- Stanford University (Stanford, CA)
- …of patient and research data in appropriate files per institutional and regulatory requirements. + Participate in monitor visits and regulatory audits. ... of Medicine is seeking a 6 month Fixed Term Clinical Research Coordinator Associate to perform duties...application. Duties include: + Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate… more
- Stanford University (Stanford, CA)
- …Nurse Manager to provide leadership and oversight of a significant number of clinical research projects, with an emphasis on supervising, evaluating, and ... training research staff. Responsible for managing clinical research operations, applying medical knowledge and...Develop and prepare operational and statistical reports for management, regulatory agencies, and research sponsors. * -… more
- Abbott (San Diego, CA)
- …international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory ... regulatory filing strategies based on proposed preclinical, clinical , and manufacturing changes. + Monitor the...in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research… more
- Bausch + Lomb (Sacramento, CA)
- …optimizing business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical , ... + Ensure operational excellence, compliance, and timely execution of deliverables. + Drive regulatory strategies for clinical , non- clinical , CMC and labeling… more
- Abbott (Santa Clara, CA)
- …regulatory review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical and manufacturing changes ... for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact...years of experience. + 2-3 years of experience in regulatory preferred but may consider quality assurance, research… more
- University of Southern California (Los Angeles, CA)
- …is seeking a Research Administratorto support our growing and dynamic research department. Reporting to the Senior Clinical Administrative Director II, and ... + Pre- and Post-Award Management: Oversee pre- and post-award processes for research projects, including contracts, grants, clinical trials, and philanthropic… more
- University of Southern California (San Diego, CA)
- …members Knowledge, Skills, and Abilities: + Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations + Knowledge of genetic ... including Down syndrome + Knowledge of ICH Guidelines regarding development phases, clinical research , and medical writing standard + Demonstrated ability to… more
- Abbott (Alameda, CA)
- … regulatory guidelines, policies and regulations + Ethical guidelines of the regulatory profession, clinical research and regulatory process ... processes, procedures + Provide regulatory input to product lifecycle planning + Monitor regulatory outcomes of initial product concepts and provide input to… more
- Sumitomo Pharma (Sacramento, CA)
- …functional groups + Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process ... diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research , and development to bring novel therapies to patients sooner. For more… more
- Cardinal Health (Sacramento, CA)
- …services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, ... actionable data governance policies and standard operating procedures (SOPs). + Monitor the evolving regulatory landscape and communicate potential impacts… more