- J&J Family of Companies (Santa Clara, CA)
- …acoustic testing programs to support R&D projects. + Interface with R&D, Regulatory , Quality, IT and other cross-functional stakeholders to ensure acoustic lab ... operations are compliant to company policies and regulatory standards. + File regulatory reports for...duties as assigned. **Requirements** + MS in Acoustic Engineering, PhD is a strong plus. + Minimum of 15… more
- J&J Family of Companies (Irvine, CA)
- …independently; creating reports intended for internal distribution and for regulatory submission; creating internal presentations and white papers; and interfacing ... 1 and 2 job descriptions. + Interact with Biostatistics, Data Management, Regulatory , and Clinical staff to define and clarify project requirements. + Design… more
- US Bank (San Francisco, CA)
- …Bank's Model Risk Management Policy and Standards, and in adherence to applicable Regulatory Guidance. The individual in this position works with Model Owners and ... five or more years of related experience OR - PhD in a quantitative field, and four or more...understanding of applicable compliance laws, regulations, financial services, and regulatory trends that affect assigned line of business. .… more
- Medtronic (Northridge, CA)
- …concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions. The Senior Product Engineer applies scientific rigor in ... biological evaluation report (BER). + Liaise with internal (manufacturing, regulatory , quality, product development, supplier quality, post market surveillance,… more
- Edwards Lifesciences (Irvine, CA)
- …overcome market access barriers, and drive impactful evidence for clinical, regulatory , and commercial success. This role also includes direct people leadership ... professional meetings. + Ensure all projects comply with ethical standards, regulatory requirements, and internal quality guidelines. **What you will need… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …**pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. You will conduct analysis, execution and reporting of ... + Author **pharmacometrics sections** of clinical pharmacology documents for regulatory filings including annual reports, investigator's brochure, IND/NDA applications… more
- Cardinal Health (Sacramento, CA)
- …hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, ... of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …continued success. Deep expertise in US immigration law, global mobility, and regulatory compliance within a dynamic, highly regulated environment is key. An ... recruitment, mobility, and retention of foreign national employees. + Monitor regulatory changes and assess their impact on workforce planning and compliance.… more
- AbbVie (Irvine, CA)
- …pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans + Apply current regulatory ... with patient management experience + Master Public Health or PhD is preferred in addition to MD / DO,...cross functional stakeholders - internal and across industry, and regulatory authorities + A clear understanding of PV and… more
- Cytel (Sacramento, CA)
- …model-informed drug development), to provide strategic advice to define optimal regulatory , clinical and/or market access pathways and promote faster patient access ... recognized thought leader and strategic advisor in the areas of optimal regulatory , clinical development and/or market access pathways and quantitative strategies to… more