Senior Compliance Officer, Global R&D and Tech Ops

Brief Description:  

Reporting to the Chief Ethics and Compliance Officer, the Senior Compliance Officer, Global R&D and Tech Ops is senior member of the Ethics, Compliance, and Privacy department who will play a critical role in advancing the company’s strategy and commitment to compliance and ethics by reliably and proactively identifying, mitigating, and managing compliance and privacy related risks within those departments.  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. Credible, commercially astute and pragmatic, the Senior Compliance Officer, Global R&D and Tech Ops is a solution-oriented decision maker and advisor, capable of collaborating across the Compliance and Ethics team, as well as with other key stakeholders, including members of the Legal, Regulatory, and Clinical Operations departments.  The person in this role works autonomously, is confident and proactive in his/her approach and concise, clear and unambiguous in his/her communications.  

Job Responsibilities and Requirements: 

• Serves as 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. 

Requirements of this position include:  

• 8+years of relevant compliance experience, supporting pharmaceutical or bio-tech companies with at least 2 years of experience supporting the R&D organization of a global pharmaceutical company; 

• Solid judgment and business acumen and understanding of R&D and Tech Ops strategies and the ability to assess compliance risks and mitigation strategies in that context; 

• Solid understanding of laws and regulations governing the pharmaceutical or healthcare industry, particularly in the R&D and Tech Ops area, with experience in supporting global pharmaceutical company operations;  

• Experience working in a business environment across multiple functions and geographies, with high level of responsiveness and with a strong customer service orientation;  

• Excellent communication skills, both oral and written, enthusiastic, self-motivated, efficient, able to handle heavy workload, able to proactively identify short and mid-term business needs to develop strategies and to manage responsibilities independently as well as facilitate teamwork; 

• Able to work accurately with an appropriate sense of urgency and function effectively and efficiently in a fast-paced and dynamic environment; 

• Strong interpersonal skills, including diplomacy, flexibility and collaboration and the ability to interface effectively throughout all levels of the organization as well as with external parties, and adaptable to circumstances and variety of cultures;  

• Travel . 

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