- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy, design , execution, and interpretation of Oncology clinical trials. Serves as a ... 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… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and Central ... study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to… 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)
- …Daiichi Sankyo's mission by leading conversations across functional teams (ie Grant Review Committees) around the grant and/or project decisions that meet the ... Internal Strategy and Operations- In alignment with senior colleagues, collect, review , and make decisions in collaboration with relevant Medical Affairs… 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 ... immune disorders. Responsibilities:- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Merck & Co. (Rahway, NJ)
- …capture knowledge gained.Drive new technology development projects through participation in equipment design and testing as well as preparation, review , and ... for and support batch processing readiness and execution activities.Prepare, review , and/or approve GMP Documentation as appropriate.Author/Approve Standard Operating… more
- Merck & Co. (Rahway, NJ)
- …knowledge gained. Drive new technology development projects through participation in equipment design and testing as well as preparation, review , and completion ... and support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard Operating… 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
- 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 ... tools for subcutaneous biologics absorptionDemonstrated leadership skills and organization design (ie building high performing teams, building talent, and shown… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills, is well organized, and an outstanding collaborator.Responsibilities- Perform service- design responsibilities for projects and major changes, participate in ... leadership, and external vendors/partners to execute responsibilities.- Responsible for review , approvals, categorizing, prioritizing, of change requests.- Analyze Service… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …time or position works for approximately 37.5 hours per week. Responsibilities: - Review clinical study informed consent forms (Master, country and site level) and ... in an ICF FAQs document used by the Biosample Management team to design informed consent forms for future studies-Present the findings to relevant stakeholders to… more
- Eclaro (Short Hills, NJ)
- …Required Qualifications: Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation. Ability to work ... with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace… more
- Eclaro (Chinatown, NY)
- …Review and integrate all application requirements into Architecture design , including functional, security, integration, performance, quality, and operational ... to the business case. They will also provide consulting during the detailed design , build, test, and deploy phases, and reengaged to perform benefits realization.… more
- Eclaro (Edison, NJ)
- …protocols, reports, risk assessments, and MBRs. Provides assistance to sites to review /resolve quality events as needed. Collaborate on TT project definition and ... other functions Desired Skills: Thorough knowledge of quality systems, Quality by Design , validation principles for product and engineering design and process… 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)
- …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
