- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient,… more
- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient,… more
- Cayuse Holdings (Raleigh, NC)
- …+ Translation Certifications. + Experience with State Department experience/ refugees, FDA , Health & Human services, Medical, Legal, Housing Authority etc. + ... Must be fluent inChuj + Must be able to pass a background check. May requireadditionalbackground checks as required by projects and/or clients at any time during employment. + The ability tofacilitatetranslation with discretion and impartiality. +… more
- Sumitomo Pharma (Raleigh, NC)
- …warehouse environment. + Ensure that all SAP solutions adhere to **GXP, FDA , and other regulatory requirements** applicable to the pharmaceutical industry, including ... validation and documentation standards. **Team Management & Governance** + Lead, mentor, and manage a team of internal SAP functional consultants, solution architects, and external system integrators. + Establish and enforce robust **SAP governance processes**… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …+ Coordinates and organizes final responses to regulatory inspections / audits ( FDA , EMA, CLIA/COLA, PPTA, State, Health Canada, internal compliance audits). + ... Supports donor centers with customer audits, completes requested customer-driven documents, and assists with development of audit responses. + Ensures donor center and corporate operations are compliant with Domestic / European regulations through routine… more
- BrightSpring Health Services (Washington, NC)
- …therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA ). + Proficiency in electronic medical records and pharmacy information ... systems + Strong clinical judgement, and effective written and verbal communication + *Position will be posted for a minimum of 7 business day About our Line of Business PharMerica, an affiliate of BrightSpring Health Services, delivers personalized pharmacy… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …programming infrastructure is robust, scalable, and compliant with regulatory standards (eg, FDA 21 CFR Part 11, GxP), and supports reproducibility and audit ... readiness. + Promote automation and standardization of programming workflows to improve efficiency and consistency across studies. **Project Delivery & Resource Management** + Accountable for the timely and quality completion of all programming deliverables… more
- Parexel (Raleigh, NC)
- …specimen requests, and verify part numbers for correct submissions. + Ensure FDA Section 508 accessibility compliance on US labels. **Global Implementation & Health ... Authority Engagement** + Support regional implementation of CDS updates and monitor compliance across markets. + Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations. + Prepare… more
- United Therapeutics (Research Triangle Park, NC)
- …their 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 others is an… more
- Fujifilm (Holly Springs, NC)
- …with all applicable regulatory requirements, including Food & Drug Administration ( FDA ), current Good Manufacturing Practices (cGMP), and Occupational Safety and ... Health Administration (OSHA) regulations. **Job Description** **What You'll Do** * Leads a team of I&C technicians through troubleshooting and repairing equipment failures, conducting preventative maintenance, and performing equipment modifications and… more