- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. ... of 7 years of experience required Experience Qualifications.7 or More Years 7 years clinical operations experience in trial diversity and patient access and/or … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial ... on CRO/Vendor oversight standard practices across GCO and work with Global Clinical Operations , as needed, to understand business priorities.Develop and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... of 7 years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry setting. required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work closely with cross-functional project teams, including Clinical Development, Clinical Operations , Biometrics, and Regulatory Affairs personnel to ... development and regulatory requirements of a clinical program. The Director will provide high...Writing team. Essential Functions Provides strategic input to support clinical operations and regulatory submissions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will ... plus. required Experience QualificationsStrong experience and expertise in end-to-end clinical operations functional understanding and execution, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OED; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes ... Collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations , Data Management, Scientific Operations etc) and ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …shape decisions and drive organizational action, guide the Business units and the Clinical , Medical, and Regulatory Affairs (CMR) teams on strategy development ... About the Department The Finance and Operations dept. brings insights and intelligence to inform...eight (8) years of relevant experience required Experience in Clinical , Medical, Regulatory or Research and Development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Manager, Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... status. In addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry...including experience in one or more key functions (eg, clinical research, clinical operations , data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or several programs.Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and other RD ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory requirements Work with the VP Medical/Scientific Development, Clinical Operations , Non- Clinical Research, Medical Writing, Program ... Vice President, Medical & Science. Work with the VP Medical/Scientific Development, Clinical Operations , Non- Clinical Research, Medical Writing, Program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Catalent (New York, NY)
- Account Director , Biologics Drug Substance Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative ... Industry experience with a technical sales focus, or 5+ biologics drug substance operations experience and 1 or more years of technical sales or commercial … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and ... and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management,...biotechnology experience in one or more key functions (eg clinical operations , clinical research, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key roles in Global DX / GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption of metrics. Act as a ... Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog along with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure ... sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... of clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs, and Regulatory Affairs (CMR), staying… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA...Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs… more
