- Cedars-Sinai (Beverly Hills, CA)
- …best practice care delivery, collaborating with other healthcare team members. + ** Regulatory Compliance:** Utilize knowledge of regulating agencies ( FDA , USP, ... and analyzing financial reports to identify opportunities for improvement. + ** Quality Assurance and Improvement:** Perform routine analysis and quality … more
- Nestle (Arvin, CA)
- …Sponsorship._ Position Summary: Ensures incoming finished product compliance with Nestle Quality Systems and Standards and other regulatory governances. ... and directs the daily activities of the Inventory and Quality Control Technicians by scheduling and assigning workloads, and...or sorting operations. + Assist with external audits by FDA , USDA, etc. INVENTORY CONTROL + Monitor open return/refusal… 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
- Sumitomo Pharma (Sacramento, CA)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more
- Abbott (Alameda, CA)
- …people in more than 160 countries. **The Opportunity:** The CRA will ensure quality , accuracy, and integrity of clinical trial data throughout the full lifecycle of ... (GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements. + Participate in study start up activities. +… more
- Insight Global (San Diego, CA)
- …ServiceNow, NetSuite) o Familiarity of Veeva and it's support functions including: clinical, quality , safety& regulatory * Experience with ERP * Experience with ... management experience (working in a pharmaceutical company with exposure to FDA regulations preferred) * Experience managing technical implementation projects in… more
- Sumitomo Pharma (Sacramento, CA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Norstella (Sacramento, CA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Abbott (Alameda, CA)
- …with all levels of the organization. + Ensure all automation processes comply with FDA , ISO 13485, and other relevant regulatory standards. + Maintain detailed ... streamline product return workflows, and ensure compliance with global regulatory standards. By aligning business needs with technical capabilities, this… more
- Abbott (Sylmar, CA)
- …regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating ... to meet daily production schedules while enhancing productivity and product quality . **What You'll Work On** *Design and develop manufacturing processes, tooling,… more