- Bristol Myers Squibb (Cambridge, MA)
- …with deep expertise in assay and IVD development-including analytical validation, clinical development, manufacturing, and global regulatory submissions through ... apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … publication plan for Rare Disease assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals ... with the Rare Disease Medical BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …publication plan for Nephrology & Immunology assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed ... with the Nephrology & Immunology BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial)… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …approved core scientific narrative and lexicon, accurately reflects clinical trial data , and maintains consistency across global materials + Maintain content ... and production of scientific assets, ensuring they accurately reflect clinical data , adhere to the core scientific...repositories and ensure version control and accessibility for global teams + Utilize platforms like Veeva Vault, to… more
- Pfizer (Cambridge, MA)
- …and oversee data governance frameworks-including master data management, data lineage, and metadata standards -to support high-quality, compliant data ... **ROLE SUMMARY** The Sr. Director, AI & Data is responsible for directly overseeing and organizing...Enterprise guidance and roadmaps across multiple business lines and global organizations. + Influence and direct a cross- functional… more
- Sanofi Group (Cambridge, MA)
- …not limited to FDA, OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR). + Oversee conduct of all clinical studies in adherence to both Company standards , and government/industry ... to applicable SOP(s). + Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data , and in the communication of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Participates in strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives ... and clinical trial design (protocol and CRF development), execution ( data collection, analysis, and interpretation), and closeout (final reporting). + Develops,… more
- Oracle (Boston, MA)
- …HDI's software, AI systems, data flows, and infrastructure meet strict global standards for security, privacy, MDR compliance, and AI safety. ... MDR (Medical Device Regulation), AI regulatory requirements, and emerging global security standards , we are expanding our...clinical data systems. + Experience with data privacy standards (GDPR, HIPAA, CCPA). +… more
- Sanofi Group (Cambridge, MA)
- …**Core Competencies:** + The ideal candidate has deep experience and knowledge of global drug discovery and early clinical development activities, with an ... and cross-functional leadership skills in highly matrixed environments. High ethical standards , data -centric objective mindset, attention to detail, comfortable… more
- Merck (Boston, MA)
- …reports to the Regional RMSD Team Leader - within US Medical Affairs, Global Clinical Development, Research and Development (R&D). **Location details:** + This ... Communicate external stakeholder opinions, insights and feedback on new data , clinical trends and the evolving vaccine...+ Develop and execute territory plans in alignment with global Virology strategy + Support data generation… more