Responsibilities include:
• Manage and execute field-based monitoring activities (e.g. routine sales call and promotional speaker program assessments) and records monitoring activities (e.g. field coaching reports, electronic medical information requests, travel & entertainment expenses, email, etc.) related to the interactions Sales and Marketing, Medical Affairs and Commercial Operations employees have with Health Care Professionals.
• Develop approaches to monitoring using data from various financial and business systems (e.g. SAP, local financial systems, CRM, etc.) and using data mining techniques.
• Develops, maintains and reviews Compliance reports proactively providing insight, analysis and reporting with respect to issues or trends resulting from Compliance monitoring activities including where further investigation or training opportunities may be needed.
• Assists with the performance of corporate investigations adhering to the company’s standard methodology.
• Liaise with other corporate functions such as Human Resources, Legal, Internal Audit, and Corporate Security in the performance of these duties including ensuring that Corporate Compliance has a line of sight into all U.S. investigations.
• Provide guidance to these other corporate functions including ensuring they adhere to our standard investigations methodology.
• Bring to bear independent judgment in the conduct of investigations and interactions with senior management, vendors and other internal and external stakeholders.
• Independently execute or manage international compliance monitoring assessments at Shire LOCs or distribution partners. These assignments could be performed on site by this position, or by third party vendors or the financial controllers’ network.
• Develops and assists with the delivery of reports to senior LOC management.
Education and Experience Requirements
• Bachelor’s degree (or equivalent) from an accredited institution; post-graduate degree or law degree may be a plus.
• At least 5 years of experience with some experience in the pharmaceutical industry with some of that experience involving the implementation and/or execution of compliance programs and/or the performance of commercial compliance reviews or audits as part of an internal audit function.
• Experience managing 3rd party vendors.
• Must demonstrate knowledge and understanding of pharmaceutical regulations and compliance issues, sales and marketing practices, etc.
• Must have strong interpersonal skills, a flexible, collaborative and team-oriented approach to problem-solving and an ability to work in a fast-paced, rapidly changing environment.
• Experience in delivering clear and concise written and oral presentations.
• Experience managing projects.
Key Skills, Abilities, and Competencies
• Ability to execute both strategically and tactically.
• Strong project management skills.
• Strong analytical skills including the ability to provide creative solutions to problems encountered. .
• Ability to function in a global environment with a wide range of stakeholders understanding cultural differences.
• Ability to operate independently and build strong networks throughout the organization.
• Ability to exercise business judgment with a strong understanding of the fundamentals of the pharmaceutical industry.
• Ability to manipulate and analyze data using from various systems using various software tools for purposes of identifying potential areas of compliance monitoring.
• Investigation and analytical skills including the ability to consistently demonstrate a fair and balanced mindset.
• Flexible, collaborative and team-oriented approach to problem-solving and an ability to work in a fast-paced, rapidly changing environment.
• Ability to analyze complex business processes and make constructive control enhancement recommendations.
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