- BeOne Medicines (San Mateo, CA)
- …ethics committees + Lead the authoring and review of safety sections of regulatory submissions , eg, IND/CTA (General Investigational Plans, China Risk Control ... evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this… more
- Vera Therapeutics (Brisbane, CA)
- …clinical trial readiness, including compliant labeling, packaging, and documentation for regulatory submissions . * Maintain audit readiness and lead ... with a strong focus on vendor selection and performance management, regulatory compliance, risk mitigation, contract oversight & management and operational… more
- J&J Family of Companies (Irvine, CA)
- …statistical reports that may be incorporated into internal clinical reports or regulatory submissions . + Contribute to peer-reviewed articles independently, in ... independently; creating reports intended for internal distribution and for regulatory submission; creating internal presentations and white papers; and interfacing… more
- Medtronic (Northridge, CA)
- …concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions . The Senior Product Engineer applies scientific ... and projects + Author, execute, review, and approve protocols, reports, and/or regulatory submissions pertaining to biocompatibility and/or clinical evidences +… more
- Abbott (Alameda, CA)
- …Participate in the interim and final reviews of study data in preparation of regulatory submissions . + Involved in the preparation of all applicable documents ... (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements. + Responsible for assisting senior staff in planning… more
- AbbVie (Irvine, CA)
- …of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… 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 ... and work under close direction of the principal investigator and/or manager /supervisor. The CRCA will support federal and non-federal clinical research studies… more
- Abbott (Sylmar, CA)
- …investigational meetings and regulatory agency meetings. + Facilitates regulatory submissions and communications by communicating with Regulatory ... teams in order to develop clinical strategy. Interacts with regulatory agencies as needed, and will use their scientific...and legal interactions are expected as directed by the manager . + Responsible for compliance with applicable Corporate and… 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
- Bristol Myers Squibb (Brisbane, CA)
- …institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Provides guidance and ... areas and projects + Key contributor to Clinical Development Plans, submissions , and post-submission strategies/preparation/ defense as needed + Represents the… more