Senior Compliance Officer, Global R&D and Tech Ops

Jazz Pharmaceuticals; United States; Remote; USD 230,000 - 346,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a Senior Compliance Officer for Global R&D and Tech Ops to lead compliance strategies across multiple countries and therapeutic areas. You will provide risk-based guidance, develop policies, and drive training and monitoring programs within the Ethics, Compliance, and Privacy function.

You will stay current on evolving laws (FCA, HIPAA, GDPR, FCF) and work with Legal, Regulatory, and Clinical Operations to support compliant trial protocols and business operations.

Qualifications

• 8+ years of relevant compliance experience in pharmaceutical or biotech industries.
• Strong business acumen and understanding of R&D and Tech Ops strategies.
• Knowledge of laws governing pharma/healthcare, especially in R&D and Tech Ops, with global operations experience.
• Experience working across functions and geographies with strong responsiveness and customer service orientation.
• Excellent communication skills, both oral and written, proactive and able to manage workload independently and facilitate teamwork.
• Ability to work accurately with urgency in a fast-paced environment.
• Strong interpersonal skills, diplomacy, flexibility and cross-cultural collaboration.
• Travel required.

Responsibilities

• Serves as strategic business partner and risk advisor to R&D and Tech Ops across countries and therapeutic areas, providing updates on risk areas and mitigation strategies.
• Provides compliance advice to the R&D and Tech Ops teams, identifying and managing fraud, abuse, kickback risks, and ethical decision-making in trials.
• Coordinates with global policies, education, and investigations to develop compliance policies and training for R&D and Tech Ops.
• Regularly conducts compliance training.
• Supports the design and implementation of an effective monitoring and audit program for CROs and partners in R&D and Tech Ops.
• Works with the Ethics, Compliance, and Privacy lead team to drive consistency across the company.
• Keeps informed on new laws and industry trends and updates compliance controls accordingly.
• Collaborates with Legal for R&D and Tech Ops support.
• Assists colleagues with cross-functional projects to achieve corporate objectives and balance workloads.

Job description

Jazz Pharmaceuticalsis a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered inDublin, Irelandwith research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.comfor more information.

Job Description

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 on compliance 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 department supporting 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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Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.For this role, the full and complete base pay range is:

$230,400.00 - $345,600.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate’s expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company’s Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html