- 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
- 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
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …them into clinical development plans to support drug development and regulatory packages **.** + Lead ** clinical pharmacology** activities related to study ... performed and presented. Author PK reports that are integrated into clinical and regulatory documents. + Lead development of ** clinical pharmacology**… 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
- 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
- Actalent (Houston, TX)
- … regulatory requirements, and institutional policies, collaborating closely with clinical teams, sponsors, and regulatory bodies. Responsibilities + Extract ... Ensure compliance with federal, institutional, and sponsor regulations. + Collaborate with clinical , informatics, regulatory , and quality teams. + Participate in… more
- Elevance Health (Houston, TX)
- …benefits. + Lead end-to-end program development: including opportunity identification, clinical research and analytics, regulatory alignment, implementation, ... high-cost specialty drugs, including biosimilars. + Ability to translate complex clinical and regulatory concepts into business strategies. + Strong… 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
- 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
- Immigration and Customs Enforcement (Pearsall, 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