- Ascendis Pharma (Palo Alto, CA)
- …our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially ... and Preventative action (CAPA) as applicable. + Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- North Wind Group (Livermore, CA)
- …and able to meet pre-employment requirements including any required physicals, drug screen, and/or background investigation to satisfy clearance requirements from ... Intelligence (AI) to streamline and consolidate institutional documents and support regulatory compliance. As part of the Institutional Policy Office, the successful… more
- Fujifilm (Sacramento, CA)
- …leads and new relationships. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... standard requirements and all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications**… more
- Fujifilm (Sacramento, CA)
- …enforce all safety policies. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... standard requirements, and all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications**… more
- Parexel (Sacramento, CA)
- …countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, ... process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of...+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study… more
- AbbVie (Irvine, CA)
- …and reporting of non-clinical data and communications/agreements with global regulatory agencies in the areas of Translational Pharmacology, Non-clinical ... therapeutic areas. The organization is responsible for defining the relationship between drug exposure (eg, concentrations in blood/ local tissue) and efficacy and… more
- Genentech (South San Francisco, CA)
- …innovative and effective drugs using cutting edge technologies for manufacturing process ( Drug Substance and Drug Product), clinical supply, formulation, device, ... contribute to the development and scale-up of conjugation processes for Antibody Drug Conjugates (ADCs) and other innovative bioconjugates platforms. As a subject… more
- Parexel (Sacramento, CA)
- …countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, ... process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of...+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study… more
- Stanford University (Stanford, CA)
- …coordinate the oversight and implementation of research protocols assuring efficiency and regulatory compliance. The CRCA will be responsible for running a subset of ... the neuromuscular division's industry-sponsored drug trials. These may include...Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. +… more
- SpaceX (Hawthorne, CA)
- …cyber assurance program against industry standards, requirements (contractual and regulatory ), and organizational needs. + Governance: Managing and spearheading ... interpret and drive implementation of industry standards, requirements (contractual and regulatory ), and organizational needs. + Communications: Be "the face" of… more