- Merck (Rahway, NJ)
- …CDISC SDTM and ADaM standards + Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH + Designs ... drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical...Specific Required Skills and Experience:** + Programming expertise with clinical endpoint data (efficacy and safety) and… more
- Bristol Myers Squibb (Princeton, NJ)
- …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. (Trenton, NJ)
- …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
- Merck (Trenton, NJ)
- …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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …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
- Cytel (Trenton, NJ)
- …management, safety/pharmacovigilance, biostatistics, and medical writing teams to maintain high-quality data that meet global regulatory standards . **Medical ... relevant changes to project teams. **Cross-Functional Collaboration** + Work closely with clinical data management to ensure proper term collection and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …support program decisions. + Integrate published evidence with internal preclinical and clinical data to support mechanism of action and differentiation. **Study ... translatable clinical endpoints. + Collaborate in a matrix environment with global Otsuka Discovery Affiliates and external clinical researchers to align… more
- Oracle (Trenton, NJ)
- …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
- Oracle (Trenton, NJ)
- **Job Description** **About the Role:** At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented ... rate, the success of large, complex global health companies requires regulatory leaders who are deeply...product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and … more
- RELX INC (Trenton, NJ)
- …will translate strategy into action by operationalizing evaluation plans, ensuring data integrity, and maintaining rigorous standards for accuracy, completeness, ... Clinical AI Evaluation Specialist (Nursing) Do you love...in the health space? Do you like working with data and analytics to evaluate Generative AI models and… more