- Highmark Health (Juneau, AK)
- …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. (Juneau, AK)
- …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
- Edwards Lifesciences (Juneau, AK)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... and be part of our inspiring journey. As the ** Senior Specialist, Commercial Clinical Imaging** , you will be...and other imaging modality acquisition and interpretation and provide guidance on case planning strategy execution. + Responsible for… more
- Cardinal Health (Juneau, AK)
- …on those requirements. + Uphold quality standards that adhere to company, regulatory , and HIPAA policies and procedures. + Collaborate across various functions, ... skills with a proven ability to develop and execute effective quality assurance programs. + Works independently within established procedures; may receive general … more
- Bausch + Lomb (Juneau, AK)
- …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. (Juneau, AK)
- …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
- Evolent (Juneau, AK)
- …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