- 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
- 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)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Merck & Co. (Rahway, NJ)
- …operational support and ensuring the smooth functioning of our procurement processes. Reporting to the Global Capital Procurement PMO Lead, the Specialist will ... with PO and invoicing issues, manage expedited payment requirements per regulatory requirements Contractor Invoice Management : Process purchase orders for… 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
- 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 ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… 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
- DWS Group (New York, NY)
- …and processes. Assist in tracking/management of annual tax returns/1099s/K-1's, regulatory reporting requirements and loan compliance requirements. Collaborate ... is a wholly owned subsidiary of DWS. IAO is responsible for the financial reporting and certain operational aspects for investment vehicles to be launched as part of… more
- Merck & Co. (Rahway, NJ)
- …contract negotiations, and ensuring compliance with company policies and processes. - Reporting to the Director of Capital Procurement Project Execution within the ... to measure progress on all metrics and address any issues. Ensure timely reporting by suppliers in the proper IT system to drive consistency. Continually drive… more
- Merck & Co. (Rahway, NJ)
- …business architectural models and strategic plans to support Development IT initiatives. Reporting to the BIA team lead, the Senior Specialist / Business Architect ... data and data standards across Clinical Development, Medical Affairs, and Regulatory Affairs domains. Apply domain knowledge to influence system design,… more
- DWS Group (New York, NY)
- …efficiency and processes. Assist in tracking/management of annual tax returns/1099s/K-1's, regulatory reporting requirements. We are looking for: Minimum of ... launch process from an accounting perspective, ensuring relevant accounting and reporting systems are set-up. Primary contact of select investment vehicles, which… more
- Merck & Co. (Rahway, NJ)
- …We use state-of-the-art techniques for financial analysis, planning, accounting, reporting , and performance evaluation. This allows the organization to continue ... acumen such as product knowledge, healthcare systems, payors and customers, regulatory , business operations and reputational risks while working intimately with our… more
- The Calyx Institute (New York, NY)
- …compliance between Calyx and awarded applicants, regarding contracts, legal and regulatory issues, deliverables, reporting , payment, etc.; and maintaining clear ... messaging. In collaboration with the finance team, ensure proper compliance and reporting for all grant recipients. Coordinate and oversee the selection panel… more
- Lundbeck (New York, NY)
- …Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and ... account plans Strong analytical background, and experience using sales data reporting tools to identify trends Experience in product launches Previous experience… more
- Lundbeck (New York, NY)
- …Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations ... therapeutic class Strong analytical background, and experience using sales data reporting tools to identify trends Strong leadership through participation in… more
- Formation Bio (New York, NY)
- …savings, contract optimizations, and risk mitigation. Implement procurement analytics and reporting tools to provide visibility into vendor spend and procurement ... trends. Stay informed of industry trends, supplier market dynamics, and regulatory changes impacting procurement. About You Bachelor's degree in business, finance,… 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
