Purpose & Scope:
The Senior Director, Healthcare Compliance, US Medical Affairs, and US Technology develops the strategy and is accountable and responsible for leading the healthcare compliance program for Medical Affairs function in the US, and part of global matrix support for these functions in close collaboration with the Executive Director, Healthcare Compliance, Development & Research. The Senior 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, HCC, E&C, Development, Research, Innovation:
- Effectively implementing the global and US-specific compliance standards through strategic planning, oversight and effective communication, training and monitoring of policies, controls and initiatives across US Medical Affairs.
- Develops strategy for, oversees and leads healthcare compliance projects/initiatives for US Medical Affairs in alignment with a global ethics and compliance focus and interacts closely with local, divisional and global Ethics & Compliance teams to ensure adherence to laws, regulations, industry codes, policies, processes and to promote best practices.
- Responsible for setting compliance strategy for complex technology areas and for making strategic independent decisions, requiring the ability to both recognize issues and develop creative solutions to drive results for the Company.
- Develops strategy for and leads the continuous assessment and enhancement of the healthcare compliance program for US Medical Affairs in collaboration with business stakeholders, and makes recommendations to divisional and global Ethics & Compliance leaders for opportunities for enhancement.
- Develops and leads strategies to ensure adherence to Company policies relating to non-commercial healthcare compliance at the regional and local level. Develops strategies for and leads implementation of strategies to continually enhance and maintain a highly ethical, compliant and accountable culture.
- Leads the provision of ethics and compliance guidance for key strategic business teams/initiatives. Regularly meets with senior business leaders and participates in and provides advice for strategic business projects/initiatives. Member of Medical Affairs US leadership team where this Senior Director provides ethics and compliance advice about Medical Affairs strategy and initiatives on a regional and local level.
- Coordinates and collaborates closely with the Commercial Healthcare Compliance team in order to develop strategies for effective integrated healthcare compliance program in the region and at a local level consistent with global strategies/policies/processes; ensures that the ethics and compliance support is well coordinated, responsive to the business and in adherence with the Company's highest ethical and compliance standards.
- Provide strategic leadership, counseling, advice, training, and support related to compliance, quality policy and practice, and other related compliance implications for the enterprise, including support for Medical Affairs, Field Medical (i.e., Medical Science Liaisons, Physicians, Nurse Educators, and Managed Markets)
- Support publication policy, process, systems, and oversight to deliver timely, high impact dissemination of key publications for company's research and key therapeutic areas to target audiences, including clinical and non-clinical publications.
- Develops strategies for and ensures effective implementation, maintenance and continuous enhancements of controls (processes and systems) relating to the review and approval of Medical Affairs interactions with HCPs and/or HCOs.
- Develops strategy for and leads collaboration with business partners on Medical Affairs healthcare compliance matters in the US. Responsible for due diligence and integration of merged, acquired or collaboration partner entities, as assigned.
- Collaborates with US monitoring team to share insights, observations and knowledge of ongoing and developing business strategies in order to ensure learnings are incorporated into the monitoring activities at the local and regional level and to ensure that any corrective actions and/or enhancements are tailored to ensure highly ethical and compliant business conduct.
- Collaborates with cross-functional teams locally, divisionally and globally to influence the Healthcare Compliance strategy to ensure alignment with the US and support development and expertise within Ethics & Compliance.
- Researches, benchmarks and stays current with applicable legal and regulatory developments, industry standards and the changing healthcare landscape to determine emerging compliance trends and incorporates such developments, standards and trends into education for the non-commercial healthcare compliance team at the regional and local level as well as the compliance strategies and advice provided to the business.
- Coordinate and collaborate 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.
- Develops and implements strategies for and leads collaboration with the non-commercial business to embed a culture of compliance, accountability and consequence for non-compliance.
- 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, E&C, HCC, Development, Research, Innovation, US MA, and US Technology Lead.
- Works closely and collaborates with Ethics & Compliance global and regional leadership, operations and Anti-bribery and Anti-corruption lead
- Leads and ensures the effective implementation of the Healthcare Compliance program in the US and closely coordinates with Ethics & Compliance counterparts across the globe
- Works closely and collaborates with senior leadership of all functions across the US
- Minimum of 10 years experience in Compliance or related functions (e.g., regulatory, legal, audit, or risk).
- Advanced degree (Juris doctor; Masters; Ph.D) or advanced compliance certifications (CCEP or equivalent).
- Expertise in compliance with law, regulations and industry codes relevant to the pharmaceutical industry. Significant knowledge of the 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.
- Demonstrated experience leading compliance operations projects and activities in a matrixed, global organization.
- Excellent written and verbal executive-level communication skills.
- Adaptability necessary to work effectively in a sometimes ambiguous, changing, and matrix global environment.
- Exceptional ethics and commitment to integrity, interpersonal skills, professionalism, and collegiality.
- Does not confuse effort for results.
- Tenacity to weather short-term setbacks for long-term advantages.
- 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.