Palo Alto, CA30+ days ago
Serves as a strategic business partner and risk advisor to R&D and Tech Ops departments across all of the various countries and therapeutic areas in which those departments operate, providing regular updates on compliance risk areas, mitigation strategies, and dashboards evidencing compliance program effectiveness; Provides compliance advice and support to the R&D and Tech Ops, including identifying, mitigating, and managing fraud and abuse and kickback risks associated with clinical trial and other development activities; Ethical decision-making in clinical trial protocol, strategy, and design, and trade sanctions related risks; Serves as the subject matter expert and coordinates and collaborates with the Senior Compliance Officer, Global Policies, Education, and Investigations to develop global compliance and ethics policies and associated training and education materials to support the R&D and Tech Ops departments; Regularly conduct compliance training; Serves as the subject matter expert and coordinates and collaborates with the Senior Compliance Officer, Monitoring, Auditing, and Third-Party Risk Management to inform the design and implementation of an effective monitoring and audit program in support of the R&D and Tech Ops departments, with a particular focus on compliance oversight of CRO and other partners; Serves as a key member of the Ethics, Compliance, and Privacy lead team, coordinating with other lead team members to advance the department's goals and objectives and to drive consistency in the approach to compliance and ethics across the company; Stays informed on new laws, regulations, and industry trends affecting the company and ensures that those new developments are appropriately reflected in the compliance controls for the R&D and Tech Ops departments; Coordinates and collaborates with members of the Legal department supporting the R&D and Tech Ops departments; Willingly assists Ethics, Compliance, and Privacy department colleagues with projects and activities in areas outside of his/her primary areas of responsibility as needed to achieve corporate objectives, contribute to a collegial atmosphere, and balance workloads. The Senior Compliance Officer, Global R&D and Tech Ops will have extensive knowledge of laws and regulations relevant to R&D activities, including the False Claims Act, Anti-kickback Statute, anti-bribery and anti-corruption laws, Foreign Corrupt Practices Act, HIPAA, GDPR, and ethical decision making within clinical trial protocols.