- 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)
- …are suitable for both GMP and developmental use. Support the authoring, review , and/or approval of equipment specifications and GMP procedures and documentation, ... 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.--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)
- …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)
- …working with teams to establish project delivery milestones, and oversee the review of deliverables to ensure they meet acceptance criteria, securing sign-off on ... 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)
- …global plans and programs, draft plan documents and amendments and review employee benefit related communications, including annual enrollment materials and summary ... benefits claims/appeals and related litigation Work with internal benefit review committees to respond to severance, savings and pension...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other functions) to implement clinical development plan: study ideation, protocol development, review case report from creation, study initiation, study conduct ... budget allocation, and assessment of needs including training, data review tools, etc. Standing PRG reviewer for...training, data review tools, etc. Standing PRG reviewer for mid-to-late-stage asset protocols Core or extended member… more
- Merck & Co. (Rahway, NJ)
- …quality of clinical supplies to augment and accelerate our products.Author and review GxP documentation including but not limited to batch records, specification, ... 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)
- …negotiations and labor proceedings.Prepare severance agreements.Assist in the development, review and revision of employment policies.Support our Company's HR teams ... 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)
- …Controller, our internal audit team and other functional areas to regularly review and strengthen internal controls for ESG reporting.Effectively develop and work ... 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)
- …context of clinical trials and/or observational studiesProvide guidance, create and/or review dossiers to be submitted to Regulatory Authorities and/or Health ... 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 other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Must be innovative and ... 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
- Eisai, Inc (Nutley, NJ)
- …development and review of SOWs, purchasing, budgeting, and budget review for projectsDevelop business case justifications and cost/benefit analyses for ... spending and initiatives.Develop and implement all policies and procedures, including those for architecture, security, disaster recovery, standards, purchasing, and service provisioning.Negotiate and administer vendor, outsourcer, and consultant contracts and… more
- Daiichi Sankyo, Inc. (Bernards, 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 (IDRP)- Accountable for the assessment of protocol… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assessment from a physician's perspectiveMay provide clinical input into the eCRF ( Case Report Form) design, participate in the UAT (User Acceptance Testing) and ... CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the assessment of protocol deviationsDiscusses… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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. (Bernards, NJ)
- …and inbound sample shipment manifests,and tracking ad hoc shipments in trackers) Review the CRO partner Sample Management Plan, to document cross-functional ... up on the requests/escalation as needed. Process Documentation and ImprovementSupport review of study documents that pertain to biosample collection, handling, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for marketed products and is member of the Product Labelling Committee (PLC) Review Group Review /approve deliverables of the safety surveillance team Safety ... data within allocated product area(s), takes initial actions to mitigate risks in case a safety signal or alert is detected or aggravated and documents the… more
- Sun Pharmaceutical Industries, Inc. (Jamesburg, NJ)
- …PMO representative. This includes proposal development, bid-defense process, and contract review . Act as primary point of contact from clinical operations for ... FPI in a Global or US only study. Budgets- prepare/ review budgets for studies managed in house and ...study documents (ie protocol, Investigator brochure, informed consent document, case reports form etc.) Ensure in-house trial closure after… more
