- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:We're looking for an Associate , Regulatory Operations on the Regulatory team to help us ... possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Operations , you'll be responsible for the publishing, management,… more
- Merck & Co. (Rahway, NJ)
- …Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory ... 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end ...Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing ... the operational execution of the company's Global We're looking for an Associate Director, Medical Review Committee Operations , on the Medical Review team to… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJOB DESCRIPTION SUMMARY Primary activities include but are not limited to: The Associate Principal Scientist is a DVM and/or PhD whose primary function is ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts ... through launch and post-market surveillance. Key Responsibilities and Activities: The Associate Principal Scientist, Device System - Device Risk Management will be… more
- Eisai, Inc (Nutley, NJ)
- … regulatory developments and assess their impact on business operations . Collaborate with Government Affairs colleagues to proactively address public policy ... your profile, we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic, business-minded, and...support the HR team on HIPAA compliance and broader regulatory obligations (including ERISA, COBRA, and ACA) as they… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Technical Operations team based in Raritan, NJ.Role OverviewThe CAR-T Warehouse Operations Associate will be part of the Technical Operations team ... schedule.Key ResponsibilitiesServe as a subject matter expert for warehouse operations and perform daily warehouse operation processes, including inbound, outbound,… more
- Insmed Incorporated (NJ)
- …clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations , Regulatory , and Clinical Development, as well as with ... the future of science, we're in. Are you?About the Role:The Associate Director, Programming provides technical leadership and ensures adequate programming support… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and ... Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to be an industry leader in problem-solving,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Associate Director, Engineering as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Director of ... responsible for the management, development, and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ensures that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …we work together to change lives for the better. The Position The Associate Director, Media Relations & Issues Management is accountable for establishing and leading ... interacts with senior leaders across all areas of Novo Nordisk US Operations (USO), including USO President/Executive Office, Commercial, Market Access and Public… more
- Merck & Co. (Rahway, NJ)
- …robust operation while maintaining compliance with all current regulatory expectations.-Receives assignments, direction, and technical guidance from leadership ... Development Batches to meet Clinical Development Program requirements.-Partners with Quality, Operations , Technology, and Financial to value these efforts to develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent ... certification program to ensure adequate qualification of auditors per regulatory expectations.Risk Management and Vendor Performance: Responsible to ensure the… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for an Associate Director, IT Marketing Technologies, on the Information Technology team to help us ... data governance, and compliance policies (including privacy, consent, and regulatory requirements).Provide technical ownership of the Salesforce Marketing Cloud… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide...the deal while fully compliant with all legal and regulatory guidelines (in collaboration with legal counsel). Develops solutions… more
- Merck & Co. (Rahway, NJ)
- …to training and education activities supporting the monitoring roles in clinical operations eg -Clinical Research Associate (CRAs), Clinical Research Managers ... experienced and highly motivated individuals to join our team for a Clinical Operations Educator position. As- Clinical Operations Educator you will be f… more
- Genmab (NJ)
- …and operational risk analysis.Serve as a senior strategic partner to Development Operations (DevOps), Clinical Strategy and external partners to inform study design ... incorporating internal and external data sources, novel technologies, and evolving regulatory and business needs.Mentor and provide strategic guidance to … more
- Sumitomo Pharma (Trenton, NJ)
- …coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Ensure compliance with ... is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused...highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The … more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... lifecycle. Our department bridges the gap between technical development, manufacturing operations , and global regulatory authorities to ensure compliance while… more
- GRAIL (Trenton, NJ)
- …other relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations , and other stakeholders to support regulatory strategy ... For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal… more
