- 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regulatory submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, ... guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis...identify data inconsistencies and support data review , review analysis dataset specifications and ensure… 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)
- …under some supervision to solve complex study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and managing a learning program from content to delivery. ** Prior to applying, review the Education & Qualification section - Be sure you possess the Minimum years ... project kick-off decks, project status updates, executive summaries and case studies, and document client meetings. Qualifications: Successful candidates will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners ... forums, workshops and training on new guidances, regulations to enterpriseSharing case studies with enterprise Qualifications: Successful candidates will be able to… more
- 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 in… more
- Insmed Incorporated (Bridgewater, NJ)
- …from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of ... eg MACE, Potential events related to metabolite, Liver enzymes. Review of mortality cases, evaluation of CIOMS, production of...with PIs in each reported SUSAR to understand the case assessment. Production of initial narrative to understand each… 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)
- …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)
- …and participate in team presentations associated with any financial and/or operational review with client areas being supported, including the Late Development ... Review Committee.Support project team decision making by providing relevant...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …with those of allied domains, and coordinate rollout and adoption strategies. Review requirements and architecture to ensure the selection of appropriate technology ... users.Strong analytical and problem-solving abilities, applying SRE practices to review requirements and architecture for optimal technology selection and resource… 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)
- …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)
- …for quality oversight cleaning and thermal validation.Responsible for the review and approval of SOPs.Provide Quality support for Environmental Area ... 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)
- …systems.Evaluation and design of interfaces between SAP R/3 and external systems. Review and implement the recommendations of SAP EarlyWatch Reports.Strong 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)
- …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
