- IQVIA (Durham, NC)
- **Director, Data Sciences, Safety and Regulatory , FSP Sales** Director, Data Sciences, Safety and Regulatory , FSP Sales will contribute to a ... services for the Data Management, Biostatistics, Programming, Medical Writing, Lifecycle Safety , and Regulatory Affairs functions - and will be responsible… more
- Oracle (Raleigh, NC)
- …patient outcomes at global scale. HDI is uniquely positioned at the intersection of: + Clinical data + AI and advanced analytics + Cloud-scale infrastructure + ... **Job Description** Oracle Health Data Intelligence is hiring a Lead Regulatory...Every solution we deliver is designed with: + Patient safety first + Scientific rigor + Regulatory … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- … or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for ... clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety , regulatory personnel, and other functional ... adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. + Reconciles clinical supplies and drug accountability records… more
- Sumitomo Pharma (Raleigh, NC)
- …integrity, and review, interpretation, and communication of safety and efficacy data . + Present at scientific, medical, and regulatory meetings globally. + ... and patient advocacy groups. + Contribute to company's planned regulatory filings including authoring clinical sections for...NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety … more
- Sumitomo Pharma (Raleigh, NC)
- …and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output + Contributes to interpretation of clinical trial ... as required, and working with the safety group to ensure adequacy of safety monitoring and reporting + Provide clinical input for and participate in study… more
- Dentsply Sirona (Charlotte, NC)
- …+ Collaborate with R&D, Quality, Regulatory , and product marketing teams to ensure clinical relevance and safety of AI models and assist in methods to use ... study documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities. + Registration of clinical studies...follow up on time plan and budget. + Study data analysis, preparation of clinical study reports… more
- UNC Health Care (Raleigh, NC)
- …to care, and hospital throughput** . Bed Placement Nurses apply advanced clinical judgment, regulatory knowledge, and systems-level thinking to make high-stakes ... Nurse II - Bed Placement Nurse** plays a critical role in **patient safety , access to care, regulatory compliance, and hospital throughput** , supporting… more
- Parexel (Raleigh, NC)
- …new drug applications, Marketing authorization applications, Variations and Renewals) by reviewing safety data and preparing relevant sections of the filing ... where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and...safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician… more
- Parexel (Raleigh, NC)
- …+ When required Partners with other Study Team members (eg Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical ... is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study… more