technical fields) Solid experience with time-series analysis techniques such as FFT, peak detection, filtering, optimal: applied to IMU data from wearables or smartphones Knowledge of applying statistical
, statistics, computer science, engineering or related technical fieldsSolid experience and in depth knowledge of applying statistical methods such as linear mixed effect models, mixed models for repeated
qualification, CSV, calibration, maintenance and reliability engineeringReview and approve GMP records that cover technical change management, deviation management and CAPAs, risk assessments and SOPsCoordinate
technical source documents in accordance with project timelines for global submissionsReview high-quality CMC documentation for HA submissionConduct instrument qualification/decomisioning as System Owner and
qualification, CSV, calibration, maintenance and reliability engineering Review and approve GMP records that cover technical change management, deviation management and CAPAs, risk assessments and SOPs Coordinate
technical fields) Solid experience with time-series analysis techniques such as FFT, peak detection, filtering, optimal: applied to IMU data from wearables or smartphones Knowledge of applying statistical
, statistics, computer science, engineering or related technical fields Solid experience and in depth knowledge of applying statistical methods such as linear mixed effect models, mixed models for repeated
, packaging design, technical and timeline feasibility, efficiency and risk management Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical
, packaging design, technical and timeline feasibility, efficiency and risk management Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical
sufficiently address GMP and logistic related questions with line unit expertsScientific, technical and regulatory knowledge in a specific areaBasic knowledge of drug developmentDetailed knowledge of cGMP
external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessaryProactively identify scientific, technological and GMP challenges, propose
/or review of technical source documents in accordance with project timelines for global submissions Review high-quality CMC documentation for HA submission Conduct instrument qualification
external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary Proactively identify scientific, technological and GMP challenges, propose
sufficiently address GMP and logistic related questions with line unit experts Scientific, technical and regulatory knowledge in a specific area Basic knowledge of drug development Detailed knowledge of cGMP