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Astellas Pharma Assistant Director, Ethics and Compliance, Research and Innovation in Northbrook, Illinois

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 Assistant Director Ethics and Compliance, Research and Innovation opportunity in Northbrook, IL.

Purpose & Scope:

This position will provide compliance direction and support to Medical Affairs & Development (M&D), the departments supporting these functions and Astellas's global entities, affiliates and business partners. The individual will serve as a principle compliance resource for these clients, assist in the development and implementation of compliance strategies, tactics and materials, and will be responsible for providing direct support and advice to help clients adhere to the Company's highest ethics and compliance standards.

Essential Job Responsibilities:

  • Provide compliance support and serve as a resource to Medical Affairs & Development (M&D), the departments supporting these functions and Astellas' related entities, affiliates and business partners, with focus on compliance risk areas such as clinical research, scientific and medical publications, scientific meetings and other interactions and engagements with healthcare professionals (HCPs) and healthcare organizations (HCOs)
  • Proactively identify his/her clients' compliance needs and opportunities, respond to his/her client's compliance inquiries, provide timely and sound compliance advice and develop and implement solutions for meeting those needs and opportunities, collaborating where appropriate, with others within Ethics & Compliance.
  • Lead the compliance integration activities of new Astellas acquisitions to assimilate business practices and establish a culture of compliance
  • Conduct reviews and approvals of requests for meetings with HCPs and payments to HCPs and HCOs to ensure compliance, alignment and consistency with internal and external guidelines, policies and procedures.
  • Proactively identify client's compliance training and education needs, and participate in the development, implementation and delivery of innovative compliance training materials, communications, presentations, workshops and systems.
  • Conduct monitoring of Company events, programs and activities, such as interactions and meetings with HCPs, advisory boards, consultant meetings, symposium, Congresses, investigator meetings, and implement appropriate corrective action, where necessary.
  • Partner with Ethics & Compliance and Legal colleagues across regions to address issues and identify opportunities for collaboration, alignment, process improvement and best practice sharing.
  • Conduct needs assessments to identify compliance support needs and opportunities on a continuing basis, assist in identifying potential risk areas and assists in the development, execution and implementation of strategic and tactical plans to address identified risks and needs.
  • Contribute to the development and implementation of long-range strategic plans and initiatives to enhance compliance policies, processes and controls regionally and globally.
  • Collaborate with client management, Human Resources and Legal on compliance matters and investigations as appropriate to address specific compliance issues.
  • Other duties as assigned.

Quantitative Dimensions:

  • Establish a strong and visible compliance presence with the client's organizations.
  • Review materials and documentation related to engagements and meetings with HCPs and funding provided to HCOs
  • Conduct compliance training sessions for client groups/year
  • Conduct ongoing monitoring of documentation related to client activities, events and programs
  • Monitor live activities, events and programs/year

Organizational Context:

This position typically interacts with client employees through the President level globally, , as well as those within other functions, such as Finance, Legal, Government Affairs and Human Resources.

Qualifications:

Required

  • BA/BS degree
  • 10+ years of related work experience
  • 5+ relevant pharmaceutical industry experience working within and/or directly supporting an R&D and Medical Affairs organization
  • Significant knowledge of and experience in industry compliance issues impacting R&D and Medical Affairs, both within the US and globally
  • Demonstrated team leadership skills and strategic focus required. 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 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 with little or no supervision, and manage multiple projects simultaneously.
  • Strong work ethic and ability to produce high quality work under deadline pressures.
  • Ability to travel within the US and internationally up to 25%

Preferred

  • Prior pharmaceutical compliance experience is preferred
  • Masters or other advanced degree preferred

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Ethics and Compliance

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