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for legacy/new sites aligning with stakeholders - Provide CAPEX estimation based on the layouts and historical data to support... and conduct value engineering/ value analysis - Ensures projects are executed in adherence to all Environment, Health & Safety... Apply Now

試験開始前の治験薬概要書や国外の新薬臨床試験開始申請に対するDGA(Data Gap Analysis) ・承認申請書作成(CMC部分) ・GCTP適合性調査対応支援 ・承認申請後の規制当局(PMDA、FDA等)照会事項対応・相談対応 ・カルタヘナ法に係る申請 ■魅力点： ・遺伝... Apply Now

ダーコントロールも行っていただきます。 ■業務内容詳細： ・CTD(2.3、3などCMCパート)作成 -治験開始届出用DGA／臨床試験開始前の治験薬概要書や国外の新薬臨床試験開始申請に対するDGA(Data Gap Analysis) ・承認申請書作成(CMC部分... Apply Now

data analysis using various analysis tools such as Exensio and JMP Excellent communication skills, writing... targets and specifications in each process. Analyze yield data, identify root causes, and promote improvement activities... Apply Now

Application (NDA) submission timeline. Develops clinical data package, designs local/regional studies or selects Global studies... constituting the clinical data package. Responsibilities in Global study Reviews study plan and design [i.e. Protocol Element... Apply Now

across internal/external groups. Provide meaningful statistical data analysis, analytics and justification on program validation... in product data sheets. RESPONSIBILITIES AND TASKS: Independency of development of new tests and test algorithms... Apply Now

Analysis Plan (SAP)/Data Presentation Specification (DPS), Japanese translated IB and ICF, IDMC charter (if necessary... and/or Diagnosis Committee if needed O Reviews study related documents including Statistical Analysis Plan (SAP)/Data Presentation... Apply Now

data from traffic analysis tools and system audits. Familiarity with supply chain security and vendor risk management... and methodologies for threat detection, network traffic analysis. Your expertise in security frameworks (e.g., NIST, ISO 27001... Apply Now

languages for data analysis or simulation (Ex. Python, Matlab, C/C++) Experience with CAD software for 3D modeling and drafting... their best at work. We are seeking an energetic and highly motivated Optics Design Analysis Engineer to work on design analysis, DFM... Apply Now

knowledge and data-driven insights - Develop and implement best practices for client servicing including relationship... management, product suite education and enablement, business reviews, reporting and analysis - Work closely with client... Apply Now