Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Director, Ethics and Compliance Commercial opportunity in Northbrook, IL.
Purpose & Scope:
The Director, Ethics & Compliance Commercial plays a key role in developing strategy, implementing and leading the healthcare compliance program for the Patient Centricity team, RX+, Digital, and Advanced Informatcis & Analytics (AIA) in close collaboration with the Executive Director, Healthcare Compliance, Xtandi, US Commercial & Risk Mitigation. 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:
Effectively implementing the global compliance standards through strategic planning, oversight and effective communication, training and monitoring of policies, controls and initiatives with the designated functions.
Develops strategy for, oversees and leads healthcare compliance projects/initiatives for enterprise-wide strategic initiatives and imperatives, including but not limited to Patient Centricity, RX+, Digital, and data governance/knowledge management initiatives, through the definition and deployment of business specific compliance standards and controls, policies, processes, interaction guidelines, training, communications and robust monitoring plans locally, regionally and globally.
Develops strategy for and leads the continuous assessment and enhancement of the healthcare compliance program for designated functions in collaboration with business stakeholders, and makes recommendations to global Ethics & Compliance leaders for opportunities for enhancement.
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.
Coordinates and collaborates closely with the Commercial and Non-commercial Healthcare Compliance teams in order to develop strategies for effective integrated healthcare compliance program in the division 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 timely and sound guidance, advice, direction and support to business stakeholders about the policies, procedures and processes that govern their interactions with commercial and non-commercial functions.
Partner with internal oversight functions, including the Ethics & Compliance monitoring team and Internal Audit, to develop and implement effective auditing and/or monitoring plans these activities, including the delivery of reports and metrics.
Partner with Ethics & Compliance and Legal colleagues, globally, to proactively address issues and identify opportunities for collaboration, alignment, process improvement and best practice sharing and implementation.
Implement compliance strategy and support for Advanced Informatics & Analytics (AIA) including providing workable and scalable guidance to encourage the compliant development and implementation of new data governance and knowledge management initiatives on a global scale.
Collaborates with cross-functional teams globally to influence the Healthcare Compliance strategy to ensure alignment globally 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.
Contribute to the development and implementation of long-range strategic plans to advance Ethics & Compliance.
Other special projects and responsibilities as assigned.
Establish a strong and visible compliance presence with the client's organizations.
Ensure systems, policies and processes are effective and efficient.
Develop strategy, content and conduct compliance training for client groups.
Develop and conduct ongoing monitoring of client activities, events and programs.
Provide timely and appropriate responses to client requests and inquiries.
7+ years of related work experience.
4+ years of pharmaceutical and/or healthcare industry experience.
Knowledge of and experience in developing and implementing processes and systems that govern transactions and approval workflow.
Strong leadership skills and strategic focus. Demonstrated ability to exercise independent judgment, effectively collaborate with multiple functional units, lead without authority, exercise tact and discretion in assessing compliance needs, and to respond timely and accurately to compliance inquiries.
Excellent oral and written communication and presentation skills required. Ability to effectively communicate compliance issues verbally and in writing in a clear and understandable manner. Demonstrated ability to inspire trust and confidence through effective communication and interpersonal skills.
Demonstrated ability to be proactive, identify and focus on critical priorities and manage multiple projects simultaneously.
Strong work ethic and ability to produce high quality work under deadline pressures.
Prior compliance experience is preferred.
Masters or other advanced degree is preferred.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Astellas Pharma US, Inc.