- Eisai, Inc (Nutley, NJ)
- …or user acceptance testing, and integrations with other clinical applications through change management . Maintains the eTMF system including secure storage, ... relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws...and serve as a subject matter expert in TMF Management . This position may be office-based (hybrid) in… more
- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... functional areas.Drive accountability for processes execution throughout GRACS through change management .-Develop, implement and report process objectives and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …for our Company divisional and local site procedures for safety, quality, and regulatory compliance .Understand the big picture, and how activities link to our ... combination products globally.Experience in authoring ISO-13485 and 21 CFR 820 compliance technical documents, design controls, device risk management , medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and… more
- Merck & Co. (Rahway, NJ)
- …Close partnership with colleagues from Formulation Sciences, Device Development, Quality, Regulatory Affairs, Engineering, and Analytical will be required to ensure ... Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have extensive drug product process development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Governance Stewardship will work in areas required for the good day-to-day management of data at Daiichi Sankyo including: the stewardship organization, data ... quality, metadata management , lineage capabilities and the data governance processes surrounding these capabilities, and the data governance program in general. This… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- … compliance , regulatory and legal obligations. In this role on the Regulatory Compliance Team, you will support regulatory oversight of FDAS, ... maintenance of licensesSupervision of all tasks associated with licensing in compliance with statutory, regulatory , and NMLS requirements and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills in technology systems, content creation, word processing software and data management software, and business emailing software as well as intermediate skills ... Operations, candidate is responsible to support the implementation of culture change initiatives, Global QA Transformation activities and project level oversight… more
- Merck & Co. (Rahway, NJ)
- …scale capital projects.Experience in leading and supporting quality investigations and change management .Experience with sterile drug product GMP facility ... of topics spanning equipment and facility design, financial and capital management , team building, process sciences, operational excellence, technical writing, and… more
- Merck & Co. (Rahway, NJ)
- …the activities of lab staff, including scheduling, training, and performance management .Ensure adherence to safety protocols and regulatory requirements within ... GMP product testingExperience in leading and supporting quality investigations and change managementExperience with internal / external audit process and authoring… more
- Merck & Co. (Rahway, NJ)
- …at the Rahway site.Integrates EHS programs into daily operations to assure regulatory compliance , continuous improvement and performance objectives are met ... implementing corrective and preventive action plans.Reviews processes, facilities, procedures and management of change documents to assure conformance to… more
- VNS Health (Manhattan, NY)
- …effective reporting and monitoring, thereby enhancing departmental efficiencies and ensuring regulatory compliance .Acts as liaison for new projects and leads ... the health plan and the State, addressing issues related to BH compliance , regulatory and program improvements, requirements, and other related matters.Oversees… more
- Citizens (New York, NY)
- …the management and delivery of both Regulatory Change Management and the facilitation of the enterprise Compliance Risk Assessment progress. Specific ... this role at Citizens, you will be joining the Regulatory Change Management team which...risk partners to remain apprised of status of ongoing regulatory implementations as well as to ensure compliance… more
- SMBC (New York, NY)
- …of Risk Assessment, Monitoring and Testing, and Regulatory Change Management is a crucial role within the Compliance Department, reporting directly to ... Compliance Risk Assessment, Monitoring and Testing, and Regulatory Change Management . Additionally, the... Compliance Risk Assessment, Monitoring and Testing, and Regulatory Change Management teams, ensuring… more
- Citigroup (New York, NY)
- …Performing timely compliance risk assessments related to SMB Central Operations, regulatory change management and mapping duties. + Appropriately assess ... to include assisting Loans Operations area with risk assessment, regulatory change management and compliance with rules and regulations, and other ad hoc… more
