- Takeda Pharmaceuticals (Cambridge, MA)
- …committees and with external experts/committees. The role is accountable for overseeing data generation activities, including phase 4 clinical studies, providing ... and in alignment with the commercial brand strategy and global product teams + Collaborate with Value and Evidence...industry at large. + Commitment to upholding the highest standards of data privacy, ethics, and regulatory… more
- Otsuka America Pharmaceutical Inc. (Phoenix, AZ)
- …& Analytics, Vendor & Contracts Management, Governance & Procedures, and Global Medical Evidence Operations ensuring alignment with enterprise goals and medical ... support decision-making across the organization. Serving as a key liaison across the Global , US, and Commercial ecosystem, the Executive Director will play a pivotal… more
- Takeda Pharmaceuticals (Boston, MA)
- …the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including ... in interactions with regulatory agencies + Advanced knowledge of clinical study designs, analysis methodology and data ...Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical… more
- AbbVie (North Chicago, IL)
- …labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical ... AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related… more
- Fortive Corporation (Minneapolis, MN)
- …cloud platforms (Azure preferred; AWS or GCP a plus). + Familiarity with healthcare data standards and clinical informatics. + Experience with regulatory ... collaborates with cross-functional groups to deliver AI-enhanced solutions aligned with clinical workflows and regulatory standards , leveraging the latest full… more
- Bristol Myers Squibb (Devens, MA)
- …apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of ... Manager collaborates cross-functionally with laboratory, manufacturing, quality, automation, and global IT teams to deliver solutions that enable scientific… more
- Vanderbilt University Medical Center (Nashville, TN)
- …University Medical Center** : Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of ... medical research. Our applications are continually evolving to incorporate more data sources and provide greater utility, requiring flexible software architecture… more
- ICON Clinical Research (Blue Bell, PA)
- …or office based ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving ... us on our mission to shape the future of clinical development. **Title:** Site Selection Lead **Role Summary:** The...appropriate follow through with sites on any inconsistencies in data provided for analysis and to chase outstanding … more
- Sumitomo Pharma (Providence, RI)
- …colleagues across the SMPA organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...inspection readiness and operational improvement activities. + Collaborate with Clinical Development to interpret safety data from… more
- Cytel (Helena, MT)
- …and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings ... Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the...study protocols + Proficiency with CDISC SDTM and ADaM standards + Solid understanding of clinical trial… more