- Veterans Affairs, Veterans Health Administration (Syracuse, NY)
- …to, The Joint Commission, National Fire Protection Association, Food and Drug Administration, Nuclear Regulatory Commission, Association for the Advancement ... management system. This documentation is completed in accordance with regulatory body requirements, the Office of Healthcare Technology Management Documentation… more
- Lilly (Indianapolis, IN)
- … drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and manufacturing ... people around the world. **Job Summary** The Director/Senior Director, CMC, Drug Product Development will lead formulation development activities across multiple… more
- The Boeing Company (Berkeley, MO)
- …and treatments (wound care, immunizations, phlebotomy, vision/hearing screens, drug testing, spirometry), regulatory -compliant documentation, and coordination ... (EKG, spirometry/PFT, phlebotomy, blood glucose, audiograms, vision screens, vitals) and drug free workplace specimen collection + Coordinate case management: return… more
- ThermoFisher Scientific (Greenville, NC)
- …Projects, ideally from concept to launch + Understanding of device and drug /device combination regulatory requirements + Understanding of device design and ... and line templates. This role involves ensuring compliance with regulatory standards, optimizing manufacturing processes, and collaborating with vendors. The… more
- City of New York (New York, NY)
- …and contribute to operational improvements across areas such as case management for drug -resistant TB, regulatory affairs, and the evaluation of newly arrived ... data from surveillance systems and electronic medical records. Assist the Regulatory Affairs Unit in drafting Commissioner's Orders for patients requiring legal… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4-panel drug screen * + Meet Regulatory Requirements for pre-employment screenings. + ... senior Clinical Laboratory Technologist. + The new Incumbent will assists in the regulatory mandated inventory control process by tracking the Core Lab reagent lot… more
- University of Southern California (Los Angeles, CA)
- …span the entire spectrum of pharmaceutical development and clinical care - from drug development to regulatory approaches that promote safety and innovation, to ... include: Doctor of Pharmacy (PHRD 641 - Focused Sports Physical Assessment and Drug Development) Doctor of Pharmacy (PHRD 642 - Sports and Dietary Supplements)… more
- Amgen (Washington, DC)
- …implementation, analysis and reporting + Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions + ... trial designs (including adaptive and/or Bayesian) in different phases of drug development + Expertise in advanced statistical analysis methods, modeling and… more
- ThermoFisher Scientific (Lawrenceville, NJ)
- …antibodies (ADA), and neutralizing antibodies (NAb) in biological samples to support drug development and regulatory filing. **Essential Functions:** * Develops, ... with some level of guidance * Ensure assay performance meets regulatory expectations for specificity, sensitivity, precision, accuracy, and robustness. *… more
- Bristol Myers Squibb (Cambridge, MA)
- …candidates with Biomarker Lead late stage clinical trials for Phases II/III preferred. Regulatory submissions drug approvals in solid tumor space also highly ... the development of immuno-oncology therapies and continues to diversify in drug development for the treatment of cancers. Our world-class Translational Development… more