- Pfizer (Cambridge, MA)
- …researcher with a strong background in data handling, integration and analysis , exceptional full-stack software engineering skills, and a sound understanding of ... an omics data platform to enable efficient and scalable analysis of omics data + Development of innovative machine...Biology, Physics, Statistics, or a related technical discipline + PhD >1 year of relevant research experience in developing… more
- Teledyne (Billerica, MA)
- …Acceptance Testing (AT) of imaging sensors. The job will also conduct analysis , investigations and testing of considerable complexity for product development and ... of concept definition, requirements development, radiometric systems design and analysis , performance modeling and analysis , prototype testing, troubleshooting… more
- Merck (Cambridge, MA)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and… more
- Takeda Pharmaceuticals (Boston, MA)
- …aspects of signal detection/safety review activities. + Draft responses to regulatory /ethics safety questions. + Close working relationship with physicians, both ... technically and managerially. + Perform ad hoc analyses eg in response to regulatory queries. + Integral to Global Safety Teams and associated support. + Other… more
- Charles River Laboratories (Shrewsbury, MA)
- …study management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Serve as a Project Scientist ... responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company standard operating procedures and industry… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …downstream process technology transfers to CDMOs, including documentation review, gap analysis , and risk assessment. + Provide expert technical oversight of ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering ... continues to develop expertise in other key technical skills. + Conducts analysis of technical and conceptual risk through robust process characterization, failure… more
- Bristol Myers Squibb (Cambridge, MA)
- …Diseases. + Manage relationships with key internal stakeholders including regulatory , clinical and commercial and scientific communications and external ... collaborators to develop translational analysis plans and timelines, communicate analysis results....scientific, technical or medical journals. + **Qualifications** : + PhD degree in a neuroscience-related field + Minimum of… more
- Pfizer (Cambridge, MA)
- …clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents. + Provide leadership to ... with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with the Pfizer Oncology group… more
- ICON Clinical Research (Boston, MA)
- …statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager. + Development of medical ... content for regulatory document, and responses (including but not limited to...**You Are:** + Physician with MD or foreign equivalent; PhD nice to have + 5-10 years of clinical… more