- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other functions) to implement clinical development plan: study ideation, protocol development, review case report from creation, study initiation, study conduct ... allocation, budget allocation, and assessment of needs including training, data review tools, etc.Standing PRG reviewer for mid-to-late-stage asset protocolsCore… more
- Merck & Co. (Rahway, NJ)
- …methodology across ITLead continuous improvement of the Global IT Quarterly Business Review (QBR) leveraging our OKR methodology and complementary approaches to test ... for ITOversee the overall health of the IT portfolio, including business case support, and managing relevant status in partnership with IT FinanceLeadership and… more
- Merck & Co. (Rahway, NJ)
- …with internal and external reviewers, and guiding the posting through review and approval. Collaborating with clinical teams, including requesting necessary data ... of the European Union). Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated ... coordinates cross-functional regulatory support for development programs and marketed products. Review and provide final approval of local registration study… more
- Merck & Co. (Rahway, NJ)
- …supplier relationships such as: Vendor selection, contract negotiation & review , supplier risk assessments, savings calculations, financial controls, budgeting, ... cost savings and assessing other terms and conditionsProvide business case support for supply decisions based on cost optimizationPrepare,...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard ... on best practices. Author lessons learnt through after action review summaries or other reports to capture knowledge gained....pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …(UAT) scripts and execution, and standard operating procedures (SOPs), and will review and approve related deliverables. In addition, the Systems Coordinator will ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Merck & Co. (Rahway, NJ)
- …problem solve/troubleshoot, with knowledge of root cause analysis.Ability to prepare/ review Standard Operating Procedures (SOP) and cGMP documents.Experience with ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Merck & Co. (Rahway, NJ)
- …Operating within cost and schedule constraints of project and department Peer review across multiple projects Maintaining knowledge of best practices & industry ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Merck & Co. (Rahway, NJ)
- …capability, including strategy and improvement roadmap and the content update, review , approval, and archival process.PMO owner for the training forum; accountable ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Merck & Co. (Rahway, NJ)
- …custom reports and presentations summarizing business and financial data for review by executives, managers, clients, and other stakeholders.--Design and build ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Merck & Co. (Rahway, NJ)
- …for our Biologics pipeline. As part of this role, they will author and review CMC sections of regulatory submissions and associated source technical reports and risk ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date ... of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by… more
- Merck & Co. (Rahway, NJ)
- …submissions for assigned products.- Leading cross-functional teams to develop, review and approve Core and Local Labeling documents.- Recommending strategies ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Merck & Co. (Rahway, NJ)
- …governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of ... expertise in Translational Cardiovascular & Respiratory Medicine CMD Discovery Review core member Represent TMed at core governance (early...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …around processing activities to support reliable operation.Ability to prepare/ review Standard Operating Procedures (SOP) and cGMP documents.Experience with ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …works under supervision to solve complex study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), ... low to medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, data surveillance review ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under some supervision to solve complex study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assessment from a physician's perspective- May provide clinical input into the eCRF ( Case Report Form) design, participate in the UAT (User Acceptance Testing) and ... CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review Plan- Accountable for the assessment of protocol deviations-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams.Develop, implement and maintain SAS programming standards and performs quality checks. Review annotated case report forms and database structures.Develop ... per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management and...reports & graphs in Spotfire for easier data review and visualization. This includes developing programs for patient… more