- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing ... leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the...an integral member of the decision making in the Project lead .ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development ... supporting divisional and departmental level objectives and may also lead a non- project initiative in support of...in a biotech or pharmaceutical company.Demonstrated success as a project manager/ leader in planning and executing strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be defined based on the project needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC Lead on complex and/or ... late-stage project or act as main CMC Lead of an early-stage project . He/she has responsibility for the overall strategy and status of the project with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing ... involves efficient resource management, and clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support in the creation of business cases and the preparation of Kessai and/or Project Entrustment documentation for budget approvals. The Lead will also manage ... rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project . Lead and prepare FDA submissions, including but not ... tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and...the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging technologies and trends in the areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation ... systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal use of resources.- Provide such reports that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary This position leads a team of Global Program & Project Managers for DX projects in specific areas such as Functional Units (R&D, Tech, ... Regional IT projects and optimized PM resource allocation.Responsibilities- Program and Project Delivery PgM/PM Assignment: Assign Program Managers (PgM) and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to ... of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease of review of ... globally. Responsible for representing GRA in the GPT (Global Project Team) as well representing the project ...endorsed by GPT and other governance bodies.Serve as a leader of the GRT (Global Regulatory Team)The primary point… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to ... in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to ... of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …decisions and overcomes challenges using experience and resourcefulness and may lead lower levels in prioritizing and distributing workResponsibilities for the role ... include, but not limited to, the following:Administrative supportCommunicationOffice and Project ManagementContract processing, Agreements, and Payment ManagementProblem-solvingRESPONSIBILITIESAdministrative support: Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Enhance Demand management process in collaboration with DX Strategy and Project and Portfolio ManagementBRM best practices: Research the latest technology trends ... evaluate the success and impact of technology projects, collaborating with Project and Portfolio Management functionChange management support: Assist in change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead respective workstream(s) to gather, document, implement and validate all system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to provide insights and support to the cross-functional GOMA team including TA lead , medical information & education, patient advocacy, and publications, as well as ... medical activities for assigned TA in coordination with GOMA SE lead and other relevant cross-functional stakeholders, and collate for reporting to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally, this position ... skills in working in a fast-paced environment, continuous improvement, project management, change management, and risk management.Responsibilities:Leadership, Direction, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process descriptions and work instructions, particularly for global IT Governance and Project Assurance.- Take on global cross-functional BPM lead functions to ... organization. Responsibilities Process Design, Development, and Optimization:- Coordinate and lead the conception, design, and implementation (process discovery) of… more
