- MD Anderson Cancer Center (Houston, TX)
- …of this role is to direct, plan and coordinate protocol submissions and regulatory processes. In addition, the Clinical Research Regulatory Specialist ... - Master's Degree *Required Experience* - 7 years of experience in clinical research, regulatory compliance and quality assurance or 5 years of experience in … more
- MD Anderson Cancer Center (Houston, TX)
- *Coordinator, Clinical Research Regulatory - Leukemia* *MISSION STATEMENT* The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate ... the National Cancer Institute. *Job Summary* We are seeking a highly motivated Regulatory Compliance Specialist to support clinical trial operations. This role… more
- Merck (Austin, TX)
- …+ Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory due diligence activities ... chemistry, or related discipline with 10+ years of relevant drug development, clinical , or regulatory experience. + MD or Ph.D./Pharm D with 7+ years of… more
- Houston Methodist (Houston, TX)
- …Operating Procedures (SOPs), and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical ... and notifies IRB of study closures. + Maintains the required regulatory files for all clinical trials to ensure regulatory compliance. Meets with study… more
- Sumitomo Pharma (Austin, TX)
- …and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical ... data analysis. + Provide medical expertise to cross-functional teams, including regulatory , commercial, and clinical operations. + Provide day-to-day practical… more
- Abbott (Plano, TX)
- …and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, ... upon review of submissions. + Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- … clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is ... + Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in the field to… more
- Methodist Health System (Dallas, TX)
- …:** Your Job: The Regulatory Specialist will perform expertise in the regulatory component of all clinical research trials to include, but not limited ... IV clinical , investigator initiated trials (IITs), and retrospective analysis of clinical data. The Regulatory Specialist will support the mission, vision,… more
- IQVIA (Dallas, TX)
- …in lieu of degree. Req * Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. * ie, Good Clinical Practice (GCP) ... in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive,...* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report… more
- Immigration and Customs Enforcement (Houston, TX)
- …evaluating clinical case reviews for adequacy of care, compliance with clinical and regulatory guidelines, overpayment, and audit recovery; and developing ... (ERO), ICE Health Service Corps (IHSC), Office of Deputy Assistant Director of Clinical Services (DAD-CSU). This is a supervisory position. This position is only… more