- Merck & Co. (Rahway, NJ)
- …background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible-for execution of all Clinical Trials in ... to GCP, local and global policies and procedures to conduct high- quality , inspection ready-studies is essential. The position is accountable for trial… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a detail-oriented Associate Director of Consolidation Accounting, tasked with the role of overseeing the accurate and timely ... standards. This pivotal position involves coordinating, preparing, and analyzing the financial data reported in the Annual Report as well as SEC filings, including… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research ... Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …incorporating relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ManagementEstablish and enforce robust ... data security and privacy.Implement processes to regularly test, audit and validate HR data to maintain high data quality standards.Conduct system audits,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... updated Core Data Sheets, EU and US Documentation: As the project...Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: Serve as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …searches and report output.For all data requests, perform self-QC of data to ensure quality of results. Service Provider Oversight & ManagementOversight ... of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange Requests for PV Systems Collaborate cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization and contact volume grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality /Safety Associate Director . Interacts ... future capabilities. We're responsible for regulating accounting, upholding workplace safety, managing our supply chain and sampling, supporting technological and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety, managing our supply chain and sampling, supporting technological and ... data innovation, insights and analytics, delivering patient support solutions,...internally or at vendors. Relationships Reports to the Senior Director , Advanced Analytics & Innovation. Works closely across the… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... capabilities and will be responsible for planning, coordinating, and executing timely and high- quality submissions to the FDA.This is a hybrid position based in our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications ... for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs:… more
- Merck & Co. (Rahway, NJ)
- …Quality Attributes and Quality by Design principles, and advanced data analysis for drug development applications.-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...transfer to GxP laboratories.- They will be responsible for managing quality science and effective prioritization to… more
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible… more
