- Legend Biotech USA, Inc. (Raritan, NJ)
- …of a rapidly expanding, commercialized CAR-T product portfolio. This position will be reporting to Head of Global Sourcing and will develop and execute a long-term ... with Quality, Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to prepare alternate/secondary sourcing strategies.Achieve cost savings objectives for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and AI toolsWorks closely with the site to gather data and reporting requirements and aligns tools/models/reportingWorks in collaboration with Validation function to ... in driving consistent statistical approaches and defending them to regulatory authorities is desirableExperience in collaborating with internal technical SMEs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaboration across relevant cross functional groups to enable robust training, regulatory compliance, team readiness, and processing of product prior to release ... right first-time executionKnowledge of LMS systemSupports the maintenance and reporting of quality training metricsSupport daily manufacturing activities when… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …path forward for manufacturing issues.Real time review of all documentation, and reporting , in support of process unit operations, in accordance with Good ... will include but not limited to tasks mentioned above.Support regulatory inspections and audits as needed.Consistently perform tasks in adherence… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThe Associate MES Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing ... Global Procedures.Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.Establish key stakeholder relationships with internal and… 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
- 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)
- …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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews ... initiatives for development activities / programs post internal system audit.Support reporting of quality metrics for audits and inspections and execute against… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the terms and conditions of all supported agreements, and any resulting regulatory reports (Sunshine, etc.) that are necessary as a result of the grant ... payments and preparing analytical reports for all reconciliations and Sunshine Reporting across the organization. Ensure the proper disbursement of corporate funds… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identify and leverage synergies across analytics teams.Responsibilities- Data-Driven Insights Reporting and trend analytics: Lead the development and implementation ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a...required- 4 or More Years Experience with dashboarding and reporting tools like Tableau, Power BI and Looker required-… 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
