- 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)
- …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
- 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
- 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
- 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
- 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)
- … of GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality ... (mAb), antibody-drug conjugates, and fusion proteins.Strong grasp of Critical Quality Attributes/QbD/DOE principles and statistical data analysis… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....methods, including registry-based studies, electronic health records, and claims data analysis Proven experience in leading and managing… 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
- 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)
- …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,...production, including equipment, systems, and workflows. Works with the Director of Conference Centre & Studio Operations, as well… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …SQL, Python, Tableau, Power BI, R, or similar) Strong attention to detail, quality control and problem-solving using big data General coding experience highly ... 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)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... and execution to assigned Novo Nordisk, Inc. therapeutic areas. Assist Associate Director with development and execution of annual strategic convention plan and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations perspectives on projects and initiatives. Closely collaborates with BI on data quality , dashboards, and insights. Closely collaborates with Digital on ... 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,...Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating… more
- Genmab (Plainsboro, NJ)
- …Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In addition, this ... a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, Denmark.Main Responsibilities IncludeEngage with… 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....difference? The Position This role sits in the Clinical Data Sciences and Evidence (CDSE) Division. It plays an… more
- Citigroup (New York, NY)
- …of high severity issues and Transformation regulatory commitments across T&BE globally. The Data Quality Assurance Head is a newly created role and will ... team. This role will report directly to the T&BE Head of Quality Assurance. The Data Quality Assurance Head will be instrumental in establishing and… more
