Shire Compliance Business Partner, US Neuroscience in Lexington, Massachusetts
The Compliance Business Partner reports to the Head, US Compliance Business Partners, and provides primary direct support to certain Shire businesses operating in the US. The role also supports the US Compliance function in leading the development, implementation and management of the company’s compliance program in the US. With particular focus on the Shire commercial business and medical affairs in the US, responsibilities include membership on the Business Leadership Teams, the implementation of policies, process review/monitoring and improvement, the development and delivery of targeted training, and counseling of the business 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.
Working as part of the senior level compliance team and in collaboration with other stakeholders (e.g. Legal Department), the candidate will have substantial authority to drive and implement programs throughout the US businesses, particularly in the US commercial business. The role will advise senior business leaders, including the business heads on key decisions. The role will represent the compliance function on cross functional efforts, while coordinating with Compliance leadership and Business Partner colleagues on key strategic decisions.
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 initiatives
25% Develop targeted training for the assigned business 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
KEY SKILLS AND COMPETENCIES:
Strong interpersonal skills and ability to lead change through influence. Ability to interact with and counsel senior business leaders. Ability to accommodate and manage ambiguity. Ability to execute both strategically and tactically. Excellent written and oral communication skills. Effective presentation skills and ability and willingness to adapt to new cultures. A flexible, collaborative and team-oriented approach to problem solving, and an ability to work in a fast-paced, rapidly changing environment. Proven ability to exercise strong business judgment with a strong understanding of the fundamentals of the pharmaceutical/biotech industry.
EDUCATION AND EXPERIENCE:
Bachelor's degree from an accredited institution;
Post-graduate degree, law degree or healthcare compliance certifications a plus, but not required.
Minimum of 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.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.