- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …roadmap, leading innovation, communication strategies, identifying and managing KPI's, reporting strategies, and the implementation of system enhancements in areas ... role will streamline business requirements, evaluate, and prioritize project and change request timelines, and ensures seamless integration with existing and… 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...complex points to a variety of stakeholders and drive change through persuasion but not organizational power required- 4… more
- Merck & Co. (Rahway, NJ)
- …database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine regulatory ... regulatory requirementsPreferred Experience and Skills:Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)Ability and… more
- Eisai, Inc (Nutley, NJ)
- …or user acceptance testing, and integrations with other clinical applications through change management . Maintains the eTMF system including secure storage, ... TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements . Th is role also provides direction, leadership and training… more
- Merck & Co. (Rahway, NJ)
- …The-Clinical Trial Coordinator CTC supports clinical supply & non-clinical supply management and ensures timely maintenance-of tracking and reporting tools, ... trial databases (CTMS) and trackersClinical supply & non-clinical supply management , in collaboration with other country rolesManage Labeling requirements and… more
- Merck & Co. (Rahway, NJ)
- …non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.The role is critical to meet planned Site Ready ... trial databases (CTMS) and trackersClinical supply & non-clinical supply management , in collaboration with other country rolesManage Labeling requirements and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry guidelines, specification & critical limitsServes ... product meeting or exceeding the standard of various health authorities. Stakeholder management is required to drive and implement process validation program efforts… more
- Rose International (New York, NY)
- …governance framework that improve the quality and value of data to meet regulatory commitments and enhance risk management . Knowledge and experience of ... in a front office environment Industry experience in data, data management and/or regulatory initiatives Knowledge of data methodologies/frameworks and… more
- Axelon Services Corporation (New Brunswick, NJ)
- …Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management , Documentation, Training, Audits ... following: o Act as team lead for coordinator of work associated with complaints, change control, deviation, CAPA and document management in the applicable ExM… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …associate, operations, and service management team. Adoption leadership and coordinating change management are responsibilities that are part of this role. ... technology portfolio management and planning, and/or large complex program management experienceExperience with Change Management a plusExtensive program… more
- VNS Health (Manhattan, NY)
- …culture of strategic thinking and growth, encourage the team to embrace change , adapt to evolving healthcare landscapes, and consistently pursue excellence in ... manner.Engages in and contributes to the interdisciplinary team's utilization management activities and recommended interventions for members/participants. Establish procedures… more
- SMBC (Jersey City, NJ)
- …objectives, and monitoring and evaluating work. This position works closely with Director of Regulatory Reporting Change Management Department to ensure ... employees. **Overview** The firm is going through a multi-year Regulatory Reporting Transformation program and this position...program and this position reports into the Director of Change Management Department. You will work with… more
- SMBC (Jersey City, NJ)
- …science, engineering, accounting, finance, or a related field + Experience in Banking, Regulatory Reporting and Risk Management projects + Excellent verbal ... employees. **Background** This position reports into the Vice-President of Change Management Department and will work with...the Data and Technology Departments to carry out the regulatory reporting automation within FAD Controllers to… more
- Scotiabank (New York, NY)
- …document requirements of regulatory changes in accordance with the Bank's Change Management Policy. + Responsible for coordinating requested information and ... Senior Manager, Regulatory Reporting **Requisition ID:** 206287 **Salary...reporting process in accordance with the Bank's Issue Management Policy. + Maintain awareness of regulatory … more
- Scotiabank (New York, NY)
- …banking/broker-dealers), including financial close, financial and management reporting , booking model, financial projection and analysis, regulatory ... Manager, US Finance & Regulatory Reporting - Audit **Requisition ID:**... reporting controls, specifically, financial close, financial and management reporting , booking model, financial projection &… more
- Mizuho Corporate Bank (New York, NY)
- About the Team: Mizuho Americas Finance - Financial Regulatory Reporting is a team responsible for the preparation of regulatory filings for multiple ... authorities. You have working knowledge of financial accounting and regulatory reporting , as well as an understanding...( eg Internal Auditor, Quality Assurance, and FRB) and Change Management Forum + Monitor and e… more
- Citigroup (New York, NY)
- …govern processes for Finance Regulatory Engagement & Oversight, including exam management , regulatory reporting , meetings and requests for information. + ... and internal stakeholders informed on the status of regulatory responses, internal reporting , monitoring and governance....skills in order to guide teams on following risk management and controls practices and internal reporting … more
- SMBC (Jersey City, NJ)
- …a self-motivated and diligent professional for a full-time position in the Regulatory Reporting Analysis Department. The individual will be partnering with ... Regulatory Reporting Analysis team members and business... Regulatory Reporting Analysis team members and business stakeholders to assist...of 7 - 10 years knowledge and experience in change management / in a business analysis… more
