The Director, Commercial Healthcare Compliance develops and implements strategy and is accountable and responsible for leading the healthcare compliance program for commercial functions in the US (including Sales, Marketing, Health Systems, product-specific therapeutic areas and client groups, and commercial operations) and providing global matrix support for the global Marketing Strategies function in close collaboration with the Executive Director, Healthcare Compliance, Monitoring & Investigations, Americas. The Director is a strong leader and promotes a highly ethical, compliant and accountable culture that encourages and enables employees to raise potential or actual compliance concerns.
Essential Job Responsibilities:
Key accountabilities and responsibilities include the following in close collaboration with and at the direction of the Executive Director, Healthcare Compliance, Monitoring & Investigations, Americas:
- Effectively implements global and US-specific compliance standards through strategic planning, oversight and effective communication, training and monitoring of policies, controls and initiatives across commercial functions in the US and as part of matrix support for global Marketing Strategies.
- Develops and leads strategies to ensure adherence to Company policies relating to commercial healthcare compliance in the US. Responsible for developing a team of commercial Healthcare Compliance experts. Develops strategies and leads implementation of strategies to continually enhance and maintain a highly ethical, compliant and accountable culture.
- Leads and develops strategies for the commercial Healthcare Compliance program in alignment with strategic business models and the external healthcare landscape. Provides sophisticated ethics and compliance guidance for key strategic business teams/initiatives. Regularly meets with senior business leaders and participates in, influences and provides advice for strategic business models, projects and initiatives. Develops and leads the strategy for Ethics and Compliance support for new product launch initiatives.
- Develops and implements strategies for and leads collaboration with the business to embed a strong culture of compliance, accountability and consequences for non-compliance. Develops strategies for, leads and is accountable for continually enhancing business ownership of controls and systems designed to ensure adherence with the Company’s ethical and compliance standards.
- Develops strategy for and oversees and leads support at key business meetings, including national leadership forums, national sales forums, and product launch meetings. Oversees timely, consistent and effective compliance guidance, direction and support for commercial field teams.
- Develops strategy for and oversees and leads healthcare compliance projects/initiatives in alignment with a global ethics and compliance focus and interacts closely with local, regional and global Ethics & Compliance teams to ensure adherence to laws, regulations, industry codes, policies, processes and to promote best practices.
- Develops strategy for and leads the continuous assessment and enhancement of the healthcare compliance program relating to client groups in close collaboration with business stakeholders, and makes recommendations to local, regional and global Ethics & Compliance leaders as appropriate for opportunities for enhancement.
- Coordinates and collaborates closely with the non-commercial Healthcare Compliance team in order to develop strategies for effective integrated healthcare compliance program consistent with global strategies/policies/processes; ensures that the Ethics & Compliance support is well coordinated, responsive to the business and in adherence with the Company’s ethical and compliance standards.
- Leads and develops strategies for Ethics & Compliance support in the development and execution of promotional strategies and activities, including the review and approval of Astellas-sponsored activities, annual brand plans and speaker bureaus/programs. Attends Material Approval Process meetings as appropriate.
- Continually evaluates and identifies needs relating to compliance training and education for client groups. Provides strategic input into the design, development, implementation and delivery of innovative compliance training materials, communications, presentations, workshops and systems, as well as developing content and delivering and leading presentations and workshops with the business. Facilitates business involvement and input from the client groups in compliance training and communication development.
- Develops strategy for and leads collaboration with business partners on commercial healthcare compliance matters. Supports due diligence and integration of merged, acquired or collaboration partner entities.
- Partners with local, regional and global monitoring teams to share insights, observations and knowledge of ongoing and developing business strategies/initiatves/activities in order to ensure learnings are incorporated into the monitoring activities at the local, regional and global level and to ensure that any corrective actions and/or enhancements are tailored to ensure highly ethical and compliant business conduct. Also participates in the development and execution of live and transactional monitoring activities.
- Coordinates and collaborates with the local, regional and global operations teams with respect to the auditing, monitoring, training and communications needs of the business, including proactively identifying such needs and opportunities for enhancement, and developing and implementing appropriate training and education programs.
- Collaborates with cross-functional teams locally, regionally and globally to influence the commercial Healthcare Compliance strategy to ensure alignment with US standards and support development and expertise within Ethics & Compliance.
- Researches, benchmarks, stays current and maintains sophisticated knowledge of applicable legal and regulatory developments, industry standards, Company business strategies and the changing healthcare landscape to determine emerging compliance trends and incorporates such developments, standards and trends into education for the Ethics & Compliance team as well as the compliance strategies and advice provided to the business.
- Leads and participates in other Ethics & Compliance initiatives deemed necessary to further enhance Astellas’ commitment to high ethical standards and compliance with the law.
Responsible for operating within the regional compliance budget, and any applicable project specific budgets.
- Directly reports to the Executive Director, Healthcare Compliance, Monitoring & Investigations, Americas
- Works closely and collaborates with Ethics & Compliance regional leadership and operations.
- Collaborates with team members via matrix global organization for the Marketing Strategies function and manages a team of at least four reports
- Leads and ensures the effective implementation of the commercial Healthcare Compliance program in the US and closely coordinates with Ethics & Compliance counterparts across the globe
- Works closely and collaborates with business leadership in the US.
- Minimum of 10 years experience in Ethics & Compliance or related functions (e.g., regulatory, legal, audit, or risk).
- Expertise in compliance with the laws, regulations and industry codes relevant to the pharmaceutical industry in the US. Sophisticated knowledge of best practices relating to compliance in highly regulated industries.
- Proven ability to lead high-level, broad-based objectives in the context of annual compliance objectives.
- Strong analytical, organizational, problem solving, and follow-up skills. Ability to interpret rules and guidelines, and ability to conceptualize policies, procedures and controls.
- Ability to self-start and self-direct work in a fast-paced environment.
- Excellent project management skills. Ability to prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data.
- Excellent written and verbal executive-level communication skills.
- Adaptability necessary to work effectively in a sometimes ambiguous, changing, and matrix global environment.
- Ability to demonstrate sound and independent judgment, prudence and maturity in complex and sensitive cases.
- Client orientation with a constructive approach to resolution of issues. A style which builds alliances within the organization, locally/globally, and/or corporate collaborators.
- Advanced degree (Juris doctor; Masters; Ph.D) or advanced compliance certifications (CCEP or equivalent).
- Experience working globally