- Highmark Health (Albany, NY)
- …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. (Albany, NY)
- …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
- Regeneron Pharmaceuticals (Troy, NY)
- …analytical skills and attention to detail. + Ability to translate complex regulatory requirements into clear guidance . + Strong stakeholder management and ... The Senior Data Governance Organizational Engagement Specialist cultivates a...practices across departments. + Stay abreast of industry trends, regulatory changes, and enforcement actions, assessing their impact on… more
- Lumen (Albany, NY)
- …manager to bolster and drive our compliance programs. Reporting to the Senior Director Security for GRC and Business Enablement, the information Security Governance ... our external and internal obligations. This role will be expected to provide guidance and make determinations relevant on controls that govern the steps, methods, or… more
- Edwards Lifesciences (Albany, NY)
- …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 (Albany, NY)
- …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 (Albany, NY)
- …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
- Regeneron Pharmaceuticals (Troy, NY)
- …a typical day might include the following: + Evaluate current and emerging regulatory guidance and industry intelligence concerning IOPS business practices. + ... Understanding of cGMP and GDP principles. + Capability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …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
- New York State Civil Service (Albany, NY)
- …and advancing applied research within the Division. The incumbents will: author guidance documents based on current state of water quality and resource management ... ensure DOW programs are managed according to best science and policy.4)Assist senior researchers and staff in carrying out the research process, including… more
- Evolent (Albany, NY)
- …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