- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outsourced or contracted activities utilizing both performance and quality measurements.The Associate Director , SCBM Financial Reporting & Strategy position ... management and liaises with internal/external stakeholders on cross-functional initiatives.The Associate Director , SCBM Financial Reporting & Strategy's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic development, ... and implement a monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures as outlined… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide...optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and ... Operations team works closely with the business across the...and Payer), Brand Marketing, Training, Market Access, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has… more
- Merck & Co. (Rahway, NJ)
- …for CLIC.- Maintains up-to-date awareness of biomedical literature, copyright compliance , adverse event reporting, and information storage and retrieval systems.- ... to ensure optimum performance, reliability, data integrity, security, and copyright compliance . -Directs the development, maintenance, and control activities of CLIC… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and HQ counterparts to promote quality and consistency across regions. Ensure compliance with SOPs, KPIs, internal processes; Track and measure specific CMR ... processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management. Collaborates… more
- Merck & Co. (Rahway, NJ)
- …completion of carefully designed clinical trials is critical to drug development.The Associate Director , Clinical Trials Communications role within our Research ... vendor invoices and monthly billing packages.Manage/support health literacy and legal/regulatory/ compliance reviews.Serve as liaison with patient advocacy group and… more
- Merck & Co. (Rahway, NJ)
- …recognized internal management consulting team within Medical Operations , driving strategic, large-scale, cross-functional initiatives.Responsibilities:Support the ... initiatives.Expertise in process improvement, enabling technology solutions, organizational design, compliance , change management and other related areas.Excellent communication skills,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improvements and seeks agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement ... About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design and implementation until issue is resolved. Relationships Reports to the Associate Director of Business Applications for Integrated Campaign Management ... About the Department The Finance and Operations dept. brings insights and intelligence to inform...all patient campaign related components and processes to ensure compliance with SOP, audit and industry best practices Physical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and ... Operations team works closely with the business across the...trade analytics. Relationships This position will report to a Director /Sr. Director of Semaglutide Insights & Analytics.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the issue is fixed. Relationships This position reports to Associate Director of Web Technology Platform Development and Operations in Information Technology ... About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and … more
