- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader ... Authority Engagement:** Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections... Integrity:** Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality… more
- Sumitomo Pharma (Baton Rouge, LA)
- …and/or cross-functional inspection readiness and operational improvement activities. + Collaborate with Clinical Development to interpret safety data from ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job… more
- Datavant (Baton Rouge, LA)
- …team of product managers and product designers and collaborate deeply with data science, clinical experts, engineering, and commercial teams to accelerate ... a crucial role in expanding a platform that empowers clinicians with data -driven disease predictions, improving clinical decision-making, patient outcomes, and… more
- Ochsner Health (Lafayette, LA)
- …and participating in clinical trials. Organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory ... consent documents. + Analytical skills and ability to interpret data . + Ability to be self-directed. + Ability to...care. + Conducts all activity regarding the well-being and safety of human subjects enrolled in clinical … more
- Ochsner Health (New Orleans, LA)
- …This job provides strategic leadership and oversight for quality, patient safety , infection prevention and control, regulatory readiness, and performance ... leadership, medical staff, and operational leaders to implement effective quality and safety practices that improve clinical outcomes, patient experience, and… more
- Cardinal Health (Baton Rouge, LA)
- … clinical education programs + Provide timely feedback/information on emerging clinical /scientific data and opportunities from literature and market insights ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Fresenius Medical Center (Farmerville, LA)
- …service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory , FMS and FMS policy requirements. Manages and oversees the daily ... cost-effective facility operations in accordance with all legal, compliance and regulatory requirements and programs. Collaborates with the Medical Director and the… more
- Merck (Baton Rouge, LA)
- … development in industry is preferred. + Knowledge of the use of imaging in clinical trials for evaluation of efficacy and safety . + Skill in authoring and ... reviewing imaging documents for clinical trials. + Regulatory experience supporting drug...Clinical Research Management, Clinical Trial Development, Clinical Trials, Clinical Trial Support, Data… more
- Sumitomo Pharma (Baton Rouge, LA)
- … regulatory expectations. + Collaborate closely with cross-functional teams-including clinical development, clinical operations, data management, ... to serve as trial statistician for one or more clinical studies. He or she works closely with the...statistical design of the studies, and the analysis and data presentations for the studies. **Job Duties and Responsibilities**… more
- Ochsner Health (New Orleans, LA)
- …in maintaining a section that complies with the standards of accrediting/ regulatory agencies, and maintains confidentiality of patient related information at all ... experience (one year of which is in the appropriate clinical lab section) in appropriate clinical lab...advanced analytical skills necessary in order to analyze complex data and trouble shoot equipment **Certifications** Required - Current… more