- Genscript USA Inc. (Piscataway, NJ)
- …for site staff, contractors, and project teams. Support permit applications and regulatory reporting . Lead site inspections, audits, and emergency drills. Serve ... risks. Ensure compliance with OSHA, EPA, and other applicable regulatory agencies. Conduct risk assessments, hazard analyses (eg, JHA,...as a liaison with regulatory bodies and external contractors/vendors. Drive continuous improvement in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines.Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting , and publication.Specifically, the Senior Director ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Rahway, NJ)
- …power of leading-edge science to save and improve lives around the world. Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS ... IT), the Executive Director, Digital Regulatory and Safety, will lead our efforts in transforming regulatory submissions and pharmacovigilance through modern… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time position works ... Summary:We are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The Global Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for direct reports, and mentors DM Operations Data Validation and Reporting staff.Directs programming representation in audits and regulatory inspections ... and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and… more
- Tris Pharma (Monmouth Junction, NJ)
- …monthly, quarterly and annual consolidated financial statements; Assists with regulatory reporting , as applicableResearches and corrects accounting issues ... support in ensuring company financial records remain accurate while meeting reporting deadlines. The incumbent establishes and approves internal controls and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports for medical content, evaluation of expectedness/listedness and assessment of regulatory status for expedited reporting Design, implement, and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...for individual contributors - DO NOT EDIT. Ensure that reporting personnel have individual development plans (IDP), with annual… more
- SMBC (New York, NY)
- …support across the Advisory Function with respect to broker-dealer-applicable regulatory engagements, support function coordination, governance and reporting . ... Change Management + Compliance Alerts and other Communications Governance and Reporting : The Regulatory Governance Team is responsible for producing management… more
- SMBC (Jersey City, NJ)
- …a self -motivated and diligent professional for a full-time position in the Regulatory Reporting - Capital Analytics Department. This position is responsible for ... the Bank Holding Company. + Support analysis of Basel RWA Reporting based on US Regulatory requirements. + Assist in requirements gathering, test case reviews,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Merck & Co. (Rahway, NJ)
- …own the roadmap and governance for Finance, Digital Payments, and SAP reporting /analytics platforms (BW/HANA), and will partner closely with Finance, IT, Operations ... considerations) within SAP and connected ecosystems.Oversee SAP BW and HANA reporting /analytics strategy, ensuring robust data models, timely financial reporting… more
- HSBC (New York, NY)
- …and Americas Finance function. Finance NFRs include, but are not limited to, Financial Reporting Risk, Regulatory Reporting Risk, Model Risk, Data Risk and ... information, and obtain approval through local governance + Lead regional regulatory reporting -focused targeted transaction testing ("TTT") activities in… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... health. This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early and late Development PK/PD… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... health. This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
