Director, Compliance, Spain and Portugal

The Opportunity:

RevMed is seeking an experienced compliance leader in Spain and Portugal. As a key member of the Legal and Compliance function, this is an excellent leadership opportunity to enable the launch of new RevMed therapies and the Company’s rapid business growth in Spain. 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.

Experience:

An experienced compliance professional, ideally with a legal qualification. You are likely to have 10+ years’ experience in-house pharmaceutical experience and a strong track record of setting up and leading a local or regional healthcare compliance framework.  You must be able to demonstrate strong experience across all compliance pillars and be a strong communicator and team player. 

Key Responsibilities

Key responsibilities of this role include the following:

• Program Development and Strategic Alignment: Lead the continuous development of the Healthcare Compliance Program in Spain and Portugal in line with RevMed’s global compliance strategy. Ensure the program is consistent with the values and principles of the organization, fit for purpose, and complies with applicable Spanish laws, regulations and industry codes.

• Local Business Advisory: Represent Compliance on the Spanish Leadership team and serve as the primary compliance advisor to the local Commercial and Medical teams, providing risk-based guidance across the product life cycle to enable successful launches and commercialization.

• Cross-Functional Collaboration: Collaborate across functions and regions to adapt and implement global compliance initiatives in Spain.

• Activity Review and Certification: Provide compliance oversight of the review and approval of interactions with HCPs, HCOs, patient organizations, payors and government officials (including grants, sponsorships, speaker programs and advisory boards), and of the certification of promotional and non-promotional materials and meetings.

• Regulatory & Code Monitoring: Proactively monitor and interpret legal, regulatory and industry-code developments in Spain, including developments under the Spanish Criminal Code provisions on corporate criminal liability (including Article 31 bis) and applicable criminal compliance models, Royal Legislative Decree 1/2015 (Medicines Law), Royal Decree 1416/1994 on advertising of medicinal products, and the Farmaindustria Code of Good Practice and its transparency and disclosure requirements, and advise the business on their operational impact.

• Policies and Procedures: Draft, implement and update compliance policies, procedures and guidance to ensure compliance with applicable laws, regulations and industry codes in Spain.

• Training: Develop, deliver and monitor a comprehensive compliance training program for employees in Spain, including field-based personnel, and designated third parties.

• Compliance Culture: Foster a strong culture of compliance and integrity across the Spanish organization.

• Systems and Process Innovation: Provide healthcare compliance subject matter expertise in developing compliance systems, tools and technology solutions that improve the efficiency and effectiveness of the program for common HCP interactions.

• Monitoring, Auditing and Risk Assessment: Design and execute the risk assessment, monitoring and auditing plan for Spain, and lead remediation where necessary.

• Investigations and Speak-Up: Administer local whistleblowing channels and support compliance investigations, including corrective and preventive action plans.

• Third-Party Risk Management: Own risk-based due diligence and ongoing monitoring of third parties (distributors, agencies, consultants and vendors) under applicable anti-corruption and transparency requirements.

• Reporting and Transparency: Support the Compliance Committee and transparency reporting obligations, including Farmaindustria transparency and disclosure requirements, and provide regular compliance reports to the Compliance Committee, Commercial Leadership, Medical Affairs and country management.

• Stakeholder Liaison: Act as compliance liaison with the AEMPS, regional health authorities, Farmaindustria and its Code Surveillance Unit, managing responses to code complaints, inquiries and investigations.

Required Skills, Experience and Education:

• 10 years’ relevant experience, including in-house pharmaceutical experience developing compliance programs.

• Demonstrated track record of working successfully as an individual contributor while managing a wide range of stakeholders and client groups, building compliance capabilities in a scaling organization without direct reports.

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

• Comprehensive knowledge of Spanish anti-corruption and healthcare compliance laws, including the Spanish Criminal Code provisions on corporate criminal liability (including Article 31 bis) and applicable criminal compliance models, Royal Legislative Decree 1/2015 (Medicines Law), and Royal Decree 1416/1994 on advertising of medicinal products; Spanish transparency and disclosure requirements; and applicable industry codes, including the Farmaindustria Code of Good Practice.

• 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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