- Bristol Myers Squibb (Seattle, WA)
- …laboratory information management systems (LIMS) or bioinformatics platforms. + Familiarity with regulatory standards for medical software (GMP, GxP, FDA, IEC ... + Ensure software quality through unit testing, code reviews, and adherence to regulatory standards (eg, GMP, GxP, FDA, IEC 62304) as applicable. + Troubleshoot,… more
- Humana (Austin, TX)
- **Become a part of our caring community and help us put health first** The Medical Director relies on fundamentals of CMS Medicare Guidance on following and ... health, SNF, DME, dual Medicare/Medicaid and Waiver requests. The Medical Director provides medical interpretation...performance standards. All work occurs with a context of regulatory compliance, and work is assisted by diverse resources… more
- Merck (North Wales, PA)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director ... to manage clinical development projects; and + Assist the Executive Director / Associate Vice President in ensuring that appropriate corporate personnel… more
- Nissha Medical Technologies (Buffalo, NY)
- …Introduction (NPI) **ID:** 2842 **Department:** Engineering **Location:** Buffalo, NY Description Nissha Medical Technologies is hiring for a ** Director of New ... Director of New Product Introduction (NPI) Summary **Title:**...will lead the successful onboarding and ramp-up of new medical device programs within a contract manufacturing environment. This… more
- Lilly (Indianapolis, IN)
- …and 7 years of clinical experience in a pharmaceutical, biotech, CRO, or Regulatory agency and established analytics background, preferably in Fabric/Power BI. + 3-5 ... years of clinical experience in a pharmaceutical, biotech, CRO, or Regulatory agency. + Broad-based knowledge of the pharmaceutical business, R&D processes, and… more
- Lilly (Indianapolis, IN)
- …and adoption of best practices. + Compliance: Ensure adherence to regulatory requirements, data privacy, and security standards. **What You Should Bring:** ... for innovation and continuous learning. + Compliance Awareness: Knowledge of regulatory , privacy, and security standards relevant to the pharmaceutical industry.… more
- Lilly (Indianapolis, IN)
- …quality, engineering, and continuous improvement. + **Interact** directly with regulatory agencies during site inspections. **Minimum Requirements:** + Bachelor's ... (Rockwell, BnR, etc.). **Additional Preferences:** + Solid Understanding of Basic Requirements of Regulatory Agencies Such as the FDA, EMEA, DEKRA, And Osha in a GMP… more
- Lilly (Indianapolis, IN)
- …and change management activities for Batascript, ensuring user needs and regulatory expectations are met. + Monitor system usage and performance metrics ... **3. Maintain 'Right-to-Operate'** + Ensure both systems meet all regulatory , quality, and corporate policy requirements, maintaining validated states and… more
- RTX Corporation (Boston, MA)
- …schedules, and compliance requirements. + 5+ years' of knowledge of Regulatory Requirements: Familiarity with regulatory requirements and standards related ... may be eligible for benefits, including but not limited to, medical , dental, vision, life insurance, short-term disability, long-term disability, 401(k) match,… more
- Humana (Baton Rouge, LA)
- …Information Typically reports to a Regional/ Associate Vice President, Lead, or Corporate Medical Director , depending on size of region or line of business. ... caring community and help us put health first** The Medical Director actively uses their medical...be authorized. All work occurs within a context of regulatory compliance, and work is assisted by diverse resources,… more