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Astellas is announcing a Director, Ethics & Compliance Regional Investigations Lead opportunity in Northbrook, IL.
Purpose & Scope:
The Director, Ethics & Compliance Regional Investigations Lead (the "Director") has a key position within the Ethics & Compliance organization with a focus on regional oversight and management of internal Compliance Investigations (investigations where the allegations involve a potential violation of company policies, procedures, standards or external rules & regulations related thereto) and internal and external Code investigations. This position has accountability and oversight responsibilities relating to region-specific investigations activities/customizations and drives effective implementation of the global Investigations program across the region. .
The Director is responsible for:
* Supporting the Executive Director, Ethics & Compliance Investigations Lead (the "Executive Director") in formulating and implementing practical guidance on how to manage and resolve Compliance Investigations;
* Proactively identifying potential risk areas, supporting the development of best practice processes and recommending creative options and courses of action in a manner that fosters the Company's business interests, advances the Company's goals and minimizes risks on a regional and local Affiliate level;
* Coordinating and closely collaborating with regional Legal counterparts with respect to Legal-led Compliance Investigations and legal actions or claims that arise out of other Compliance Investigations;
* Leading and overseeing a regional Ethics & Compliance (E&C) Investigations Team to provide practical, timely, high quality review, resolution, and reporting of Compliance Investigations on a regional and local Affiliate level;
* Providing guidance related to Compliance Investigations to E & C personnel and the business across the region;
* Recommending preventative measures based on root cause analyses from Compliance Investigations in order to prevent prospective financial or reputational harm; and
* Assisting the Executive Director in reporting to senior management and other stakeholders as appropriate.
Essential Job Responsibilities:
Under the direction of and in close coordination with the Executive Director, the Director has primary responsibilities to:
* Manage, oversee and conduct Compliance Investigations at the regional and local Affiliate level, taking into account local laws, customs and practices as appropriate;
* Work with cross-functional stakeholders on risk mitigation strategies based on observations of Compliance Investigations regionally;
* Coordinate and work closely with the regional and local Affiliate members of Ethics & Compliance;
* Manage the regional E & C Investigations Team and ensure consistent use of best practices and a high standard of professional excellence;
* Identify key compliance issues and risks requiring attention from the Vice President, Regional Head of Ethics & Compliance, as appropriate;
* Prepare, oversee and manage the budget for the Regional E & C Investigations Team, including management of third-party vendor fees consistent with applicable budgets;
* Work collaboratively with a broad range of people and functions throughout the organization to develop and maintain strong working relationships across all functional areas to facilitate a partnering-based approach;
* Work collaboratively with Internal Audit and Audit & Supervisory Committee members in conjunction with the Director, Regional Operations;
* Work collaboratively with Legal counterparts at the regional and local Affiliate levels;
* Oversee investigations training for the Regional Ethics & Compliance Investigations Team, Ethics & Compliance personnel and Astellas personnel as appropriate;
* Identify training needs within client groups and assist in the development and presentation of training for such issues;
* Support the management of the Monthly Compliance Disclosure Log, including supporting the Director, Regional Operations, with compiling statistics, generating reports, and making presentations regarding the Global Compliance Hotline to senior management;
* Other projects as may be requested by the Executive Director.
* Responsible for operating within the regional Ethics & Compliance budget, and any applicable project specific budgets.
* Reports to the Executive Director, Ethics & Compliance Investigations Lead;
* The Director will be supported by a team of two dedicated Ethics & Compliance Investigators within the region;
* Works closely and collaborates with leadership at both regional and local Affiliate levels;
* Works closely and coordinates with the Regional Head of Ethics & Compliance as well as functions such as Human Resources ("HR"), Internal Audit ("IA"), and Information Systems ("IS").
* Extensive 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 region.
* Significant 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.
* 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/regionally, and/or corporate collaborators.
* Domestic and international travel anticipated (approximately 25%).
* 8-10 years' experience in Ethics & 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).
* Experience working globally.
* Experience living & working in a country other than your native country.
* Fluent English and proficient skills in another language.
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created Changing Tomorrow Day, an annual, worldwide volunteer event, to demonstrate this commitment.