- Takeda Pharmaceuticals (Boston, MA)
- …of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer ... statistical analysis plans, CRFs, study reports) and processes. + Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and… more
- Takeda Pharmaceuticals (Boston, MA)
- …indicators, and metrics to support greater efficiency, consistency, and validation of business processes and decision-making. + Provides recommendations on ... managing CROs (ie Smartsheets, and other MS software tools) + Solid understanding of FDA Good Laboratory Practices (GLP) for nonclinical studies as set forth in 21… more
- Takeda Pharmaceuticals (Boston, MA)
- …analysis plans, CRFs, study reports) and processes. + Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles. + ... + Knowledge of regulations and best practices related to computer system validation , electronic records and signatures and data privacy. + Experience with budget… more
- Philips (Cambridge, MA)
- …support the development/update of product requirements, design verification strategies, design validation strategies and update of design trace matrices/DHF files in ... as internal quality system requirements. + Represent Philips as appropriate in FDA , notified body, internal and external audits. Mentoring of junior staff including… more
- Curia (Hopkinton, MA)
- …to production, proper life-cycle of analytical methods (ie validation /qualification, transfer, review, approval, changes), OOS/OOT investigations, stability programs ... phase-appropriate clinical and commercial expectations + Demonstrated knowledge of FDA and EMA regulations, ICH analytical guidelines, method transfers,… more
- Sumitomo Pharma (Boston, MA)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations + Advanced proficiency in BASE SAS… more
- Cytel (Boston, MA)
- …of CRFs, edit check specifications, data transfer specifications, and data validation plans. + Performing statistical analyses and interpreting statistical results. ... and explain the methodology and consequences of decisions. + Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes… more
- Cardinal Health (Boston, MA)
- …meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and ... standards, principles, and techniques utilized within the Quality Assurance field + FDA regulated industry experience as well as applicable Quality System Standards… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and best practices for data transformation, data integrity, test design, validation , and documentation; Integrate commercial data (sales, claims, prescription, payer ... new product and implement a new REMS module in TrackWise, as required by FDA ; Implement the Reltio MDM process across multiple countries for a major US healthcare… more
- Edwards Lifesciences (Boston, MA)
- …of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborating with core stakeholders to provide ... + Extensive understanding and knowledge of regulatory guidelines (eg, GCP, ICH, FDA , ISO) relevant to in Pharmaceutical/Medical Device research setting + Excellent… more
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