Type of Company: Pharmaceutical Manufacturer, $1-2 billion in annual revenue
Reports to Head of Monitoring - International
Job Summary: This individual is primarily responsible for the execution and continuous improvement of the Compliance Monitoring Program. This individual will collaborate with line management and Global Compliance and Risk Management (GCRM) colleagues to design, update and execute monitoring plans for the regional and country organizations. This individual will develop monitoring plans, oversee the completion of monitoring activities by the local management (including the potential coordination of external vendors retained to complete field-based monitoring activities) as well and analyze the results of reports and other data-based monitoring activities. The Associate Director may also personally conduct field and home office monitoring activities and work with business functions and other colleagues from GCRM to collaborate on how to address compliance findings. Monitoring activities will focus on ensuring activities executed are consistent with laws, regulations, industry codes (e.g., EFPIA), and internal policies. Areas of focus include monitoring adherence to policies in areas such as interactions and payments to HCPs, promotion, medical affairs activities, travel and entertainment and clinical development activities (except those related specifically to conducting clinical trials).
40%: Responsible for creating project plans and leading compliance monitoring activities to ensure policies and procedures contain appropriate controls to facilitate ongoing monitoring. Plans to include:
• Key risks
• Mitigating Strategies
• Monitoring/Audit approach to check for adherence
• Key Performance Indicators (KPIs)
Establish detailed approach for implementing the monitoring plan, which may include coordination and planning with line management, Data Analytics, IT, Audit and External Vendors.
20%: Oversight of monitoring activities conducted by external vendors retained to assist in the completion of monitoring activities. In instances that the business function is conducting the monitoring with Global Compliance`s direction, ensure that the monitoring is being conducted as described in the Annual Compliance Monitoring Plan and that findings are being addressed.
20%: Assist in the creation of monitoring reports for management and the development of oversight tools. Develop system/tools to track remediation of outliers identified through various monitoring activities. Oversee accuracy of monitoring reports and collect ongoing feedback from management regarding usefulness of monitoring tools. Provide training on use of reports and tools, as assigned by the Head of Monitoring.
May be asked to present findings from business-lead monitoring activities to the Chief Compliance Officer and/or the Compliance Committee.
20%: Personally conduct monitoring activities which may include field monitoring ride-alongs, monitoring of both live and remote speaker programs, monitoring of advisory boards, speaker training and other meetings. Conduct home-based monitoring of business processes. Analyze monitoring reports from data-based monitoring activities and make recommendations to the Head of Monitoring on potential enhancements to the Monitoring Plan.
30-35% Travel Required
Bachelor's Degree Required, MBA, JD or Advanced degree desirable
Minimum 8-10 years of related work experience
Greater than 7 years pharmaceutical industry experience required
Minimum of 4-6 years of compliance or internal audit is required
Prior experience in compliance monitoring program highly desirable
Prefer candidate with prior pharmaceutical sales or marketing experience, who understands commercial and/or clinical practices
Experience interfacing with IT and developing IT solutions desirable
Direct or indirect experience with compliance audit, a plus
Working knowledge of laws, regulations, and industry codes (e.g., PhRMA, EFPIA, IFPMA) affecting the pharmaceutical industry is required
Excellent communication skills (verbal and written)
Excellent Project Management skills
Strong Analytical skills
Strong Presentation skills
Ability to partner and collaborate effectively with all levels of the organization
Comfort in raising issues and having difficult conversations
Good coaching skills
Understanding of IT systems and monitoring tools (knowledge of SAP, IDEA data analysis software, Automated Control Language (ACL) is a plus)
Strong organizational skills with attention to detail
Ability to problem solve in a manner that demonstrates both strategic and tactical thinking
Ability to work with confidential materials and maintain confidentiality of the assignment
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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