- Merck & Co. (Rahway, NJ)
- …centralized trade compliance activities, CIT implemented and continues to manage and monitor compliance with the Trade Agreements Act (TAA). CIT is also ... The Associate Director position's core responsibilities are to oversee our Company's compliance related to customs country of origin. In the origin space,… more
- Merck & Co. (Rahway, NJ)
- …trade compliance activities, CIT implemented and continues to manage and monitor compliance with our Company's VCP program. This program provides guidance ... Proof of Payment activities. CIT is primarily responsible for determining trade compliance requirements and processes, as well as executing select trade … more
- Merck & Co. (Rahway, NJ)
- …and upgrade of classification training materials and facilitates training.- They will monitor site and country compliance with all classification policies, ... global classification regulations.--CIT is primarily responsible for executing select trade compliance functions that are best performed on a global level and/or… more
- Merck & Co. (Rahway, NJ)
- …both within our Company network and at contract manufacturing organizations (CMOs).- Monitor cell bank process performance across programs, support timeline creation ... and management of work packages within project teams. Monitor and project resource needs to support technical work packages and on time delivery.Solve technical and… more
- Merck & Co. (Rahway, NJ)
- …enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity.Global Impact:Collaborate with colleagues across the US ... Collaboration:-Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity.… more
- Merck & Co. (Rahway, NJ)
- …Unite diverse internal and external teams to deliver as One Team Champion compliance , safety, and a culture of diversity, equity, and inclusion Foster transparency ... levels of the organization Drive project schedules, set clear priorities, and monitor performance metrics Recognize team achievements and promote a culture of… more
- Merck & Co. (Rahway, NJ)
- …is a DVM/VMD and/or PhD whose primary function is to design, coordinate, monitor , and report clinical laboratory and field studies that will support the regulatory ... Protocol Ensure the timely selection and ordering of study materials. Ensure compliance of administrative aspects of the study (budgets and agreements) with the… more
- Merck & Co. (Rahway, NJ)
- …project management strategies that align with organizational goals and objectives. Monitor project progress, identify risks, and implement mitigation strategies to ... with Agile and Lean methodologies.Knowledge of regulatory requirements and compliance in the pharmaceutical industry.Experience in driving business outcomes through… more
- Merck & Co. (Rahway, NJ)
- …for improvementDevelop and sustain cross-functional stakeholder relationships to monitor the implementation of critical strategic initiatives, ensure alignment, ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …of custom host cell protein (HCP) reagents and highly sensitive immunoassays to monitor the clearance of problematic residual host cell proteins that may impact ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan ... (CSOP).Responsibilities: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 study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … monitor data integrity and identify anomalies indicating potential compliance issues.Determine effective and efficient risk-based approaches for validation and ... PV QA) ensures high standards of data quality and compliance within Global R&D & PV QA. This role... requirements.Data Analytics and Continuous Improvement:Utilize data analytics to monitor and investigate data integrity across systems used for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for specialty pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned, ... Review risk assessment documents stemming from audit outcome to increase compliance within MA function. Improve/strengthen QA engagement with Global Oncology Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Global and Regional HRIT, HR Business, IT, Finance, and external consultants. Monitor market practice and explore opportunities for adopting new features and ... viable solutions for requests regarding new reporting or data warehouse needs. Monitor data formats, correct inaccuracies, and validate the cleansed data against… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify ... to the appropriate governance committee.Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal… more
- Eisai, Inc (Nutley, NJ)
- …This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of ... the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This individual must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure ... with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Annual Financial Plan LE Forecast cycles. Collaborates with business partners to monitor revenue expense performance indicators to provide guidance and insight into ... alliance forecasts as well as Actuals reporting and analysis while ensuring compliance with alliance policies and procedures. Act as Alliance Committee Finance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …leading different investigations work-cells, drive investigations to closure, support escalations, monitor and improve performance metrics for team. They will also ... planning, hiring, development, and performance management of its direct reports. Monitor day to day execution of investigations, maintain investigations metrics… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and compliance . This includes but is not limited to: support to ... business operations.Support facility project initiatives as neededMaintain knowledge of and compliance to all applicable codes and regulations as required. Obtains… more