- Merck & Co. (Rahway, NJ)
- …is this job), Development, and CMC; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and Administrative Professionals. - - ... . - Under the broad guidance of the Executive Director , GPAM, the core responsibility of this Value and...staff manager will be expected to monitor quality of project management deliverables and assign accountability for… more
- 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
- 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)
- …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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …department, focusing on e-Billing operations or law firm equivalent (pricing, analytics, project management , etc.) Demonstrated track record of running and ... tools (eg, MS Excel, Power BI, Tableau, Cognos) and report automation preferred. Project management experience leading large-scale projects, ideally in a legal… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Guidelines, Pharmaceutical Research, Policy Development, Product Commercialization, Project Leadership, Project Procurement Management , ... contractors including Good Manufacturing Practice (GMP) qualification as well as site/ project selection.Additionally, the incumbent would serve as the bridge between… more
- Merck & Co. (Rahway, NJ)
- …market eventsExcellent interpersonal, analytical, strategic, and tactical planning, project management , communication, and organization skillsExceptional ability ... contentCommitment to keeping team members, departmental colleagues (as appropriate), and management fully apprised of project /initiative status and issuesProven… more
- Merck & Co. (Rahway, NJ)
- …As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing ... Controls and Device Supplier Management objectives and build QMS capabilities that touch every...aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with cross-function teams to… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Director , Advanced and Omnichannel Analytics will be a member of the Business Intelligence team ... innovative approaches to enhance the effectiveness of our current analytics.The Director , Advanced & Omnichannel Analytics will collaborate with Marketing Insights,… more
- Eisai, Inc (Nutley, NJ)
- …stakeholder management , vendor management , budget planning & resource management .Demonstrated track record as Study Director (or equivalent role) with ... If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive … more
- Merck & Co. (Rahway, NJ)
- …digital tools. Must be skilled in Power Platform.Strong analytical skills, project management and facilitation skills required.NOTICE FOR INTERNAL APPLICANTSIn ... and accelerates future talent for the division. The Associate Director , Alliance Management is responsible for managing multiple aspects of the Manufacturing… more
