Shire US Compliance Specialist in Lexington, Massachusetts

Primary Role:

The Compliance Specialist reports to the Sr. Business Partner, US Compliance, and provides primary support to 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. Responsibilities include membership on the US Compliance Team, the implementation of policies, process review/monitoring and improvement, the development and delivery of targeted training, and 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.

Responsibilities:

  • 60% Implementation of policies, process review and improvement; collaborate with US compliance personnel, the Legal department and other support functions

  • 25% Develop targeted training for Shire businesses and support the development of policies, process and procedures in key compliance risks areas

  • 15% Support the US Compliance function with projects and initiatives that contribute to the development, implementation and management of the company’s compliance program

Key Skills, Abilities & Competencies:

Strong interpersonal skills and ability to lead change through influence. Ability to interact with and counsel business leads. Ability to accommodate and manage ambiguity. Ability to execute 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 & Experience Requirements:

  • Bachelor's degree from an accredited institution

  • Minimum of 5 years of related work experience with particular focus in the pharmaceutical industry or implementation of compliance programs

  • Understanding of U.S. pharmaceutical/biotech and other regulations, sales, marketing and medical practices

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

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.

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.