- Highmark Health (Frankfort, KY)
- …team of specialists. Identify, develop, coordinate, and implement legislative, regulatory , sub- regulatory , and licensing / accreditation requirements.Perform ... ongoing monitoring and analysis of external regulatory and industry intelligence, collaborating with impacted stakeholders, and providing regular, executive… more
- Otsuka America Pharmaceutical Inc. (Frankfort, KY)
- …the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Cardinal Health (Frankfort, KY)
- …procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements ... minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Principal Specialist… more
- Bausch + Lomb (Frankfort, KY)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device ... completion of clinical studies according to applicable regulations and guidance , ICH and GCP, and Bausch & Lomb SOPs...are being met and provide the operations director and/or senior management with timely updates on progress and changes… more
- Otsuka America Pharmaceutical Inc. (Frankfort, KY)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... complements that of the Global Quality function. The leader shall provide guidance , strategic direction, and leadership to the Global Quality function with… more
- Prime Therapeutics (Frankfort, KY)
- …Enterprise Architect - Cloud Transformation - Remote **Job Description** The Senior Principal Architect is responsible for initiating and leading strategic solutions ... and information), shared infrastructure services and shared application services. The Senior Principal Architect leads the analysis and design tasks to support… more
- Merck (Frankfort, KY)
- …(eg, salaries & travel). + Country level operational study budgets. + Regulatory Inspections and internal audits; responding to inquiries by health authorities, ... ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory , Pharmacovigilance (PV) and Medical Affairs. + Responsible and supports… more
- Evolent (Frankfort, KY)
- …decision-making. + Act as a key resource for Initial Clinical Reviewers, offering guidance and expertise to ensure the application of best practices. + Provides ... with requesting physicians or ordering providers, when available, within the regulatory timeframe of the request. + Utilizes medical/clinical review guidelines and… more