- AbbVie (Irvine, CA)
- …of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents. *May ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- Abbott (Sylmar, CA)
- …investigational meetings and regulatory agency meetings. + Facilitates regulatory submissions and communications by communicating with Regulatory ... and cross-functional teams in order to develop clinical strategy. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge… more
- Stanford University (Stanford, CA)
- …case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. ... of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. These studies will be conducted at the Stanford Hospital and… more
- SMBC (Sacramento, CA)
- …with finance and compliance teams on CCAR documentation, data governance, and regulatory submissions **POSITION SPECIFICATIONS:** + Education & Experience + ... and data validation processes + Prepare monthly and quarterly regulatory reports including FR Y-14M and FR Y-14Q +...Generate regular and ad-hock risk reports for management and regulatory requirements + Perform deep-dive analysis on risk trends… more
- Sumitomo Pharma (Sacramento, CA)
- …and software + Ability to evaluate and write case reports and prepare regulatory submissions + Analytical thinking and attention to detail + Communication ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- Abbott (Alameda, CA)
- …design, statistical methodology, interpretation of results and inference) provided for regulatory submissions , discovery and development decisions **What You'll ... principles - Effectively presents statistical concepts and arguments to management, regulatory agencies and scientists - Provides meaningful and timely input in… more
- Abbott (Alameda, CA)
- …topics. + Participate in quality system improvement initiatives and support regulatory submissions as needed. **Required Qualifications** + Bachelor's degree ... state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and MDSAP. The Compliance Specialist… more
- Treasury Wine Estates (St. Helena, CA)
- …and laboratory practices. + Prepare and review documentation required for regulatory submissions and audits. Continuous Improvement: + Identify opportunities ... and instrumentation to analyze samples, interpret data, and ensure compliance with regulatory standards. The Analytical Chemist will work closely with the Senior… more
- Danaher Corporation (Los Angeles, CA)
- …APAC customs compliance strategy, including broker governance, valuation protocols, and regulatory submissions across diverse jurisdictions + Partner with ... is for someone who finds creative solutions to complex regulatory challenges and takes pride in developing innovative approaches...trade compliance, with focus on export controls and APAC regulatory regimes + Strong working knowledge of EAR, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inputs/outputs, verification, validation, and risk management deliverables. + **Contribute to regulatory submissions ** , including INDs, NDAs, and other global ... product development programs, ensuring alignment with design control and regulatory requirements. + **Ensure high-quality documentation** , including design… more