- Pfizer (South San Francisco, CA)
- …knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Extensive understanding of related disciplines, ... eg, Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance. + Experience working on large data sets. + Proficiency with Microsoft Office and relevant scientific software + Effective… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and the nature of associated clinical trials across phases. + Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical ... procedures. + Strong communication and organizational skills. + When needed, ability to travel. **People Leader Accountabilities** + Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the… more
- Sumitomo Pharma (Sacramento, CA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …+ Experience with Class III medical devices + Knowledge/experience working in an FDA regulated environment. + Ability to use design software, SolidWorks 3DCAD and ... Microsoft Project or equivalents. + Statistical Analysis Experience Preferred (JMP, Minitab) + Experience working in clean rooms; liquid filling processes preferred. Salary ranges have been implemented to reward associates fairly and competitively, as well as… more
- Medtronic (Irvine, CA)
- …software - Part 1: General requirements for product safety + United States FDA Device Software Functions related Guidance's + United States FDA Interoperability ... - Security Risk Management for Device Manufacturers + United States FDA Pre-Market and Post-Market Product Cybersecurity Guidance's + European Commission's Guidance… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …a **maker of possible** with us. **Position Summary** The Senior Manager of EMI (Electromechanical Instrumentation) Quality Sustaining Engineering reports to the ... EMI plant locations will report directly to the Senior Manager and are under their authority for performance reviews,...evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface with… more
- Grifols Shared Services North America, Inc (Bakersfield, CA)
- …of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary ... Responsibilities:** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma… more
- Boehringer Ingelheim (Fresno, CA)
- …specialist role responsible for pull-through of the account plan (developed by the Account Manager ) at the Health System's various sites of care and with the Health ... Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company...Previous account management experience. * Various regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company… more
- Cedars-Sinai (Los Angeles, CA)
- …week, depending on departmental needs. Scheduling will be determined by the hiring manager in alignment with operational priorities. At this time, we can only ... study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and… more
- Lilly (San Diego, CA)
- …with current local and international regulations, laws, guidance's (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... + Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation… more