- 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
- 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)
- …responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The SDL will partner ... standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThe QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. ... resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …MES Project Manager will be part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for ... associated with MES (PAS-X). This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget… 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 execution.Knowledge of LMS system.Supports the maintenance and reporting of quality training metrics.Support daily manufacturing activities when… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …study design, medical monitoring, and medical/scientific interpretation of study analyses,- regulatory reporting , and publication.-The individual will apply an ... Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting , Scientific… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting , publication, and presentation at national and ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… 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
- 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
- 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)
- Job Description Associate Director, Regulatory Submissions Archive Operations - Location: Rahway, NJ (Hybrid role - onsite 3 days per week required) - Functional ... Area: Regulatory Innovation and Information Management (RIIM) within Global ...to lead and influence others outside of a direct reporting relationship.- Demonstrated collaborative skills and ability to work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as Maximum Fair Price ("MFP") effectuation requirements consistent with regulatory requirements, NNI policies and procedures and Sarbanes-Oxley regulations. ... processes, oversee general management, and modifications in the event of regulatory changes. Supports analytics, good faith inquiries, complaints, and post payment… more
- Merck & Co. (Rahway, NJ)
- …:This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and ... function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pricing implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds a broad ... implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Continuously identifies and prioritizes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a collaborative, inclusive and high-performing team culture Utilize analytics and reporting dashboards to identify reimbursement issues with geographies across the ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Ensures timely execution and follow-up. Meets… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …training and real-time monitoring to ensure all activity adheres to regulatory requirements Collaborate closely with Media Relations, Enterprise, Executive & ... visual communications Experience setting goals around audience growth and associated reporting Leadership to appropriately guide, mentor and develop team members… more
