Astellas Pharma Associate Director CIA Operations 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 Associate Director CIA Operations opportunity in Northbrook, IL.
Purpose & Scope:
The Associate Director is responsible for the implementation and administration of a work plan and associated milestones for key E&C projects and Corporate Integrity Agreement (CIA) requirements. In addition, this role requires the comfort and experience of communicating with senior management and executives within the organization. This role requires familiarity with compliance operations, including development and implementation of policies, procedures, operational systems and monitoring platforms. This role encompasses the implementation of strategies, and the development and implementation of tools and resources to support a culture of high performance, and continual operational improvement.
Essential Job Responsibilities:
- Work closely with external and internal business, legal and compliance stakeholders.
- Help manage and correct potential risk areas, taking into account OIG guidance, industry trends, and past and planned business activities.
- Responsible to manage large scale ongoing projects. Working collaboratively with team members and consultants to ensure that all project requirements, deadlines, and schedules are on track. Responsibilities include drafting project deliverables, status reports, and establishing effective project communication plans as well as the proper execution of said plans.
- Knowledge in compliance with law, regulations and industry codes relevant to a highly regulated industry. Knowledge of best practices relating to compliance in highly regulated industries.
- Manage corrective action plans to ensure that corrective action is appropriately documented, implemented and addressed.
- Track observations across activities to identify compliance opportunities, including implementing additional controls, policies, processes, training or communication. Work with the business and others within the Compliance Department, as appropriate, to communicate and address observations and recommendations.
- Build networks and relationships within the Compliance department and work collaboratively across other functional areas to build support for work plans and initiatives.
- Stay current on compliance trends by researching industry publications and literature, benchmarking and consulting with industry counterparts and attending industry conferences and continuing education programs.
- Other Ethics & Compliance initiatives deemed necessary to further enhance Astellas' commitment to ethics & compliance.
- This position will manage concurrent initiatives across a variety of Astellas-sponsored commercial and non-commercial activities, and develop and maintain collaborative relationships with internal stakeholders across multiple Astellas business units to identify and mitigate potential risk to the Company.
Position reports to the Director, and typically interacts with employees across various Astellas functions, including without limitation, the Astellas Commercial, Medical Affairs and Research and Development organizations. Also collaborates with Legal and outside consultants.
- BS /BA degree from an accredited college or university.
- 7+ years of relevant management, monitoring, auditing, investigations or consulting experience
- Relevant pharmaceutical industry experience.
- Excellent written and verbal communication skills.
- 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 prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data.
- Demonstrated ability to handle confidential information with discretion and effectively collaborate with multiple functional units.
- Demonstrated initiative and problem-solving skills, including the ability to proactively identify issues, anticipate needs and develop practical, meaningful solutions.
- Ability to interact with colleagues with the appropriate respect and sensitivity.
- Possesses a strong orientation to detail and the ability to work in a fast-paced environment.
- 5 years of project management experience
- Expertise within the life science industry
- Compliance program experience
- CIA or Internal Review Organization (IRO) experience
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Ethics and Compliance