- ZOLL Medical Corporation (Chelmsford, MA)
- …team members in scientific and clinical affairs, product development, regulatory , quality, and manufacturing. Essential Functions: * Contribute to, and ... electrical engineering, or related field with emphasis in biomedical signal processing; PhD degree preferred * 5+ years of experience in signal processing algorithm… more
- Takeda Pharmaceuticals (Boston, MA)
- …strategy deliverables including COA development plans, study protocols, statistical analysis plans, scientific reports, briefing packages, clinical study reports, ... and regulatory labelling interactions. + Provide technical expertise and guidance...Prepares and/or reviews clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports. + Familiarity with software… more
- Sanofi Group (Cambridge, MA)
- …team). + Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.). + Coordinate clinical ... manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from various disciplines;… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference ... (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with...AND SKILLS:** **Education & Experience** + Pharm D. or PhD with 8+ years of working experience in a… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or ... regional regulatory agencies and be responsible for clinical pharmacology summary...desired minimum years industry experience: + Pharm D. or PhD with 8+ years of working experience in a… more
- Bristol Myers Squibb (Cambridge, MA)
- …clinical development plans + This leader will supervise the development, monitoring, analysis and interpretation of clinical trials and will supervise and have ... accountability for the clinical components of regulatory filings + Will contribute to overall strategy for...documents delegated as needed **Qualifications & Experience** + MD ( PhD or other high level degree optional) **Experience Requirements:**… more
- Cytel (Cambridge, MA)
- …Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study ... Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies. + Writes the statistical sections… more
- Lilly (Boston, MA)
- …medicines for patients. **Position Overview:** We are seeking a highly skilled and motivated PhD level scientist to join our Diabetes team. This position will play a ... + Ensure all gene editing activities comply with relevant regulatory guidelines and standards. Maintain excellent scientific documentation, prepare reports,… more
- MAPFRE Insurance (Webster, MA)
- …forefront of transforming how we use data to make decisions. **What You'll Bring:** + PhD or Master's in a quantitative field + 8+ years in data science, Insurance ... monitoring, and retraining with a focus on fairness, explainability, and regulatory compliance. 7. **Expand AI Capabilities Through Partnerships** Collaborate with… more
- ConvaTec (Lexington, MA)
- …samples, executing experiments, troubleshooting, recording all data, and conducting data analysis . + Utilize expertise and available literature in biology, cell ... form of technical presentations & reports. + Collaborate with project management, regulatory , clinical, etc. teams to stay aligned on key goals, deliverables,… more