- 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
- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… 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
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre- clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical… 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
- Insmed Incorporated (Bridgewater, NJ)
- …to, the following: Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical ... amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level… 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …to ensure full integration of the device development activities with the clinical , regulatory , formulation, commercial and other key company functions.Represent ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards.Lead/support/oversee clinical supplies production… 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)
- …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
- 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
- Merck & Co. (North Wales, PA)
- … clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director ,...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …understanding of the regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the ... chemical and biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry… more
