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Astellas Pharma Director, E&C Investigations Lead in Northbrook, Illinois

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Director, Ethics & Compliance Investigations Lead (the "Director") is responsible for strategic execution, 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 involving a wide variety of Astellas-sponsored activities and functions in assigned divisions and affiliates. Work includes intake and assessment of compliance reports; planning and conducting Compliance Investigations and root cause analyses; tracking, trending and reporting investigation metrics and observations; developing and supporting implementation of strategies to address and mitigate identified compliance risks; and training, development and management of investigations personnel. This position has accountability and oversight responsibilities relating to investigation activities/customizations in assigned area of responsibility and plays a key role in driving effective implementation of the global Investigations Program.

The Director is responsible for:

  • Supporting the Vice President, Head of Compliance Investigations, Third Party, ABAC & Distributor Compliance Risk (the "Vice President") in formulating and implementing strategies and practical guidance to successfully manage, conduct 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 identified and emerging compliance risks;

  • Coordinating and closely collaborating with Astellas Legal counterparts with respect to Legal-led Compliance Investigations and legal actions or claims that arise out of other Compliance Investigations;

  • Leading, developing and overseeing an Ethics & Compliance (E&C) Investigations Team to provide practical, timely, high quality review, resolution, and reporting of Compliance Investigations in assigned areas of responsibility;

  • Providing subject matter expertise and guidance related to Compliance Investigations to E&C personnel and the business in assigned areas of responsibility;

  • Recommending mitigation and preventative measures based on root cause analyses from Compliance Investigations in order to prevent prospective compliance risks, financial impact or reputational harm; and

  • Assisting the Vice President in tracking, trending and reporting investigation metrics and observations to senior management and other stakeholders as appropriate.

Essential Job Responsibilities:

  • Under the direction of and in close coordination with the Vice President, the Director has primary responsibilities to:

  • Strategically manage, oversee and conduct Compliance Investigations that involve a wide variety of Astellas-sponsored activities and functions in assigned divisions and affiliates, including without limitation, investigations involving the Astellas Commercial, Medical Affairs, Research & Development and General & Administration organizations, taking into account local laws, customs and practices as appropriate;

  • Work closely with cross-functional stakeholders to conduct root cause analyses, develop and implement risk-based mitigation strategies, and ensure that Compliance Investigation findings and observations are integrated and enabled into compliance and business policies, processes, training and communication to most effectively mitigate risk;

  • Coordinate and work closely with other members of Ethics & Compliance on Compliance Investigations and related issues within their areas of responsibility, including members of the Ethics & Compliance Extended Leadership Team, the Compliance Excellence and Transformation (CET) team, and employees within the local affiliates;

  • Work collaboratively with Legal counterparts as appropriate in the planning, conducting, managing and reporting of Legal-led Compliance Investigations in assigned areas of responsibility, as well as legal actions or claims that arise out of Compliance Investigations;

  • Manage and oversee an E&C Investigations Team in the assigned areas of responsibility and ensure consistent use of best practices and a high standard of professional excellence;

  • Ensure timely and accurate tracking of Compliance Investigation activity in assigned areas of responsibility, including documentation of investigation strategy, factual findings and observations, root cause analyses, and determination and completion of corrective actions and risk mitigation activities;

  • Lead the development and management of the Monthly Compliance Disclosure Log, including supporting the Vice President with compiling statistics, generating reports, and making presentations regarding the Global Compliance Hotline to senior management;

  • Develop, manage and support the preparation and delivery of periodic reports on Compliance Investigation metrics, trends and activities to key stakeholders, including applicable Boards of Directors, Compliance Committees, business management teams, and/or other reporting needed to comply with regulatory requirements, government guidelines and avoid government penalties.

  • Strategically develop and implement policies, processes, training and communications necessary to enhance the overall efficiency, effectiveness and continued optimization of the global Investigations Program, including development and delivery of periodic training for the global Investigations Team;

  • Prepare, oversee and manage the budget for Compliance Investigations in assigned areas of responsibility, 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 Astellas Internal Audit, Audit & Supervisory Committee members and external corporate auditors in conjunction with the Vice President;

  • Stay current on industry compliance trends through industry publications and literature, benchmarking and consulting with industry counterparts, attending industry conferences, continuing education programs, and similar activities; and

  • Other projects as may be requested by the Vice President.

Quantitative Dimensions:

  • Responsible for operating within the approved Ethics & Compliance budget and any applicable project specific budgets.

Organizational Context

  • Reports to the Vice President, Head of Compliance Investigations, Third Party, ABAC & Distributor Compliance Risk;

  • The Director will be supported by a team of up to two dedicated Ethics & Compliance Investigators within the assigned areas of responsibility, as well as matrixed support from other members of the global Investigations Team on assigned Compliance Investigations and projects;

  • Works closely and collaborates with leadership at global, divisional and local affiliate levels;

  • Works closely and coordinates with members of the Ethics & Compliance Extended Leadership Team, as well as functions such as Human Resources ("HR"), Internal Audit ("IA"), and Information Systems ("IS").

Qualifications Required

  • 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 assigned area of responsibility.

  • 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 (up to approximately 25%).

  • Bachelor's Degree

Qualifications Preferred

  • 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 and working in a country other than your native country.

  • Fluent English and proficient skills in another language.

Benefits

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.

*LI-CH1

Category Ethics and Compliance

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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