- Merck & Co. (Rahway, NJ)
- …Documentation Practices (GDP) is required, as the successful candidate will be a reviewer and approver.- Regular feedback and coaching is a part of this position ... 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. (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- Accountable for the assessment of protocol deviations-… 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. 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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …Process Guidelines. You will have the opportunity to lead and participate in the review of electronic case report forms (eCRF) and edit checks, database ... 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)
- …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)
- …Risk Management leads to determine the data relationships and mapping.Lead data review meetings with content owners and Quality.Create and manage data linkages and ... from concept, launch and post market. -Support second person review with source data for regulatory filing.Support Design Transfer...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 for all submissions and associated documentation. ... approval according to the committee charters (including therapeutic area Document Review Committees, Product Development Team, Early Development Team, and label… more
- Merck & Co. (Rahway, NJ)
- …policies.Responsible for managing all external requests for clinical data.- Periodic review of metrics and identification of process improvement needsResponsible for ... global disclosure requirements, data access and all voluntary company policies. Review and approve local country disclosure SOP's to ensure...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …customer resources, and lead approval of resources through the Promotional Review Team (PRT) process.Engage effectively with regions and marketsProvide leadership, ... 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)
- …Primary Activities include, but are not limited to: Supporting the preparation, review , and approval of documentation related to validation and quality operation of ... solutions. As part of this Quality Unit (QU) role, review and approve ERP changes. Work in dynamic environment...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations) Review and approval of data and technical documentsAbility to recruit, select, ... and other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Exposure to project /… more
- Merck & Co. (Rahway, NJ)
- …engineers by coaching and developing for success through feedback and development guidance. Review and approve GxP documentation including but not limited to batch ... 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
- Merck & Co. (Rahway, NJ)
- …labs in analytical method validation and transfer activitiesMaintain timelines; manage review and approval of validation and transfer protocols and reports; assist ... 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)
- …complex retention-based systemsAdvanced experience in various migration projectsAbility to review SIT scenarios to ensure the proposed SIT scripts encompass ... 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)
- …compliance audits, inspection activities, and investigation/CAPAs . Author and review technical documentation including regulatory submissions. - Advance strategic ... 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
