- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and members of the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology development and ... portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs activities. Represent Medical Affairs in new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase ... or US based Global Function leaders as a Finance Business Partner.Provides guidance to them during the annual and...I-III clinical studies.Partner with Project Management, Clinical Operations and other functional groups to ensure budgets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development , Research Development , Regulatory Affairs. Facilitate ... areas centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory ... direction and serves as a knowledge source for Informatics on systems development .Responsibilities- Provide the interface between the business and the technology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... the development and maintenance of the CCDS, US and EU...(HA) regulations and guidelines, internal company procedures and company business objectives. This position manages new projects and projects… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …highest level of qualityCollaborate with internal stakeholders - including IT and business resources, contracts, and procurement - to develop criteria and best ... for ensuring the design of the CSPV solution that satisfies the business process visionLead platforms and systems design and optimization to deliver best-in-class… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … informatics tools Drives the development and delivery of innovative clinical informatics solutions and services response to business requirements and ... you ready to make a difference? The Position The Director , Clinical Informatics in the Clinical...Clinical Data Science & Evidence (CDSE) department develops clinical and medical informatics software and system development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible PED champion ... method review) Facilitates integration of the US PED strategy into clinical development programs, post-authorization and commercial research activities and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Data Science & Evidence (CDSE) department of NNI focused on clinical informatics tools development to support the CMR organization. This individual ... will serve as a subject matter expect on clinical and medical informatics software and system development...measurements that are consistent with the priorities of the business , and that interim reviews are held so that… more
- Genmab (Plainsboro, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a… more
- Genmab (Plainsboro, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks Creatively advise on the development of product ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Genmab (Plainsboro, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... this role, the regulatory leader will be primarily responsible for the development of global (and US) regulatory strategies (depending on the assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trial managers and CSLs, who contribute to the planning, conduct and reporting of clinical trials. Ensures business needs are met through alignment of ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business… more
- Genmab (Plainsboro, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in...a pivotal role in managing the relationships with the clinical vendors as well as coordinate and manage outsourcing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance, Insights & Enterprise Solutions ... maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will have the opportunity to build… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs Develop and implement ... will provide valuable support and consultation to Senior Leaders in the Line of Business . In this role, the Director will demonstrate exceptional ability to… more
