- 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 ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™ lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project ... be limited to, the following: Provide management across multiple studies and clinical operations aspects of gene therapy programs.Responsible for the 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
- Merck & Co. (Rahway, NJ)
- …Software Development, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, Systems Integration, TestingPreferred Skills:Design, Global ... and innovative solutions that enable new SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , you… more
- Insmed Incorporated (Bridgewater, NJ)
- …of new reporting/dashboard system with support from IT and Clinical Systems Lead. Maintains ownership after implementation.Attends relevant external courses ... New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is...Project & Planning Management is a member of the Clinical Business Operations team within Development … more
- 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
- Merck & Co. (Rahway, NJ)
- …risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead ... ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key company functions.Represent Device… 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)
- …execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. ... The Equipment Development and Facility Engineering (EDFE) Leader position will report to the Director , Engineering and will be a member of the EF Team at the Rahway… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required4 or More Years Minimum 5 years' experience with one or more clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. ... milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards.../ GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lock and review of TLG before and after database lock.Ensure DS internal tracking systems are updated (eg Global Project Management System , GPMS). CRO and ... disorders.Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in… more
- Eisai, Inc (Nutley, NJ)
- …to the AD portfolio and continued support as a key partner to Clinical Development, Real World Evidence and Commercial Operations .The incumbent will provide ... If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's Disease, in the… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... include the-development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw… more
- Eisai, Inc (Nutley, NJ)
- …unlawful actions.Oversee system data retention standards and verify system operations .Manage Eisai's information governance program, including JSOX ... Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the...System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information Systems Auditor… more
- Merck & Co. (Rahway, NJ)
- …overall success of the pilot plant. The Facility Lead position reports to the Director of Operations /Head of SSO Pilot Plant and the successful candidate will ... and lead. Track-record of independent problem-solving. Preferred Experience and Skills: Operations experience in a GMP clinical supply facility (intermediate… more
- Insmed Incorporated (Jacksonville, FL)
- …insights to Insmed. Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include trial ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder the guidance of a Senior Director , Outcomes Research (OR), the incumbent will have the primary responsibilities for developing the integrated ... to meet the value evidence needs of payers, health systems , and clinicians. The role involves interactions with HTA...ensure that product value is defined and developed. The Director will also work closely with Product Development Teams,… 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 ... time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs. Has direct supervisory responsibility… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director . The team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS)… more
