- Merck & Co. (Rahway, NJ)
- …Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our company's Device ... & Process Development (DPPD) Team, which focuses on the design , development, and commercialization of novel biologic/drug/vaccine-device combination products for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and participation in QA initiatives.Partner and ... continuous process improvement activities within QA, as necessary.Participate as a Quality Reviewer for Health Authority inspections in the US, in collaboration with… more
- Merck & Co. (Rahway, NJ)
- …with SAP Authorizations Design and Support.Experience in supporting SAP User Access Review and in SAP SOD and Ruleset Design and support also required.Must ... you will play a pivotal role provide support for SAP authorization strategy, design and execution in both production and non-production SAP systems.What will you do… more
- Merck & Co. (Rahway, NJ)
- …This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and ... design control and risk management techniques to positively support...risks within our Company and with external suppliersAuthor and review relevant portions of the regulatory submissions (INDs, IMPDs,… more
- Merck & Co. (Rahway, NJ)
- …of biomarker flow cytometry assays from Preclinical Research to Clinical Development. Design , develop, and optimize flow cytometric assays across all therapeutic ... the development, validation, and execution of flow cytometry assays.Draft and review Statements of Work (SOWs), Workplans, Development Testing Agreements (DTAs), and… more
- Merck & Co. (Rahway, NJ)
- …or custom reports and presentations summarizing business and financial data for review by executives, managers, clients, and other stakeholders.- Design and build ... on large and disparate datasets, specifically: Modelling and analytics: Design of Experiments, Time Series, Regression methods.Data Mining, Predictive Modelling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support the Company's vision including elements to achieve a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. ... functions globally and with external parties as required.Champions 'Quality by Design ' and Quality Risk Management approaches to quality management within Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Plan (IDRP)Accountable for the assessment of protocol deviationsDiscusses medical… more
- Merck & Co. (Rahway, NJ)
- …responsible for some or all of the following core activities:Case review /approval for assigned productsExpedited case submission according to timelines outlined in ... clinical study dataParticipation in risk communication planningParticipation in the design and/or fulfillment of supplementary monitoring activitiesDevelopment of risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …users to roles based on authorized requests from study team members, periodic review of user access and audit trail reconciliation, impact analysis and documentation ... and maintain traceability of data access requests, procedures for the periodic review , and process improvements. This position will also work with members of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study report (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review , SAP development, analysis files ... diseases and immune disorders. Summary Position leads complex studies in study design , statistical analysis and interpretation of results with some supervision. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with ... strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list for study.Study Planning: Contributes to clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process optimization to deliver measurable results through the engagement in design and develop methodologies, pursuing the implementation of projects and monitoring ... agent to promote a culture of continuous improvement and quality awareness. Design , deliver and implement training programs worldwide to enhance employee engagement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level. Responsible for clinical program planning and execution (from study design , operational planning, start-up, conduct, reporting, and close out) including ... develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data ... data and programming standards; emerging data capabilities and methods. Implements quality-by- design approaches to confirm the quality, integrity, and fit-for-use of… more
- City of New York (New York, NY)
- …Department of Design & Construction, Public Buildings Division seeks a Sr. Design Reviewer to join the Sustainability Unit. The selected candidate will serve ... sustainability and resiliency; LEED compliance strategies; and certification documentation. The Sr. Design Reviewer will also be responsible for energy master… more
- City of New York (New York, NY)
- …of Public Buildings, Architecture and Engineering Unit seeks a Senior Design Reviewer (Mechanical) experienced in heating, ventilating, air conditioning, ... for project scope development; existing conditions surveys and forensic analysis; the review of design and construction documents prepared by consultants; the… more
- City of New York (New York, NY)
- …Division of Public Buildings, Architecture and Engineering Unit seeks a Senior Design Reviewer (Electrical). Reporting to the Director and Deputy Directors ... for project scope development; existing conditions surveys and forensic analyses; the review of design and construction documents prepared by consultants; the… more
- City of New York (New York, NY)
- …Division of Public Buildings, Architecture and Engineering Unit seeks a Senior Design Reviewer (Civil/ Geotechnical). Reporting to the Director and Deputy ... for project scope development; existing conditions surveys and forensic analyses; the review of design and construction documents prepared by consultants… more
