- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... Strong knowledge of ICH-GCP relating to regulatory guidelines, and quality management principles. requiredExpert knowledge in Clinical Operations Phase 1 to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and ... within the Commercial and IMP Release Program which include management of product release programs, deviation investigation programs, standards development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of professional pharmaceutical industry experience required- Proven expertise in project management required- Strong knowledge of patient safety and ... diseases and immune disorders. SummaryThis position is responsible for supporting project management and operational activities as part of the Project Management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working knowledge… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure drug destruction process and other study close out activities are completed. Knowledge Management : Support Department in codifying existing knowledge ... International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety ... (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product management ) or equivalent preferredOncology and/or Rare Disease therapeutic knowledge preferredLifting & transporting training materials up to 70 lbs 5% ... other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... as well as building a network with key staff members including senior management , the global functional leads, Regulatory Intelligence, and Policy and company trade… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology compounds and support building up oncology programming ... timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- 4 or More Years 5+ years in meeting planning or technology project management required- Strong knowledge of Cvent or other meeting management ... efficiency, and deliver exceptional meeting experiences.Vendor Relations and Contract Management - Develop and nurture relationships with vendors and suppliers-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …theories, and/or methodologies associated with the professional disciplines, as outlined in Data Management Body of Knowledge (DMBOK2) required- 4 or More Years ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas...will work in areas required for the good day-to-day management of data at Daiichi Sankyo including: the stewardship… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective communication ... measure key success factors.- Drive continuous improvement and maintain current knowledge of cGMP regulatory issues, Good Automated Manufacturing Practices (GAMP5)… more
- Merck & Co. (Rahway, NJ)
- …the world. Here, you have that opportunity. You can put your integrity, knowledge , imagination, skill, and teamwork to work in collaboration with a diverse group ... making your impact today. -Overview: Global Project and Alliance Management (GPAM) sits in the research & development organization...unmatched opportunity to build your career as a project manager in a highly complex and important field. You… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis or consulting experience. required- Prior work experience as a top tier management consultant, project and change manager or similar role in ... global needs for Daiichi Sankyo. Will lead project and change management for complex, cross-functional initiatives for global teams and workstreams, ensuring… more
- Merck & Co. (Rahway, NJ)
- …and ability to work within these guidelinesExpertise in and excellent working knowledge of core trial management systems and tools Behavioral Competency ... the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person is responsible to manage...Conference on Harmonization Good Clinical Practice (ICH GCP.)As line manager , the role is critical to continuously develop key… more
- Merck & Co. (Rahway, NJ)
- …the world. Here, you have that opportunity. You can put your integrity, knowledge , imagination, skill, and teamwork to work in collaboration with a diverse group ... Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO organization. GDO...the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing… more
- Merck & Co. (Rahway, NJ)
- …the world. Here, you have that opportunity. You can put your integrity, knowledge , imagination, skill, and teamwork to work in collaboration with a diverse group ... of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the planning, execution and… more
- Merck & Co. (Rahway, NJ)
- …Safety, Process Development, Technical Services, Utilities and Validation.-The Project Design Manager (PDM) Associate Director will lead project teams thru the ... Front-End Loading Project Design Management Process reporting to the GES Technology Center Design...of design specification development, schedule and resource planning, and knowledge of Biologic, Sterile Vaccine equipment design and capital… more
- Merck & Co. (Rahway, NJ)
- …to facilitate problem resolution and ensure project success.-Experience with change management and leading process improvement initiatives.-Strong knowledge of ... the world. Here, you have that opportunity. You can put your integrity, knowledge , imagination, skill, and teamwork to work in collaboration with a diverse group… more
- Merck & Co. (Rahway, NJ)
- …a Release Manager with experience in coordinating and managing releases, knowledge of relevant tools, process and technologies, a strong understanding of the ... collaboration skills, and a focus on quality and customer satisfaction.The Release Manager is responsible for the planning, coordination, and execution of software… more
