- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates. + Interpret and communicate ... of Phase I-IV investigations in preparation for a new drug . + Be the signatory on NDA submissions and...≥ 5 years of involvement in clinical research or drug development in an academic or industry environment across… more
- Norstella (Columbia, SC)
- …and healthcare service providers, including the top 10 global pharma and CROs. From drug and device discovery and development to regulatory approval, and from ... leading providers of data and intelligence on clinical trials, drug treatments, medical devices and what's new in the...cut through the clutter and make sense of changing drug development, regulatory and competitive landscapes. Now, Citeline is… more
- University of Colorado (Aurora, CO)
- …laboratory setting in conjunction with multiple grants and contracts related to advanced drug and device development aimed at treating hemorrhagic shock and ... Field:** + Toxicology + Critical Care Medicine + Translational Research + Drug Development + Pre-clinical Research **Work Location:** Onsite **Why Join Us:** **T**… more
- AdventHealth (Orlando, FL)
- …AdventHealth Research Institute (AHRI) research investigators with investigational new drug (IND), investigational device exemption (IDE), and/or biologics ... required documents/components to the FDA for AdventHealth held investigational new drug (IND)/investigational device exemption (IDE) or biologics applications. +… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be effective in managing work ... and context required of promotional labeling materials for prescription drug and medical device products. Must be effective in managing work and resolving… more
- Amgen (Washington, DC)
- …regulations + Drive the development of and end-end process/playbook to conduct combined drug and device trials + Conduct gap assessments of current ... frameworks + Deep understanding of the R&D (preferred clinical operations), drug development and commercialization process + Proven leadership experience in building… more
- HCA Healthcare (Overland Park, KS)
- …specific case report forms or electronic data capture systems + Generates and tracks drug shipments, device shipments, and supplies as needed . Ensures timely ... common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed… more
- United Therapeutics (Research Triangle Park, NC)
- …and their operational implications for a wide range of product types ( drug , combination, device reporting obligations) and relationships (partner, vendor, ... to business challenges and fosters innovation + Working knowledge of drug development processes and activities + Basic analytical thinking; diagnoses complex… more
- Northwell Health (Lake Success, NY)
- …on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application ... (NDA) or other research under the purview of the FDA. 10.Prepares and forwarding monitoring reports to program manager. Working with study staff to address any concerns. 11.Promotes overall compliance and quality with research conduct through participation in… more
- Massachusetts Institute of Technology (Cambridge, MA)
- …communications, software, transportation, and/or energy technologies, therapeutic, diagnostic, drug delivery, genetic engineering, medical device , ... biomanufacturing, biomaterials and/or drug discovery technologies Salary range: $160,000-$190,000 Please include a deal sheet and cover letter with application. This is a hybrid position. Tuesday and Wednesday are the TLO in-office core days; additional… more