- Aequor (New York, NY)
- …as an occupational nursing professional Minimum experience of 1-3 years in case management, utilization review and/or quality assurance Experience in episodic ... services to employees within regulated scope of practice and disability case management. Experience/Education: MS/NP in nursing degree and current NP license… more
- 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
- Eisai, Inc (Nutley, NJ)
- …partners to meet assigned timeframes and to assure consistency of case records and documentation.Responsible for evaluating, tracking, documenting and processing ... adverse event reports received for assigned product, including the timely review and distribution to co-marketing partners and Eisai affiliate offices.Evaluates the… 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)
- …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 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
- 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)
- …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)
- …performance oversight and monitoring,Support the Contractor Liaison function through review and approval contractor related investigations, development of contractor ... 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
- 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
- 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)
- …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)
- …in Oncology or Hospital/SpecialtyExperience in company end-to-end medical/legal (Promotional Review Team) review and delivery processes.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)
- …guidance and work with stakeholders to prepare such guidance for review /approval.Identify and promote best practices. Adhere to SOPs, ethics and departmental ... 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)
- …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
- 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
- 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
- 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
