- IQVIA (Carlsbad, CA)
- …- escalating quality issues as appropriate + Managing progress by tracking regulatory submissions , recruitment, case report form (CRF) completion, and data ... Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements. You should have: + A Bachelor's degree in a health care… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …for SOPs and production records. + Provide support to audits, change controls, and regulatory submissions , as needed. + May perform other duties as assigned. ... to potentially recommend process improvements that reflect understanding of regulatory requirements, business objectives, and cost implications. **Important Considerations:**… more
- J&J Family of Companies (Santa Clara, CA)
- …process, including research, planning, risk assessment, user interface requirements, and regulatory submissions . + Demonstrated ability to negotiate with ... techniques for evaluations. + Collaborate with R&D, Marketing, Medical Safety, Regulatory Affairs, Clinical Engineering, and Quality Engineering to design, evaluate,… more
- Stanford University (Stanford, CA)
- …audit study forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. ... project activities. + Serve as primary contact with research participants, funders, and regulatory agencies. _* -_ _The job duties listed are typical examples of… more
- IQVIA (Carlsbad, CA)
- …compliance, escalating quality issues as needed. Study Progress Management: Oversee regulatory submissions , recruitment, enrollment, CRF completion, and data ... query resolution. Support start-up phases as required. Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) per GCP/ICH and local regulations. Reporting: Generate visit reports, follow-up letters,… more
- HCA Healthcare (Campbell, CA)
- …and corporate documents in compliance with legal requirements. + Participate in annual regulatory submissions such as 1099 filing ensuring the accuracy of all ... internal audit schedules and preparing other required backup for annual and regulatory audits. + Prepare policy and procedure updates for responsible processes, in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …PK reports and regulatory documents (IND, IMPD, IB, BLA) for regulatory submissions . + Supervising of research scientists and associate scientists may ... be required. **Basic Qualifications:** Bachelor's Degree and 12 Years' Experience OR Masters' Degree and 10 Years' Experience OR PhD and 8 Years' Experience **Preferred Qualifications:** + Requires a highly motivated individual with a PhD and 10+ years of… more
- Abbott (Alameda, CA)
- …responsible for maintaining comprehensive research documentation for audits, inspections and regulatory submissions . Develop and/or conduct the continuous review ... Knowledge of data collection best practices for clinical trials familiarity with regulatory frameworks (eg, FDA, EMA, ICH-GCP). + Knowledge of global clinical… more
- Danaher Corporation (Sunnyvale, CA)
- …content of clinical study reports and review clinical and analytical sections for regulatory submissions to ensure data meets all necessary regulatory ... standards. + Review pertinent literature, prepare white papers/manuscripts, and provide education to Cepheid staff as needed. The essential requirements of the job include: + Bachelor's degree in Clinical Sciences, Health/Life Sciences, Molecular Biology,… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …and validation testing in accordance with FDA and ISO standards. Support regulatory submissions by documenting algorithm design, performance, and safety ... considerations. Guide and mentor engineers on new and emerging technologies and projects. **Qualifications:** A bachelor's degree in an Engineering or Scientific field with a minimum of 12 years of experience is required. Or a master's degree in an Engineering… more