- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of ... the Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global DBMA quality standards for Change requests- IT Vendor Oversight and Management . Managing CSPV IT Budget for Local DSI CSPV Systems Monitoring disruptions ... by a deep understanding of the current operating modelDrive key project deliverables, including requirements definition, process design, solution design, test… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry (preferably in a global company).10+ years of expertise in project management , process, product, and/or analytical development activities and ... Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for...at least 2+ years in a direct or matrix management position of a CMC-related function in the pharmaceutical/biopharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have the expertise and leadership to manage ... around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position...business acumen who is skilled at both program and project management . This role is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Demand management process in collaboration with DX Strategy and Project and Portfolio ManagementBRM best practices: Research the latest technology trends and ... KPIs to evaluate the success and impact of technology projects, collaborating with Project and Portfolio Management functionChange management support: Assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …priorities. Will be expected to serve as the lead with the vendor & project management requirements for initiative completion. They will lead the search for ... areas centered around rare diseases and immune disorders. Summary: The Associate Director , Commercial Training Lead, Oncology will be accountable to lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ability to combine attention to detail with big picture perspective preferredStrong project management skills, experience leading projects/teams and ability to ... Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy: Provides the strategic direction to ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to review all congress initiatives, timelines and deadlines for content and execution. Project management to ensure all business-critical deadlines are met for ... areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 comments ... Core Data Sheets, EU and US Documentation: As the project lead, Independently or through direction of a team...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …priorities simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product, and/or analytical development activities and ... respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading ... plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and may collaborate with team on CAPAs, including CAPA responses and approvals Project Management :Collaborates with the PSL(s) to proactively plan and prioritize ... to efficiently evaluate safety is desirable.Microsoft Word, Excel, PowerPoint skills, and Project management skillsAble to work independently with minimal direct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to define problem statements and provide efficient solutions. required- Demonstrated project /program management experience required- Certification in one or more ... as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross-regional senior leaders with collaborative mindset required- Prior experience in project management or leading change management initiatives ... disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leads all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing ... by the Business and the utilization of suppliers.- Serve as the Project Management Owner for DSI's overall Supplier Relationship Management Program (SRM)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …R&D), Global Commercial & Strategy, Global Forecasting & Insights and Global Project Management . Successful execution will involve working cross-functionally to ... including managing the interface with global/regional teams and ensuring alignment with project assumptions.- Collaborate and set stage with the wider GBD team to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… more
