- Monitor current developments in several key legal areas and provides Senior Management ... and other business leaders with updates regarding same (including Legal Affairs Department colleagues). Works independently and, as appropriate, in collaboration with other departments in developing, implementing and presenting training materials on various… more
- Merck & Co. (Rahway, NJ)
- …and opportunities, and drive a transparent prioritization process to monitor risks and dependencies.Stakeholder Engagement and Communication:Act as the chief ... product line goals are achieved.Performance Monitoring and Continuous Improvement:Proactively monitor metrics for value delivery and product performance; implement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure appropriate use of domestic data assets outside of the US Monitor organization data and analytics adherence to regulatory and contractual requirements ... management responsibilities Promote data literacy and governance awareness across NNI Monitor and report on governance outcomes Physical Requirements 0-10% overnight… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to timelines, budget, quality standards and in compliance. Proactively track, monitor and report trial risks, progress/performance, timelines, and financial metrics ... performance, identifying trends, and implementing corrective actions when necessary. Monitor and manage performance of external service providers, escalate issues… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …data insights to improve efficiency, effectiveness, and patient satisfaction Monitor and evaluate the performance of existing programs, identifying opportunities ... skills 5 years pharmaceutical industry experience required Proven ability to monitor , track and develop programs, and adhere to timelines Proven experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …company objectives, ensuring alignment between marketing, medical and market access Monitor financial performance metrics, ensuring revenue targets are met or ... reporting on the effectiveness of Rare Bleeding marketing strategies and initiatives Monitor and evaluate key performance indicators (KPIs) and metrics to track… more
