[EMEA] Head of Compliance

at  Santen

FUNCTIONAL QUALIFICATIONS:

• 20+ years’ experience in Pharmaceutical/Medical Device Compliance
• 10+ years’ experience of managing teams of 6+ in Pharmaceutical/Medical Device Compliance
• 10 years in a Compliance Officer role in a Pharmaceutical/Medical Device company
• Executive Leadership Team member
• In-depth knowledge of applicable regulatory and compliance requirements (i.e., UK Bribery Act, Anti-Kickback Statute, GDPR, FCPA, EFPIA, IFPMA) with an understanding of how these requirements apply to the organization’s daily operations.
• In-depth knowledge and understanding of compliance risk management practices and methodologies, including risk assessment, monitoring, and auditing activities.
• Strong project management skills, to include managing and prioritizing multiple concurrent projects, managing budgets and resources, and reporting progress and risks to colleagues and senior management.
• Preferred experience in building and implementing key components of an effective compliance program, including written standards, training, monitoring and auditing, hotline and investigations.

LEADERSHIP SKILLS:

• Ability to apply business and technical expertise to identify potential issues and partner with colleagues to help solve problems of significant importance to the company.
• Strong written and verbal communications skills, ability to act as a change agent through dynamic interactions with others. Strong negotiation skills.
• Experience leading teams to generate a vision, establish direction, motivate colleagues and employees, encourage diverse views, and encourage improvement and development.
• Strong relationship management skills: ability to build and maintain productive relationships with leaders of other functional areas within and across the business areas to seek alignment on objectives for the benefit of Company.
• Demonstrated ability to manage and prioritize multiple projects. Highly motivated with the ability to be proactive, take initiative, and carefully monitor, follow through, and complete projects in a professional and timely manner.
• Professional maturity and confidence in expressing a point of view with senior management.

EDUCATION:

• Bachelor of Science or Bachelor of Arts degree required.
• Juris Doctor preferred.
• Compliance certifications/credentials preferred.
  Additional Information

This position will play a pivotal role in shaping the future of our Compliance Organization and advancing our commitment to integrity, compliance, and ethical conduct through building a proactive compliance department that not only meets regulatory requirements but also adds value to our organization by leading our team into a new era of partnership and proactive compliance. This position will redefine the role of compliance within our organization, shifting from a traditional regulatory oversight model to one characterized by collaboration, innovation, and proactive risk management.
The successful candidate has proven experience building and operating compliance programs in both the Pharmaceutical and Medical Device industry with emphasis on leading specific teams that carry out the Proactive Compliance model. This individual understands the importance of embedding and championing compliance and ethics throughout the organization. Furthermore, the successful candidate will also have excellent communication skills and act as a change agent to engender a culture of compliance within the organization.
The Compliance Officer will partner with members of the Executive Leadership Team to ensure compliance with industry, regulatory, and Company requirements, and advise the leadership team on how to mitigate potential risks.
Job Description
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Develops and executes the annual compliance risk assessment to identify potential areas of compliance vulnerability and risk that analyzes the General Risk and Specific Risk in order to develop and implement activity specific action plans to address of problematic issues and provide general guidance on how to avoid or deal with similar situations in the future.

• Develops and maintains policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct.
• Develop, coordinate, and document a compliance training program that focuses on the elements of the compliance program, and educates employees and management on pertinent laws, regulations, and compliance expectations at Company.
• Establishes a communication plan and strategy that promotes effective lines of communication and mechanisms for employees to speak-up and report compliance concerns and potential compliance violations
• Manages the Compliance Hotline and collaborates closely with cross-functional colleagues in Legal, Human Resources, Internal Audit, Regulatory and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution as well as work towards future improvements as the Compliance Program evolves.
• Investigate allegations of violations of the company’s Code of Conduct and compliance policies and guidelines; conduct/coordinate investigations; communicate findings to the appropriate senior leadership and/or Executive Committees, as necessary. Assist in managing potential litigation and investigations related to the company’s compliance program. Establish and chair a local EMEA compliance committee to provide governance and evaluation of the company’s compliance program and any alleged violations of such program. Ensure proper reporting of violations to duly authorized enforcement agencies as appropriate or required.
• Establishes and executes a compliance monitoring and auditing plan to support ongoing evaluation of processes and related controls and to determine compliance with pertinent laws and regulations.
• Builds and leads two diverse teams of multi-disciplinary compliance professionals to execute the compliance strategy and plan. These teams consist of two distinct compliance functions:
• Corporate Compliance Assurance Team - Resources in these roles will be focused on driving centralized, coordinated development and enhancement of Compliance Program operational elements for the region
• Business Compliance Partner Team - Resources in these roles will focus on directing and coordinating front-line engagement and compliance risk management advisory support to the business.
• Regularly reports compliance matters to Company’s leadership and Compliance Committee and collaborates with Company’s Executive Leadership Team to establish methods and plans to address and mitigate compliance risks.
• Medical Device Compliance: Proven track record of building a Compliance Program that includes guidance, SOPs, training and monitoring, specific to Medical Device activities such as customer training programs, surgical interactions, products compliance (demonstration, replacement, evaluation, no charge, etc.), commercial transactions, and patient organization interactions.
• Medical, R&D and Clinical Compliance: Build compliance program activities related to the Medical, R&D and Clinical departments. This includes a deep understanding of activities such as MSL interactions, Medical Information Requests, Clinical trial elements, publications, Grants, protocols, and all other potential risks around the Medical, R&D and Clinical Organizations.
• Middle East and Africa: Extensive background in leading Pharmaceutical and Medical Device Compliance in the Middle East and Africa, specifically in codes governing advertising and promotions such as UAE Code of Pharmaceutical Marketing Practices, UAE MoHAP PHRMAG, SFDA, Mecomed Code, Middle East and Africa Code of Practices (MEACPP) and other relevant governing codes in that region.

Qualifications