Senior Compliance Officer, Global R&D and Tech Ops

Brief Description:

Reporting to theChief Ethics and Compliance Officer, theSenior Compliance Officer,GlobalR&D and Tech Opsisseniormember of theEthics,Compliance, andPrivacydepartment whowill play a critical role in advancing the company's strategy and commitment to compliance and ethics byreliably andproactively identifying, mitigating, and managing compliance and privacy related risks within those departments. The Senior Compliance Officer, Global R&D and Tech Opswill haveextensive knowledge oflaws 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 trialprotocols. Credible, commercially astute and pragmatic, theSenior Compliance Officer, Global R&D and Tech Opsisa solution-oriented decision makerand 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.Thepersonin this roleworksautonomously,is confident and proactive in his/her approach and concise,clearand unambiguous in his/her communications.

Job Responsibilitiesand Requirements:

• Serves asstrategicbusiness partnerand risk advisortoR&D and Tech Ops departmentsacrossall ofthevariouscountries andtherapeutic areasin which those departmentsoperate, providing regularupdates on compliance risk areas, mitigation strategies, and dashboardsevidencingcompliance programeffectiveness;

• Providescomplianceadvice and supporttothe R&D and Tech Ops,including,identifying,mitigatingand managingfraud and abuse and kickback risks associated with clinical trial and other developmentactivities; ethicaldecision-making in clinical trial protocol, strategy, and design,and trade sanctions relatedrisks;

• Serves as the subject matter expertand coordinates and collaborates with the Senior Compliance Officer, Global Policies, Education, and Investigations to develop global compliance and ethics policiesand associated training and education materials to support the R&D and Tech Opsdepartments;

• Regularly conduct compliancetraining;

• 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 oncompliance oversight of CRO and otherpartners;

• Serves as a key member of theEthics,Compliance, and Privacylead team, coordinating with other lead team members to advance the department's goals andobjectivesand to drive consistency in the approach to compliance and ethics across thecompany;

• Stays informed on new laws, regulations, and industry trends affecting the company and ensures that those new developments are appropriately reflected inthe compliance controls for the R&D and Tech Opsdepartments;

• Coordinates and collaborates with members of the Legal departmentsupporting the R&D and Tech Opsdepartments;

• WillinglyassistsEthics,Compliance, and Privacydepartmentcolleagues with projects and activities in areas outside of his/her primary areas of responsibility as needed to achieve corporateobjectives, contribute to a collegialatmosphereand balance workloads.

Requirements of this position include:

• 8+years of relevantcomplianceexperience, supportingpharmaceutical or bio-tech companieswith at least 2 yearsof experiencesupportingthe R&Dorganization ofa global pharmaceuticalcompany;

• Solidjudgment and business acumen and understanding ofR&Dand Tech Ops strategies and the ability toassesscompliancerisksand mitigation strategies in thatcontext;

• Solid understandingof laws and regulations governing the pharmaceutical or healthcare industry,particularly in the R&D and Tech Ops area,with experience in supportingglobalpharmaceutical companyoperations;

• Experience working in a business environmentacross multiple functions and geographies,withhigh levelof responsiveness andwith a strong customer serviceorientation;

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

• Able to work accurately withan appropriate senseof urgency and functioneffectivelyand efficiently in a fast-paced and dynamicenvironment;

• Strong interpersonalskills, including diplomacy, flexibility and collaborationand the ability tointerface effectively throughoutall levels of the organization as well as with external parties, and adaptable to circumstances and variety ofcultures;

• Travelrequired.

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