- Novo Nordisk Inc. (Plainsboro, NJ)
- …records. The associate will support efforts to adapt and optimize systems , implement new technologies, and drive continuous improvement in user experience and ... closely with IT teams and external partners to enhance system performance and data quality Operational Enhancements...& Technology Integration: Support efforts to adapt and optimize systems to improve data entry and reduce… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and FDA requirements Understands PSP operations, including program business rules, SOPs, systems used (including CRM, Safety system and PSP dashboarding tools), ... Safety information, including complete and accurate detail processed into the correct systems Quality monitoring activities to include CRM system case… 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 ... the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring… more
- Genmab (Plainsboro, NJ)
- …gap analysis, capability analysis, and document reference architecture for various R&D systems and functions.Provide data architecture skills to support core ... a pace never seen before. Join Genmab as an Associate Director, Solution Architecture and Engineering, R&D Digital Products...a regulated environment, dealing with GxP (GLP, GCP, GPvP) data and systems .The role requires excellent communication… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in RWE, with a focus on pharmaceutical research Strong knowledge of health care systems in the US, real-world data sources and analytical methods, including ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...you ready to make a difference? The Position The Associate Director, Research Partnerships (RP) is responsible for developing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in-depth analytics in partnership with data strategy teams, utilizing various data sets and systems within the organization to deliver actionable insights. ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... Are you ready to maximize your potential with us? The Position The Associate Manager of Technical Production will be responsible for overseeing the technical aspects… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and ... maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab portfolio of products. This role will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the face of complexity or disagreement Utilizes and enhances procurement and sourcing systems and tools: Follows up on system usage and proactively ensures ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Merck & Co. (Rahway, NJ)
- …verify critical detailsWorking knowledge using and maintaining common IP docketing systems ; including appropriate system policies, procedures, controls, and ... Position Description: The Office of General Counsel is seeking an Associate Director, Trademark Operations to provide docketing and legal operations support… more
- Merck & Co. (Rahway, NJ)
- …and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop ... Risk Management - ISO 14971, EU MDR, ISO 11608 Needle-based injection system for medical use.Familiarity with Design Verification (DV) strategies and mechanical… more
- Merck & Co. (Rahway, NJ)
- … systems (BioSMB, PCC, or similar)Background or experience in data science approaches related to downstream processes and predictive modeling (multivariate ... our Downstream Process Development and Engineering group as an Associate Principal Scientist.- In this role, you will work...and strong communication skills both verbal and presentation of data is required. A track record of leveraging … more
- Insmed Incorporated (New York, NY)
- …and/or product support of appropriate prescribing, improved patient outcomes.Present data on Insmed products to HCPs including physicians, academic institutions, ... knowledge and competency of Insmed therapeutic disease states, products, and competitor data . Serve as a local medical and scientific resource to Insmed for… more
- Merck & Co. (Rahway, NJ)
- …and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director, Value & Implementation (referred to as EDMA) engages ... guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I...assigned TAsProvides a solid understanding of how countries' medical systems and standards of care need to change to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amounts are correct. Directs quarterly audits to confirm all the T Rowe Price system data reconciles with the payroll system . Responsible for providing ... and monitor staff members of their actions during the payroll cycles. Ensures the data files transmitted by the various upstream systems (Workday, T Rowe Price,… more
- Merck & Co. (Rahway, NJ)
- …using the United States Patent and Trademark Office's (USPTO) Electronic Filing System (EFS-Web) and/or Patent Center - Proofread granted patents, with particular ... attention to the granted claims and application data and prepare certificates of correction where necessary -...named and saved in the IP Group's document management system Review contents of patent application files to check… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.Electronic Data Capture (EDC) ... and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems , and fulfillment of data change requests. ResponsibilitiesChange ... change.Take part in impact analysis of changes to IPOS Systems identifying the risks, benefits and assisting with assessing...cross-functionally and be the voice of CSPV on key system and business process decisions, informed by a deep… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …solutions and reuse. 15 E- Maintains detailed Solution Architecture diagrams for ALL systems , integrations, and data flows. Work with the Enterprise Architecture ... gathering, and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems , ETL and integrations. The… more
