- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** Lead technical professional experienced in designing, implementing, documenting, and executing complex technical projects. A person in this position is expected to possess an expert level… more
- Merck (Raleigh, NC)
- …management, communication, and networking skills + A thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant ... to the pharmaceutical industry and its customers + Ability to organize, prioritize, and work effectively in a constantly changing environment + Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote) + Familiarity with… more
- Kelly Services (Durham, NC)
- …and stand for up to a 12-hour shift. * Bio works preferably or FDA environmental experience (1-3 years required) Helping you discover what's next in your career ... is what we're all about, so let's get to work. Apply to be a Process Technician today! **\#GRACE** As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible… more
- Fujifilm (Durham, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** + BS or BE in Computer Science or a related field and/or equivalent work experience. + Thorough understanding of: + Microsoft Windows Server environments (Server 2012, Server 2016) + IIS… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Strong knowledge of compliance standards with the Food Drug Administration ( FDA ), international governing entities and Good Manufacturing Practices (GMPs) + ... Excellent oral and written communication skills + Excellent analytical and proofreading/editing skills + Strong MS Office and SAP skills + Ability to operate forklift truck and pallet jack + Depending on the area of assignment, directly related experience or a… more
- United Therapeutics (Research Triangle Park, NC)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many… more
- Teleflex (Morrisville, NC)
- …requirements. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, ... and all other international regulatory requirements with which Teleflex complies. TRAVEL REQUIRED: 50% (Domestic and International; overnight required) The pay range for this position at commencement of employment is expected to be between $118,000- $135,000… more
- BrightSpring Health Services (High Point, NC)
- …meetings and quality improvement activities + Adheres to all accreditation, OSHA, FDA , state, local and federal regulations, and USP 797 and USP 800 ... standards relevant to infusion pharmacy and home medical equipment + Documents all temperature logs, pressure and humidity monitors, records all sterility testing done in the clean room in compliance with company policies and procedures, and USP 797 and USP… more
- IQVIA (Durham, NC)
- …+ Expert knowledge of SDTM and ADaM data standards and FDA /PMDA/EMA submission requirements required + Therapeutic experience in Oncology, Virology, and/or ... Inflammation is preferred. . IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and… more