- Houston Methodist (Houston, TX)
- …exceptional patient care and adheres to standards and guidelines established by regulatory agencies and Houston Methodist to ensure optimal patient safety and ... for patient satisfaction, through peer-to-peer accountability to service standards. ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + Follows the clinical research protocol… more
- Houston Methodist (Houston, TX)
- …of the department's major projects/grants. Assists in writing SOP's and other regulatory requirement documentation. + Maintains and provides in-services for the HM ... technology transfer, legal, grants and contracts, and business practices. ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + Maintains organized records of successful… more
- Houston Methodist (Houston, TX)
- …portals and Clinical Trial Management System following established procedures. ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + Maintains records for clinical study and ... regulatory documents. + Under the direction of Research Nurse/Clinical...research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387… more
- Sumitomo Pharma (Austin, TX)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Sumitomo Pharma (Austin, TX)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more
- Norstella (Austin, TX)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Wolters Kluwer (Coppell, TX)
- …well understood, technically feasible, and delivered on time and with quality . * Collaborate with go-to-market teams (Marketing, Sales, Pricing, Customer Experience) ... Demonstrated success managing product line projects, including risk mitigation, regulatory awareness, translating customer needs into business requirements, stakeholder… more
- Abbott (Irving, TX)
- …with regulatory standards and maintain the effectiveness of the quality system Additional Details + Travel: Approximately 10%, with potential increases during ... analysis, and hands-on service support to ensure product excellence and regulatory compliance. **Product & Process Development** + Independently lead and oversee… more
- Catholic Health Initiatives (Houston, TX)
- …Section in accordance with institutional, state and federal standards, ACR, and FDA . Assists in reviewing and revising department policies and procedures to ensure ... continuity in compliance with JCAHO, DNV, and other regulatory requirements. **Position Responsibilities:** + Performs all Functions of an MRI Technologist position.… more
- Houston Methodist (Houston, TX)
- …the daily work activities of the work unit/department staff, ensuring quality , productivity, functional excellence and efficiency while assisting management in ... secure compliance with ethical and legal business practices and accreditation/ regulatory / government regulations. **PEOPLE ESSENTIAL FUNCTIONS** + Performs management… more