The Compliance Business Partner reports to the Head of Compliance, US, and provides primary direct support to certain Shire Business Units operating in the US. The role provides primary support to the Head of Compliance, US in leading the development, implementation and management of the company's compliance program in the US. With particular focus on the Shire commercial and medical affairs business in the US, responsibilities include membership on the BU Leadership Teams, the implementation of policies, process review/monitoring and improvement, the development and delivery of targeted training, and counseling of the business unit for the purpose of fostering compliance with applicable laws and regulations in a manner consistent with best practices. Responsibilities will also include coordination with other Global Compliance and Risk Management functions in connection with policy development, training, monitoring, and investigations, and coordination with and support of other company Compliance personnel.
60% Counsel and provide leadership to Shire business units on compliance issues; work with other compliance personnel in US and with the Legal department and other support functions on various initatives
25% Develop targeted training for the assigned Business Unit and support the development of policies, process and procedures in key compliance risks areas
15% Develop and execute risk assessments and reviews of compliance risk areas to determine need for improvement
Education & Experience Requirements
• Bachelor's degree from an accredited institution;
• Post-graduate degree, law degree or healthcare compliance certifications a plus, but not required.
• Minimum 10-14 years of related work experience with at least 7 years experience in the pharmaceutical industry or in the development and implementation of compliance programs.
• Understanding of U.S. pharmaceutical/biotech and other regulations, sales, marketing and medical practices. Similar experience with international regulations and practices would be a plus.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.