- Oracle (Baton Rouge, LA)
- …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. (Baton Rouge, LA)
- … 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
- Sumitomo Pharma (Baton Rouge, LA)
- …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 (Baton Rouge, LA)
- …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
- Ochsner Health (New Orleans, LA)
- …evaluates, initiates, and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility in coordination and collaboration ... to ensure understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements. Provides patient… more
- Ochsner Health (New Orleans, LA)
- …initiates, and maintains all activities related to the conduct of clinical trials. Communicates with external funding agencies, sponsors, departmental staff, and ... ensure the understanding of the requirements of conducting and participating in clinical trials. Independently organizes and manages all patient care requirements of… more
- Parexel (Baton Rouge, LA)
- …+ 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
- Parexel (Baton Rouge, LA)
- …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 (Baton Rouge, LA)
- …+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance ... as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. +...and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical… more
- Cytel (Baton Rouge, LA)
- …on your skill set, the role may also include strategic consulting on clinical , safety /pharmacovigilance, regulatory , and market access pathways to accelerate ... or technical domains relevant to product development. + Thorough understanding of clinical regulatory requirements, ICH/GCP guidelines, and ethical standards. +… more