- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within IT and supports oversight and management of integrations solution design , implementation strategy and requirements gathering, and technical feasibility and ... As a trusted partner, provide oversight of technical and solutions architecture and design for the R&D IT portfolio and ensure that partners receive the highest… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy, design , execution, and interpretation of Oncology clinical trials. Serves as a ... a physician's perspectiveMay provide clinical input into the eCRF (Case Report Form) design , participate in the UAT (User Acceptance Testing) and CCG (CRF Completion… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mitigating potential risks. Implementation of new CSPV SystemsResponsible for ensuring the design of the CSPV solution that satisfies the business process visionLead ... platforms and systems design and optimization to deliver best-in-class solutions Change Requests...operating modelDrive key project deliverables, including requirements definition, process design , solution design , test planning and execution,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary Position leads complex studies in study design , statistical analysis and interpretation of results with some supervision. This ... report (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review, SAP development, analysis files development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …effective transformation and automation across the organization. Responsibilities Process Design , Development, and Optimization:- Coordinate and lead the conception, ... design , and implementation (process discovery) of cross-functional end-to-end processes.-...leading of cross-functional and global projects, ideally in process-oriented design and implementation projects in the area of Business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …report (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review, SAP development, analysis files development, ... college or university) Summary: Position leads complex studies in study design , statistical analysis and interpretation of results with some supervision. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and Central ... Monitoring.Responsibilities:CRA Monitoring Oversight Management:Support monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures, and the development and execution of monitoring activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in internal and external cross-functional meetings or other relevant activities.Quality by Design (QbD) and Continuous Improvement: Provide support to the BPQLs and ... GQLs by reviewing and providing input during the development and implementation of Protocol (study level) and Global and Local policies and procedures (system level).Provide guidance, with oversight by RD Quality team members, during the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and meet increasing project demands. Program Management: Guide Program Managers to design and charter programs to efficiently plan, execute, and manage a group ... of interdependent projects to realize overall program benefits in alignment with the organization's strategic objectives. Lead PgMs and PMs to manage the delivery of approved IT programs and projects ensuring the quality of PM activities including:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical Affairs stakeholders on assigned TA educational grants and/or sponsorships- Design and implement internal communication plans to share educational and ... project outcomes metrics for the assigned therapeutic area(s)- As needed, in alignment with the Analyst Operations team/delegate, perform operational duties (ie collecting and triaging grant submissions, organizing submissions to the Programs Grants Committee,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills, is well organized, and an outstanding collaborator.Responsibilities- Perform service- design responsibilities for projects and major changes, participate in ... RFP-related activities/reviews.- Partner with application teams and vendors, when appropriate, to deliver projects. Partner with other IT leaders across the organization and champion the day-to-day operation of the lifecycle of Incident, Problem, and Change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications solutions implementation teams (including external vendors) in the design , development, implementation, validation, roll-out, training and support of ... global and regional DS applications to meet business needs using a standard methodology. Oversee applications support groups' system validation and change control process. Collaborate with the Services organization to ensure smooth transition from system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge management tools. Closely partners with senior Business stakeholders to design optimal processes and sourcing solutions that meet the business' objectives ... and produce synergies for Daiichi Sankyo. Demonstrates leadership skills. Is highly experienced and comfortable leading complex initiatives and negotiations of high dollar value from inception through to implementation. Leads collaborations with all required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in an ICF FAQs document used by the Biosample Management team to design informed consent forms for future studies-Present the findings to relevant stakeholders to ... highlight some of the differences in permitted biosample and data use from various countries Education/Experience: Interest in learning more about clinical trialsAbility to extrapolate key information from complex documentsExperience with Excel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with various communication-based tasks supporting Global R&D helping write, design , and create visual content (eg, videos, PowerPoints, infographics); assisting ... efforts to define, develop, manage, and execute communications strategies; assist in planning, writing, and managing key message documents and talking points for key spokespeople in Global R&D research and collaborate with staff on best practices, new ideas,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …approximately 37.5 hours per week. Responsibilities: They will be accountable for Design data structure to connect discrete and non-discrete manufacturing data from ... internal manufacturing sites across the globe Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education/Experience: Rising seniorFamiliar with Microsoft Office, Power BI, Tableau,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …adoption of citizen development. This position will participate in process discovery & design sessions with business members, Cit Dev training & help sessions, aid ... in the creation of automation documentation, and assist with managing the regional automation intake process/pipeline. Education/Experience: Qualified candidates must currently be enrolled in an accredited undergraduate or graduate program with a concentration… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …will be able to contribute to developing in vivo cell therapy platform through vector design , in vitro function assay, and assay development of virus PK and PD in ... cell and gene therapy platform and optimize cell-based immunoassays, including vector design , VLP design , virus packaging and titering, immune cell isolation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for facilities engineering support, design , and implementation for mechanical systems and equipment, and work order ... programs for engineering driven initiatives. Serves as SME on engineering design projects; sets project requirements, evaluates compliance with project and… more
