• Senior Manager of Biostatistics

    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
    Sumitomo Pharma (04/24/25)
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  • Data Science Engineer

    Takeda Pharmaceuticals (Lexington, MA)
    …and best practices for data transformation, data integrity, test design, validation , and documentation; Integrate commercial data (sales, claims, prescription, payer ... to 50% remote work allowed. **REQUIREMENTS:** Bachelor's in a Computer Science, Information Systems, or data related field plus...a new REMS module in TrackWise, as required by FDA ; Implement the Reltio MDM process across multiple countries… more
    Takeda Pharmaceuticals (04/19/25)
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  • Principal Product Security Engineer

    Stryker (Boston, MA)
    …then applied at build and configuration, provide oversight through verification and validation . Once the product is on-market, this team also aids others with ... taskforce teams. **Knowledge and Capabilities:** + Understanding of the current revisions from FDA , NIST, ISO, IEC on the related security topics. + Expertise in… more
    Stryker (04/17/25)
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  • Equipment Maintenance Technician

    Catalent Pharma Solutions (Chelsea, MA)
    …required, preferably in cGMP biopharmaceutical; pharmaceutical, medical device, food, or other FDA regulated industry; + Basic to moderate computer skills - ... consumer, and Catalent employee.** **The Role** + Provide support for validation , calibration, and preventative maintenance of all GMP equipment and systems;… more
    Catalent Pharma Solutions (04/01/25)
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  • Senior Software Verification Engineer

    Globus Medical, Inc. (Methuen, MA)
    …with Git, Qt, Test Track Pro, and Jira + Experience with documentation and validation testing for FDA regulated industries, a plus + Working knowledge of ... to perform these essential functions._ **Qualifications** **:** + Bachelor's Degree in Computer Science, Engineering or related field + Proven experience as a… more
    Globus Medical, Inc. (03/27/25)
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  • Data Solutions Specialist (Dashboards, APIs,…

    Mentor Technical Group (Boston, MA)
    …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... interoperability. + Ensure data quality, accuracy, and integrity through robust validation and monitoring practices. + Manage data sources across categories such… more
    Mentor Technical Group (03/22/25)
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