- 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)
- …efficiency in execution of project deliverables.-Lead or participate in Engineering Design review sessions.-Ensure that deliverables conform to our Company's ... to progress deliverables.The Associate Director is responsible for leading the planning, design , and implementation of engineering solutions on a suite team within a… more
- Merck & Co. (Rahway, NJ)
- …the strategy, lead activities, and develop a team whose roles include design and development of formulation, manufacturing process, and primary packaging to enable ... development (BPR&D), and Sterile Product Development & Commercialization (SDPC) in the design of new formulations and development of robust and scalable processes… 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
- 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)
- …requests from the business and procurement. Typical Activities : Contract review /negotiations; PO issue resolution; creation of new vendors; supplier issue ... ensure sustainability of the procurement function.Supplier Relationship Management Target : Design , planning and implementation of actions and projects in connection… more
- Merck & Co. (Rahway, NJ)
- …submissions/variations, 510(K)s, CE markings. - Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for ... and teams related to device and combination productsSupport device design control activities and documentation reviewsProvide evaluations of regulatory state… 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
- Merck & Co. (Rahway, NJ)
- …statistical programming activities for Early Oncology clinical development projects. Review the quality and reliability of clinical studies using ... datasets, tables, listings, figures) for early oncology studies.Responsible for design and maintenance of statistical datasets that support multiple stakeholder… 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)
- …team members and global colleagues to implement continuous improvement opportunities, review issues log, develop risk mitigations strategies and ensure all systems ... tools are aligned with the global strategy and support the global design and implementation efforts.- For regional specific needs, implement appropriate processes… 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)
- …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
- 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
- City of New York (New York, NY)
- …Division of Public Buildings, Architecture and Engineering Unit seeks a Senior Design Reviewer (Sustainability) for the Office of Sustainable Design ... for capital projects. The key responsibilities include project scope development, technical review of consultant design documents related to sustainable … more
- City of New York (New York, NY)
- …and Construction, Public Buildings Division, Architecture & Engineering Unit seeks an Electrical Design Reviewer . The duties for this position will include, but ... are not limited to, project scoping, design and/or review of consultant drawings and specifications (utilizing Blue-Beam), site inspection and reports, ad hoc… more
