- 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)
- …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 ... Management, Stakeholder Relationship ManagementPreferred Skills:Business Analysis, Business Analysis, Business Case Analyses, Business Case Development, Business Data… 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)
- …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
- 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)
- …by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations.Ensures permanent audit readiness, ... and monitoring, effective complaint management, change control oversight, metric review , and review of annual product reviews....pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …partnership with the CTT.-Collectively and periodically (eg quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify ... Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners...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.--Deep comprehension of ... 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 human through line of sight to commercial productionOversee and review CMC authoring activities for DP manufacturingEnsure successful and effective technology ... 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)
- …the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, ... 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)
- …and support of ancillary agreement creation, such as regulatory agreements.- Review project details, update and track business development related communications ... 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)
- …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)
- …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)
- …program-specific design controls process and design history file development.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, ... 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)
- …business. Accountable for establishing a Safe by Choice.- Accountable to review and approve compliance documents, as per procedures or need.Continuous Improvement ... 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)
- …broad guidance of the digital CMC & Development and Commercialization Review Committee (DCRC) Steering Committee and Executive Sponsors, Digital manufacturing CMC ... 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
