- 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)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The AD will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange ... process improvements.Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidenceReview of Change… 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 ... managed elsewhere internally or at vendors. Relationships Reports to the Senior Director , Advanced Analytics & Innovation. Works closely across the entire NNI… 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 ... Are you ready to maximize your potential with us? The Position The Associate Director , Data & Analytics Governance is responsible for the governance of NNI data… 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 ... in order to accomplish objectives. Relationships Reports to the Executive Director , Patient Support Solutions. Key internal relationships include brand marketing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an ... to Senior Leaders in the Line of Business. In this role, the Director will demonstrate exceptional ability to proactively partner with and appropriately influence… more
- Genmab (Plainsboro, NJ)
- …fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse ... as well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.Participate in global ... product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for… 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 ... accordance with IFRS regulations. Relationships Reports to the Associate Director of Accounting at Novo Nordisk Inc. As part...monthly status reports on closing process to the Associate Director of Accounting, the Senior Director of… 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 ... such as Corporate Procurement, Global Legal Operations, NNI DD&IT, Legal, Privacy, Safety and line of business (LOB) leaders, and manage external relationships with… 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 ... other Managers within Strategic Pricing. Provides periodic analytical analysis to the Director , Pricing & Market Access Insights. The position will interact with a… 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 ... plans and contests supported by incentive compensation. Relationships Reports to Director - Field Force Incentives and Communications. Internal relationships include… 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 ... seek agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement Team and will interact with all… 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 ... to unstructured problems with minimal guidance. Relationships Reports to Director , Obesity Insights & Analytics. Internal relationships include interactions with… more
