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Shire Integrity Assurance Business Partner - Lexington, MA in Lexington, Massachusetts
The purpose of this role is to manage operations for Integrity Assurance activities within U.S. Marketing Operations, focusing on ensuring high quality operations and delivery to the Franchises. This role will have in-depth interaction with the U.S. Integrity Assurance Operations Coordinator.
Key responsibilities include:
Ensure CIA (Commercial Integrity Agreement) readiness via active project management in the areas of U.S. Marketing Operations
Ensure operational processes meet CIA, Compliance, Privacy and State & Federal regulations
Act as key interface to U.S. Marketing Operations team on compliance requirements, questions and concerns
Develop policies and procedures for the Marketing Operations groups that ensure compliance service delivery to the U.S. Franchises
Develop standard operating procedures (SOPs) in partnership with Marketing Operations
Enact mechanisms to audit and monitor key processes to ensure SOP requirements are met
Partner with Integrity Assurance Lead, Sales Operations and Learning & Development to pull-through training on key business processes ensuring in-depth understanding of compliance requirements
Partner with Integrity Assurance and other team members to document process redesign efforts in Marketing Operations
Proactively audit, assess and develop corrective plans to address Integrity Assurance issues in area of scope
Up to 10% of travel. May vary based on Shire work location and prioritized projects.
Education and Experience Requirements
BA/BS degree in business, life sciences or related discipline
5+ years of experience in the biotech/pharmaceutical sector
In-depth experience in Marketing Operations structure and processes
Extensive understanding of Industry Compliance regulations and State and Federal Laws governing the biotech/pharmaceutical industry
Experience in Project Management, Lean Six Sigma or other equivalent process improvement methodologies beneficial
Key Skills, Abilities, and Competencies
Demonstrated understanding and experience with executing implementation of standardized solutions for ensuring compliance to CIA, Compliance, Privacy and State & Federal regulations
Experience in documenting processes and leveraging systems to support compliance solution delivery
Exceptional project management skills with an evident ability to multi-task and prioritize and with attention to detail and strong organizational skills
Ability to take “big picture” view whilst executing tactical deliverables
Generates innovative solutions, and enables others to do the same
Draws on unexpected or seemingly unrelated ways of thinking
Domain knowledge of supported Therapeutic Areas
Knowledge of Marketing Operations structures and processes
Experience in dealing with complexity including interrelated, interdependent Marketing Operations processes and systems
Strong consultative, listening, problem definition skills
Encourages accountability and responsibility that enables others to act with integrity
Ability to clearly communicate the need for change and to actively respond to possible resistance
Demonstrates critical, creative thinking and problem-solving skills, and the ability to produce clear and concise written and verbal communications
Customer service mentality and ability to build and maintain strong relationships
Ability to work well with individuals in all levels of the organization as well as with external vendors and consultants
Comfort with ambiguity with ability to manage without formal authority
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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, gender identity, 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.
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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
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.