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Associate Director, Ethics & Compliance  

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 an Associate Director, Ethics & Compliance in Northbrook, IL.


Purpose & Scope:

Provide compliance support and serve as a resource to the U.S. Commercial organization, including without limitation: (1) Sales & Marketing; (2) product-specific therapeutic areas and client groups; and (3) the various functions supporting these areas and client groups, including Astellas related entities, affiliates and business partners, as applicable. Serve as a primary compliance resource for assigned therapeutic areas and client groups. Play a key role in the development and implementation of compliance strategies, tactics and materials, and provide direct support and advice to help clients adhere to the Company's highest ethical and compliance standards through all stages of product lifecycle management.


This position also will participate in and lead cross-functional project teams and support Ethics & Compliance leadership in developing and implementing strategic initiatives to enhance compliance policies, processes and controls.


Essential Job Responsibilities:

Provide compliance support and serve as a resource for assigned therapeutic areas and client groups within the U.S. Commercial organization, the various functions supporting the assigned client groups, and Astellas' related entities, affiliates and business partners. Ensure inclusion and integration of compliance support and strategies through all stages of product lifecycle management, from pre-launch planning to loss of commercial exclusivity. Participate in and lead cross-functional project teams in support of business strategic initiatives.

* Conduct needs assessments to proactively identify compliance support needs and opportunities for the assigned client groups, identify potential risk areas, and play a key role in development and execution of strategies to address identified risks and needs, including compliance controls, policies, processes, training and communication.

* Provide compliance support to the assigned client groups in the development and execution of promotional strategies, tactics and materials, including Astellas-sponsored events, programs and activities. Participate in the review of Company-sponsored meetings, programs, events and sponsorships, annual brand plans and speaker bureau justifications. Attend Material Approval Process (MAP) meetings, as appropriate, develop and implement guidelines and controls, and partner with Commercial Learning & Development (CL&D) and Sales leadership to ensure appropriate training of customer-facing teams.

* Work closely with Astellas co-promotion partners and internal stakeholders (including Marketing, Sales, Legal and Alliance Management), as appropriate, to ensure awareness, alignment and consistency on compliance policies and process, including fair market value (FMV), meeting logistics, exception requests, etc.

* Respond to compliance inquiries originating from, and relating to, the assigned client groups, provide timely and sound compliance advice, and develop and implement compliance solutions to meet those needs and opportunities in accordance with Astellas' high ethical and compliance standards, collaborating where appropriate, with others within the Ethics & Compliance department.

* Proactively identify compliance training and education needs for the assigned client groups, and participate in the development, implementation and delivery of innovative compliance training materials, communications, presentations, workshops and systems. Facilitate involvement and input from the client groups in compliance training and communication development.

* Contribute to the development and implementation of long-range strategic plans and initiatives to enhance compliance policies processes and controls. Collaborate with others in the Ethics & Compliance department to address issues and identify opportunities for collaboration, alignment, process improvement and best practice sharing.

* Attend and participate in Astellas Sales and Marketing meetings, including the National Sales Forum, the Leadership Forum, POA meetings, Area and Regional sales meetings, and product launch meetings. Develop and deliver compliance presentations and participate in main stage and smaller group training, workshops, breakouts, etc.

* Conduct live monitoring of Company events, programs and activities, including interactions with HCPs, advisory boards, consultant meetings, medical congresses, and promotional speaker programs, and support implementation of appropriate corrective action, where necessary. Conduct and support transactional monitoring, as requested, in collaboration with the Ethics & Compliance Monitoring team.

* Support internal compliance investigations, including matter intake, and recommending and helping to implement corrective action, including enhanced policies, processes, training and communication. Collaborate with client management, Human Resources and Legal, as appropriate, to address specific compliance issues.

* Other duties as assigned.


Quantitative Dimensions:

* Establish a strong and visible compliance presence within the assigned therapeutic areas and client groups in the U.S. Commercial organization

* Provide compliance support for multiple therapeutic areas/client groups, and approximately 800 field-based employees

* Develop and implement compliance policies, processes, systems and controls

* Conduct at least 2 compliance training sessions per client group/year

* Conduct ongoing monitoring of related to client activities, events and programs

* Respond to 250+ compliance inquiries/year


Organizational Context:

Reports to the Executive Director, Healthcare Compliance and Risk Mitigation. Position typically interacts with corporate and field-based employees up to the Vice President level within assigned therapeutic areas and client groups in the Astellas U.S. Commercial organization, as well as with other functions, such as Legal, Human Resources, Finance, Government Affairs, and Corporate Communications, and external business partners, as applicable.







* Bachelor's Degree in a healthcare-related discipline, life sciences, law or business, or equivalent experience

* 10+ years of related experience

* Minimum of 5 -- 7 years' experience in the pharmaceutical industry

* Knowledge of and experience in industry compliance issues impacting sales, marketing and managed markets/health systems

* Demonstrated team 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, presentation, teaching and coaching skills. 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 with little or no supervision, and manage multiple projects simultaneously

* Strong work ethic and ability to produce high quality work under deadline pressures



* J.D., MBA or other advanced degree strongly preferred

* Prior experience effectively managing one or more direct reports



Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Type Full-time
Location IL, Northbrook
Category Ethics and Compliance

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