- J&J Family of Companies (West Chester, PA)
- …advanced biomaterials such as ceramic bone void fillers, bioabsorbable polymer implants, drug - device combination products, and cell-based therapies. We engage in ... early stage evaluation of new materials technologies, device design and development, manufacturing process development, and support of preclinical testing and… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug - device combination products. + Determine regulatory ... including biologic upstream and downstream processes, analytical methods, and drug / device combination products. + Comprehensive knowledge and experience… more
- Lilly (Indianapolis, IN)
- …person for review and release of Raw Materials, Drug Substance, Drug Product, and/or Drug - Device Combination Products. **Additional Skills/Preferences:** ... Records and electronic review and disposition processes across materials, drug substance, drug product, device assembly, and packaging. + Experience… more
- System One (Park Ridge, NJ)
- …for New and Existing Product Development (NPD/EPD) pipeline for products in the drug (OTC, DIN, NHP), medical device , cosmetic, disinfectant (EPA, DIN) and ... technical (CMC) writing to accelerate the development of small molecules, combination drug / device products, and other innovative materials for areas with high… more
- Vera Therapeutics (Brisbane, CA)
- …to commercialization. The ideal candidate will have a strong background in drug delivery systems, medical device and combination product regulations. Exceptional ... degree preferred * 8 years of experience in quality oversight of drug product device development, with a proven track record of successful product launches *… more
- New England Cancer Specialists (Topsham, ME)
- …Product preparation - + Prepares ambulatory chemotherapy infusions and calibrates the infusion device for drug administration per physician order. + Reviews all ... Policy and Procedures: Perform physician-controlled agent inventory and restocks the drug preparation area. Logs all chemotherapy waste and expired drugs according… more
- Guidehouse (New York, NY)
- …Consulting Health Care Practice. Our clients include - pharmaceutical, biotechnology, medical device , drug delivery and diagnostic. Examples of Guidehouse Life ... Sciences diverse consulting assignments include therapeutic area strategy development, product opportunity assessments, commercial strategy, business development search and evaluations, due diligence, market access strategy, new product launch planning and… more
- Mount Sinai Health System (New York, NY)
- …of work laboratory, other vendors, and CROs; consultant agreements; investigative device / drug labels; clinical study worksheets; etc.). + Monitors ... resources/reports to deliver milestones on time and budget. + Collect, reviews and files all clinical study documentation for assigned trial(s) and investigative sites and maintenance of clinical trial master file (CTMF): assures all documentation is… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Federal Markets including VA, Department of Defense and 340B Program preferred. + Device / Drug combination strongly preferred + Minimum 5 years of people ... management experience required + Track record of closing complex negotiations within the specialty pharmacy arena + Preferred experience includes: + All aspects of distribution + Launch and life cycle management for the distribution process + Experience in… more
- Cordis (Irvine, CA)
- …specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and ... with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.… more