- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Learning & Development role will design and develop engaging, ... bring learning to life in the flow of work. The Manager , Learning & Development will collaborate with stakeholders across the organization, leveraging data,… more
- Merck & Co. (Rahway, NJ)
- …DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities ... but not limited to: data management tool and system development , validation and maintenance, data integrity review and reconciliation,...limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety Scientist Product Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed ... preferred Experience Qualifications - Possesses scientific or therapeutic area, and drug development knowledge preferred - 0-1 year of experience with an advanced… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... Vendors for the data services they provide to support drug development processes and global submissions.This position provides expertise within Data Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The primary responsibilities of the Manager , Omnichannel Marketing is to support the development , planning and ... customer segments across the portfolio in partnership with brand teams. The Manager should assess external digital opportunities and threats, customer journeys, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... requirements into technical specifications and data models to guide the development of reporting and analytics solutionsUtilize fit-for-purpose analytics tools and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents ... under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... scalable approaches for data quality issue identification, support mitigation, the development and implementation of data quality standards and data protection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Sankyo oncology medicines.Responsibilities - Support planning and managing the development and execution of pre-launch, launch and post-launch corporate ... or More Years Experience direct responsibility for external/internal communications content development and strategy support required- 1 or More Years Experience in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards in all GOMA clinical operational activities. Support the development of clinical operations related to Corrective and Preventative Action (CAPA) ... plans for issues of non-compliance if applicable. Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university) Bachelor's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and quality. Responsibilities include: contribute to CRF and SDTM standard development , support develop, implement, and maintain Analysis Data Model (ADaM) dataset ... reporting of clinical trials. preferred- Having knowledge of all phases of drug development , including early and late phase clinical development and submission… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for reporting to ensure quality and compliance in safety reporting.Procedure Development : Supports the process redesign activities to ensure compliance and ... more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …understanding of Health Authority expectations in the areas of Pharma Development ; preferably working in a GxP regulated environment, pharmaceutical industry.- ... Training and curricula development experience including oversight and administration of validated electronic systems such as LMS or other quality management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to ... analyses of historical data and assist in designing initiatives and development of analytical capabilities and dashboards needed for short- and long-term… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Primary support of the Global R&D organization, Global Business Development and other corporate functions.Responsibilities- Legally and ethically help monitor, ... intelligence functions to continually learn and inspire others in the spirit of development and growth, and share and build on Competitive Intelligence expertise and… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...for clinical studies. As the statistical lead for biomarker development , this individual primarily will be accountable for the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... program.- Develops and manages project plans which span from protocol development through database lock, archiving, and submission deliverables where applicable.-… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... we want to hear from you. Job Summary The Manager , Corporate Planning & Strategy will report directly to...between HQ and Americas Region. Responsible for monthly report development , Quarterly Board of Director Committee material development… more
