- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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 (Sacramento, CA)
- …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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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
- Stanford University (Stanford, CA)
- …patients. Specific studies include evaluation of novel monitoring devices and both investigational drug and device studies focusing on novel treatments for acute ... compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional… more
- First Databank, Inc. (FDB) (South San Francisco, CA)
- …This One, You Write History. Join the healthcare information technology team that's turning drug and medical device data into knowledge used by thousands of ... Pharmacy degree About FDB: FDB is the leading provider of drug and medical device knowledge that helps healthcare professionals make precise decisions. With… more
- First Databank, Inc. (FDB) (South San Francisco, CA)
- …This One, You Write History. Join the healthcare information technology team that's turning drug and medical device data into knowledge used by thousands of ... and Slack About FDB: FDB is the leading provider of drug and medical device knowledge that helps healthcare professionals make precise decisions. With thousands… more
- Cedars-Sinai (Los Angeles, CA)
- …the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications **Qualifications** **Educational ... field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures,… more
- Fortive Corporation (Irvine, CA)
- …+ Knowledgeable of US Food and Drug Law and regulatory, drug safety and/or device vigilance and/or regulatory/clinical research requirements in major ... geographies. \#LI-RB **Fortive Corporation Overview** Fortive's essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance,… more
- Danaher Corporation (Brea, CA)
- …and federal environmental regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ... ISO13485, European Union Medical Device Directives (MDD), and In-Vitro Medical Device Regulation (IVDR) as well as all other applicable global regulatory… more
- Abbott (Alameda, CA)
- …a plus. + Experience with either 510(k) applications, PMA supplements, NDA, BLA, US device regulations, US biologics regulations, US drug regulations or with EU ... continuous glucose monitoring systems. Working knowledge of insulin and drug solutions for diabetes management or past experience in...and other international medical device regulations and submissions. + Familiar with relevant regulatory… more