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Helping clients to improve lives is what we do. Science is how we do it.
Innovative science is at the core of all we do as an organization. Across all phases of biopharmaceutical drug development, from strategy through execution, science permeates the mindset of every member of our highly experienced teams and every step of our unique approach. Efficient and effective clinical development that supports our clients in helping improve people's lives is what we do. Science is how we do it.
PRA Health Sciences in seeking an experienced, senior level Compliance and Ethics professional to join the Risk Management team. Reporting to the VP, Assistant General Counsel and Global Risk & Compliance Officer (“Risk & Compliance Officer”), this individual will be a strategic and collaborative leader responsible for providing legal advice and direction on a range of legal compliance matters throughout the organization. The individual will establish and implement an effective global compliance program to prevent illegal, unethical, or improper conduct and will manage the operations of the global Corporate Compliance and Ethics program. This role will function as the senior internal attorney for actions and initiatives involving compliance and ethics.
Design, implement and manage the global Ethics and Compliance program.
Work collaboratively with senior leadership in the development and improvement of the compliance and ethics program. Establish effective working relationships and build credibility within the Company, especially at senior management and operational leadership levels, influencing without direct authority to support a culture of ethics and compliance.
Advise senior management and operational leadership on issues concerning compliance and ethics matters including recommending controls designed to ensure compliance.
Support the Global Risk & Compliance Officer in the evaluation and management of the effectiveness of the ethics and compliance program.
Revise, develop and implement a Compliance and Ethics Charter, applicable compliance and ethics policies, procedures, and guidance.
Annually review and update, as appropriate, the Code of Conduct.
Implement policies and procedures that encourage employees, leadership, contractors, and clients to report compliance concerns without the fear of retaliation.
Manage the Ethics Hotline. Independently investigate or support supervision of the investigation of compliance and ethics concerns that are raised through Ethics Hotline, internal reporting, or other reporting mechanisms.
Develop an annual Compliance Work Plan outlining Compliance department work activities for the upcoming year.
Assist the Risk & Compliance Officer in long-range strategic planning for the Compliance Program in response to quality assurance and process improvement activities and industry-leading best practices for effective compliance and ethics programs. Remain abreast of industry best practices and changing standards.
Design and implement innovative approaches to support continuous auditing and monitoring of operations in support of the Compliance Program through data mining, analytics, and benchmarking.
Prepare compliance reports for submission to the Risk & Compliance Officer, Board of Directors, and Risk and Compliance Steering Committee, including but not limited to ethics and compliance matters, activities of the Compliance department, and the completion status of annual Compliance Work Plan.
Institute and maintain an effective compliance communication program for the organization, including promoting a) use of the compliance hotline, b) heightened awareness of standards of conduct, and c) understanding of new and existing compliance issues and related policies and procedures.
15+ years of experience as an attorney, including progressive responsibility for developing, implementing and managing a global compliance program within a multi-national, public company highly preferred.
5+ years of managerial experience.
Experience should clearly demonstrate competency in administering healthcare risk and compliance program functions with knowledge and demonstrated ability in the following areas:
Fraud and abuse laws, including anti-bribery/anti-corruption (“ABAC”), the Foreign Corrupt Practices Act (‘FCPA”), the UK Bribery Act and related global standards;
HIPAA and related privacy regulations;
Incentives in clinical trials;
Audits and internal investigations;
Supporting external audits and investigations of vendors and clinical trial sites;
FDA regulations related to clinical drug development;
Experience developing and implementing policies and associated training related to global compliance.
Substantial experience in a highly regulated industry, preferably pharma and/or clinical research
Juris Doctor Degree required from an accredited university.
Licensed to practice law in at least one U.S. state (active license).
Demonstrated track record of superior performance in Compliance leadership roles; a background ideally gained in a multi-national regulated company.
Clear, concise and persuasive writing and presentation skills; ability to influence senior leaders.
Strong organizational skills and an orientation to deadlines and detail; Ability to manage a diverse department and demanding workload.
Able to provide leadership and direction to an organization, yet willing to listen, take counsel and balance the interests of diverse constituencies.
Demonstrated success integrating compliance into daily operations.
Proven track record in developing, designing and implementing global policies, procedures and training in a diverse, matrix environment.
Significant experience in a global compliance program and making risk-based decisions
Ability to lead and inspire teams with and without direct line of control
The ability to work independently and to effectively deal with a wide range of personnel in rapidly changing regulatory and legal environments;
While not required, knowledge of compliance related to global sanctions and export/import regulations such as Office of Foreign Assets Control (“OFAC”), Foreign Trade Regulations (“FTR”), International Traffic in Arms Regulations (“ITAR”) and Export Administration Regulations (“EAR”) is desired.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Internal Number: 2019-59074
About PRA Health Sciences
At PRA, we don’t make our 16000+ people great. It’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do. We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do. Put simply, we care.