- Pfizer (Cambridge, MA)
- …studies involving primary data collection and secondary analyses of real-world data . + Author and review study protocols, reports, presentations (internally ... track record of delivering high quality results within timelines. + Able to review , evaluate, interpret, and present complex data ; understand the emerging safety… more
- Takeda Pharmaceuticals (Boston, MA)
- …authoring, review , and content verification for CTD Quality modules; Perform GMP testing data review and data integrity checks; Conduct data entry ... release and stability testing of multiple products currently under clinical development; Review , enter, and approve all GMP testing data for analytical… more
- Teledyne (Billerica, MA)
- …research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals who thrive on making an ... operational guidelines and protection. Ensures accuracy and completeness of data in master files and various support tools, such...Maintain Metrics and Inventory that pertain to SAP. + Review and act on conditions found in SAP Early… more
- Takeda Pharmaceuticals (Boston, MA)
- …in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP ... actions completed to address new and revised regulations. Oversees the review , completion and closure of routine and complex, impactful strategic clinical-related… more
- Takeda Pharmaceuticals (Boston, MA)
- …in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP ... Clinical Program Quality for complex clinical deviations and Serious Breaches. + Review the clinical deviations across studies managed by Clinical Program Quality… more
- Charles River Laboratories (Wilmington, MA)
- …requirements (ie FDA, USDA/APHIS, FWS, CDC, EPA) * Oversee the Post Entry review process for US and Canada importations and facilitate post summary adjustments * ... Conduct QBR's with Customs brokers to evaluate quality of services provided, review trends, and identify continuous improvement opportunities. * Train, motivate, and… more
- Burns & McDonnell (Newton, MA)
- **Description** The Senior Architect - Process will lead in the development of pharmaceutical and life science projects teams to create world-class designs for Life ... are set forth by clients and project colleagues. + Develop, modify, and review production drawings for Life Science facilities. + Participate in the development of… more
- Takeda Pharmaceuticals (Boston, MA)
- … required to support a high-quality database and planned analysis are collected; review Data Transfer specifications, Data Validation Plans, and various ... clinical trial methodologies to ensure the compliance with regulatory agencies and data reporting standards; create and review specifications for SDTM and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety ... for internal (eg, Takeda Safety Board) and external (eg, Independent Data Monitoring Committee) stakeholders. + Manages cross-functional assessment of benefit-risk… more
- Sanofi Group (Cambridge, MA)
- …Represents product supply in the global IBP process & committees (GDR, TA demand review , GSR, MBR) + Is accountable for correct validated & propagated net demand in ... E2E Supply Chain readiness for new product launches (master data , safety stock policy) aligned with IPL Team, Global...4+ years of experience of lifecycle management in the pharmaceutical industry, or equivalent. + Fluent in English. **Preferred… more