- 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 ... programs. + Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety policies, procedures and… more
- Parexel (Newton, MA)
- …strategy to configure, distribute, and collect, review, and approve high- quality country-specific and site-specific documents, essential regulatory documents, ... Newton, MA to monitor and oversee clinical trials at client sites. Evaluate quality and integrity of reported data. Represent the company at assigned clinical trial… more
- Cytel (Cambridge, MA)
- …methods preferred. + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want our ... a critical role in analyzing complex manufacturing data to ensure product quality , consistency, and regulatory compliance. **As a Principal Biostatistician, your… more
- Sanofi Group (Cambridge, MA)
- …patient safety/pharmocovigilance, patient focused drug development, portfolio management, global regulatory and digital partners to foster innovation and ensure best ... goals and functional expertise across other EGDS functions and EGDS TAs. ** Quality Assurance of Statistical Approaches:** + As a group head of biostatistics… more
- Fujifilm (Boston, MA)
- …satisfaction and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job ... Provides on-going support to resolve application related and image quality concerns on both a product and system level....with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Fujifilm (Boston, MA)
- …satisfaction and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job ... Provides on-going support to resolve application related and image quality concerns on both a product and system level....with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Sanofi Group (Cambridge, MA)
- …candidate will work collaboratively in matrixed, cross-functional teams to generate high- quality and comprehensive data packages to nominate and advance therapeutic ... across internal groups and with external partners. + Prepare high- quality analyses, interpretation, documentation, and presentations to support project milestones,… more
- Amgen (Cambridge, MA)
- …method transfer and validation. + Experience in authoring and review of regulatory submission product quality sections and supporting documentation. Experience ... support to functions including but not limited to Drug Substance Technologies, Quality , and Manufacturing + Leverage latest advances in protein analytics to develop,… more
- Charles River Laboratories (Shrewsbury, MA)
- …of data. o Support key business financial, operational, client service, employee, quality goals and achieve targets. o Encourage and support global collaboration ... with study directors and their supervisors to ensure reports are of high quality . * Functional area(s) of expertise: Provide scientific oversight through both direct… more
- Sumitomo Pharma (Boston, MA)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more