- Cook Medical (Bloomington, IN)
- … regulatory agencies related to material information* Track material compliance requirements with appropriate medical device standards and regulations* Serve as ... Technology is responsible for working collaboratively with biocompatibility specialists, regulatory scientists, toxicologists, engineers, project management, and internal and… more
- Lilly (Philadelphia, PA)
- …Develop, implement, and improve radiation safety procedures and processes to ensure compliance with regulatory and Company requirements - with accompanying ... in discovering and developing imaging agents that guide and transform precision pharmaceutical development in neuroscience and oncology for a company with an… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of clinical trial protocols for inflammation programs, ensuring scientific rigor and regulatory compliance . + Serve as the clinical lead on cross-functional ... key role in shaping clinical strategy, collaborating cross-functionally with research, regulatory , safety, and commercial teams to advance innovative therapies that… more
- AbbVie (North Chicago, IL)
- … regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements. + (SSG) Lead statistical ... advance medicines to our patients. Responsibilities + Provide expertise/lead regulatory submission and product life-cycle management strategy planning and… more
- Lilly (Indianapolis, IN)
- …Lead immunogenicity and biomarker activities and other clinical diagnostics in compliance with Lilly policies, local and international regulations, laws, guidance ... these strategies. + Develop, define, and deliver immunogenicity and biomarker related regulatory submission strategies and documents for Lilly assets. + Develop and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …and transition to production are delivered on schedule, within scope, and in compliance with regulatory and quality standards. This position reports directly to ... candidate will possess in-depth knowledge of clean room design, operation, and regulatory requirements, as well as hands-on experience with the installation and… more
- NANA Regional Corporation (Bethesda, MD)
- …pleasing, and infection-free environment that supports patient healing, research integrity, regulatory compliance , and an exceptional experience for all. ... evaluations, address performance issues, and recognize excellence. + Quality Assurance, Compliance & Regulatory Readiness:** + Design, implement, and oversee… more
- Teleflex (PA)
- …contracts based on substantial knowledge of financial/fair market value, regulatory and clinical requirements while demonstrating clinical knowledge. Recommend ... primary internal and external contact for contracts and payments. * Assure compliance with existing agreements and analyze need for contract amendments or renewals… more
- Prime Matter Labs (Miami Gardens, FL)
- …Develop, Review, Write, and Implement SOP's for quality functions and ensure compliance with all regulatory and GMP requirements. Demonstrated leadership and ... regulations. Conduct supplier audits, assessments, and risk evaluations to ensure compliance with quality standards. Collaborate with Supply Chain, R&D, Quality and… more
- WuXi AppTec (Middletown, DE)
- …methods and best practices. * Other QC tasks assigned by microbiology lead. Regulatory Compliance and Documentation * Ensure all activities are conducted in ... documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Microbiology Scientist will support both...strict compliance with cGMP, safety, and quality standards. * Maintain… more