- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management .Responsibilities:ICSR Processing: Oversees QC activities, ... handles escalated global CSPV case processing issue and handles project . This position prepares trainings, supports CAPA investigations, case...supports projects and interacts with the DSI Case Management team / global case management team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell and gene therapy cell starting materials and/or manufacturing processes.Provide project management , purchasing, shipping, and invoice review support for ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Director , Global Sourcing (Direct Materials) as part of the Technical Operations team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Director Commercial Innovation drives commercial innovation with a specific focus on the obesity ... mitigate risks before scaling initiatives. Relationships Reports to the Executive Director of Strategic Operations. This position interacts with senior leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required Deals with concepts and complexity comfortably Excellent administrative, organizational, project management and analytical skills Experience managing ... to develop the ongoing relationship with GBS. Relationships The Associate Director interacts regularly with the Enterprise Insights LT, Strategic Advisors across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …label negotiations and ensures optimal label for pipeline assets Responsible for project management and coordination including overall ownership of launch ... lives of more patients than ever before. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has overall strategic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other departments to ... be supporting early clinical safety for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections. Finally, this position has advanced skills in continuous improvement, project management , change management , and risk ... disorders. Job Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data management strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred Experience Qualifications 7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or Pharmaceutical ... The qualified candidate will provide knowledge-based coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe purpose of the Senior Director , Forecasting & Business Analytics is to lead the forecasting and financial ... valuations in order to provide strategic guidance to senior management , support commercial and strategic decision making.ResponsibilitiesRevenue Forecasting - Owns… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for AI/Data Scientists as needed for exploration, experimentation, or new development Project & Change Management Experienced in managing multiple teams and ... with and manages various vendors. Essential Functions Leadership and Management Skilled communicator and collaborator with influence across functions Strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, ... research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization ... to MA activities for internal QA team (global/ local), but also to:Global Project TeamsGOMA and Specialty MA Management teamsData Management / Biostats… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … and Training functionsMust have proven people leadership experience.Must have demonstrated project management skills and experience working on global projects ... Overall accountability is develop strategic framework work for GxP document management and GxP training across DS group including business units, functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and procedures.Conduct other projects as assigned within, or by, Global Project Management & Leadership group.Qualifications: Successful candidates will be ... GDP training, GPM&L Project Review Meeting, GPM&L Staff Meeting, GPM&L Records Management Training, etc. Prepare agenda and assist in management of monthly… 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)
- …Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates ... the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation 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 ... Biostatistics Data Management & Data Ops for EDC, edit checks, data...for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs and Federal ... to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs. Develop and maintain positive rapport and working… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …think creatively to solve Outstanding team- and client-facing communication skills Project management skills Quantitative analysis skills Statistical programming ... need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential?… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …think creatively to solve Outstanding team- and client-facing communication skills Project management skills Quantitative analysis skills Statistical programming ... us? The Position The Senior Manager - Market Access Insights works with the Director - Market Access Insights to explore key market access topics of interest and… more
