Executive Director, Europe, Compliance

The Opportunity:

RevMed is seeking an experienced compliance leader in Europe. As a key member of the Legal and Compliance function, this is an excellent opportunity to lead a team and support the launch of new RevMed therapies and the Company’s rapid business growth in Europe. The position will contribute to the development and implementation of organizational strategies, policies and practices, and work with senior Commercial, Medical, Clinical Development, Legal, Finance and HR leadership to integrate appropriate healthcare, corporate and other compliance controls to guide the Company’s operations.

Key Responsibilities

• Lead continuous development of Healthcare Compliance Programs in Europe in line with RevMed’s global compliance strategy, the OIG Compliance Program Guidance for Pharmaceutical Manufactures (OIG Guidance), applicable industry codes and best practices.

• Build and manage a team of European Compliance Officers to support country specific business departments.

• Lead the buildout of European Compliance Operations to support European business initiatives.

• Represent Compliance as the Compliance lead on the European Leadership team.

• Collaborate with cross-regions and implement global compliance initiatives in Europe.

• Proactively identify legal and regulatory issues, industry trends, industry codes and practices applicable to compliance.

• Advise on the adoption of new, or revision of existing, policies and procedures to ensure compliance with laws, regulations and applicable industry codes globally and regionally.

• Develop and monitor the execution of a comprehensive compliance training program for Europe employees and designated third parties on applicable compliance policies, laws and regulations.

• Foster a culture of compliance and integrity in the region.

• Provide compliance leadership and oversight for review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations, governments, and patient advocacy groups.

• Provide healthcare compliance subject matter expertise in the development of appropriate systems, tools and technology solutions to enhance the efficiency and effectiveness of the Healthcare Compliance Program relating to common HCP interactions, such as advisory boards, consulting engagements, speaker programs, sponsorships and grants.

• Collaborate with the Head of Compliance on the design and execution of internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the Company identifies potential compliance risks and remediates where necessary.

• Support Head of Global Compliance in the conduct and resolution of compliance investigations as needed, including the implementation of corrective and preventive actions plans.

• Establish and chair the Compliance Committee in Europe; Provide regular compliance related reports and other communications for multiple audiences in the Company, including the Compliance Committee, Commercial Leadership, Medical Affairs teams, and country management teams.

• Support Head of Global Compliance in the conduct and resolution of compliance investigations as needed, including the implementation of corrective and preventive actions plans.

• Proactively identify legal and regulatory issues, industry trends, industry codes and practices applicable to compliance.

• Partner with the Head of Global Compliance to build, develop, and manage the European compliance team, including hiring, onboarding, performance management, mentoring, and establishing scalable operating models to support the Company’s growth in Europe.

• Advise on the adoption of new, or revision of existing, policies and procedures to ensure compliance with laws, regulations and applicable industry codes globally and regionally.

• Develop and monitor the execution of a comprehensive compliance training program for Europe employees and designated third parties on applicable compliance policies, laws and regulations.

• Foster a culture of compliance and integrity in the region.

Required Skills, Experience and Education:

• Minimum of 14 years’ relevant experience including in-house pharmaceutical experience developing compliance programs.

• Experience managing people, teams and dotted-line reports  

• Extensive experience with compliance matters relating to the development, approval and commercialization of pharmaceutical products in Europe.

• Comprehensive knowledge of healthcare fraud and abuse laws and transparency requirements as well as industry codes in European countries.

• Ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations.

• Strong critical thinking skills, attention to detail, adaptability, communication skills and professionalism.

• Ability to work in a matrix organization, collaborate with business partners, influence peers and interact with both senior management and Field Force, Medical and Market Access teams.

• Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations.

• Exceptional and demonstrated written and verbal communication skills and interpersonal skills in both one-on-one and group settings, as well as proven negotiation skills.

• Excellent organizational skills and problem-solving capabilities and the ability to perform in a fast-paced, high volume, deadline-driven environment.

• Confidence to advise stakeholders at all levels.

• Appropriate judgment to liaise with Legal and business colleagues and/or outside counsel as needed.

• Commitment to being a team player with the desire to be helpful in other areas covered by a growing Compliance department.

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