- Genscript USA Inc. (Piscataway, NJ)
- …programs for site staff, contractors, and project teams. Support permit applications and regulatory reporting . Lead site inspections, audits, and emergency ... and background. This position is based fully onsite in Piscataway, NJ. Responsibilities: Lead and manage all EHS compliance activities and initiatives for the site.… 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 ... disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... lead and influence others outside of a direct reporting relationshipBroad organizational awareness and knowledge of touch points/interdependenciesDemonstrated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our ... own the roadmap and governance for Finance, Digital Payments, and SAP reporting /analytics platforms (BW/HANA), and will partner closely with Finance, IT, Operations… more
- Genmab (NJ)
- …RoleGenmab is currently seeking a Director, HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate, high profile, high impact ... team, and work in a highly dynamic and collaborative setting.The Director, HEOL Team Lead is part of the US Field Medical Affairs leadership team responsible for the… more
- USAA (San Antonio, TX)
- …of what truly makes us special and impactful. The Opportunity Our Financial Accountant Lead supports USAA's accounting and reporting teams as it relates to ... development and implementation. Reviews and actions on complex accounting and regulatory standards with the ability to effectively communicate and provide expert… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role ... innovation, pioneering work and evolving best practices.The Global Sourcing Category Lead is responsible for leading global sourcing activities for direct materials… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Novo Nordisk Inc. (WA)
- …health outcomes. Are you ready to realize your potential? The Position The Team Lead , State Government Affairs oversees the State Lobbyist team, in all aspects of ... Oversees and ensures accurate and timely compliance with all lobbying-related reporting requirements for NNI personnel. Relationships This position reports to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …systems and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and delivery of training on case ... processing, safety reporting , and relevant regulatory guidelines (FDA, EMA,...make adjustments based on feedback, compliance audits, and evolving regulatory standards Key Area #2 Lead the… 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
- 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...Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case Processing team,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance ... with Global PV regulations for individual case safety and periodic reporting . Serves as the key DSI contact for PV service providers to address, escalate issues… 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
- Capital One (Petersburg, VA)
- …and drive the implementation of our strategy. Specifically, in this position, you will lead the IRIS team within the ES Division at Capital One, and focus on ... contributions will drive organizational change through risk identification, measurement, analysis and reporting in order to better manage the company's risk in an… 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. ... regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around development of new signal workflow/process,… 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
- City National Bank (Phoenix, AZ)
- …Issue Management, Scenario Analysis, Risk Appetite, Products and aggregating and reporting of operational risk information to the Management Risk Committee, Risk ... and assessment; risk measurement; risk controls; and risk monitoring and reporting to improve operational resilience. WHAT WILL YOU DO? All responsibilities… more
- Insmed Incorporated (NJ)
- …for creating and implementing programs that ensure workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key duties ... Insmed's Director of Environmental Health & Safety (EH&S), the individual will lead the development, implementation, and management of a company-wide EH&S program… more
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