Assistant Director Compliance Cover Letter

I submit this application to express my sincere interest in the assistant director compliance position.

In my previous role, I was responsible for nCAA & conference rules education and interpretation programs for administrators, coaches, support staff, student-athletes, booster groups, campus partners/constituents that promotes culture of compliance and institutional control.

Please consider my experience and qualifications for this position:

• Significant knowledge of and experience in industry compliance issues impacting R&D and Medical Affairs, both within the US and globally
• BA/BS with an emphasis in business, economics, finance, accounting or equivalent, or substantial securities related education, compliance experience and/or auditing (internal/external) experience
• Experience with or working knowledge of of the NCAA databases and online programs such as Compliance Assistant (CAi), Legislative Services Database (LSDBi) or Eligibility Center for initial eligibility and amateurism rules
• Knowledge of NCAA guidelines
• Knowledge of managing compliance issues in a work setting
• Working knowledge of NCAA rules and familiarity with the NCAA’s Compliance Assistant, Legislative Services Database applications and ARMS Software
• Experience with Microsoft Excel, Word, and other related software that allows for the efficient and effective preparation of reports preferred
• Implement quality assurance processes for U.S. Pharmacovigilance (USPV) services and products

I submit this application to express my sincere interest in the assistant director compliance position.

In the previous role, I was responsible for planning, logistical and staffing support to the Compliance and Enterprise Risk Committee, including coordination with operating company compliance committees and programs.

My experience is an excellent fit for the list of requirements in this job:

• Collaborate with Global Pharmacovigilance (GPV) and Global Development (GD) Global Quality department in preparation of regulatory inspections
• Analyze audit and inspection findings related to USPV and GPV and suggest remediation actions
• Maintain USPV Quality Document system
• Support the development of selected SOPs/Operations Management (OM) referring to USPV processes and adjustment of these SOPs where necessary
• Ensure adequate input from USPV and GPV business functions
• Demonstrated experience working in a cross-functional role in a quality and compliance setting
• Experience in SOP management, medical writing and Good Documentation Practices
• Accomplished and expert knowledge in MedDRA coding using terminology prescribed by global regulatory authorities

Please consider me for the assistant director compliance opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for oversight of all student financial aid operations, including, but not limited to: funds management, NCAA and Big10 athletic compliance, policy analysis/planning, risk management and university compliance, scholarship administration and processing operations.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Contribute to the definition of relevant quality measures including quality targets for USPV services and products including single case handling, aggregate reports, and signal detection and management
• Develop and implement partner PV management and oversight processes
• Support the assessment/quality check of U.S. contracts/agreements for PV relevance and accuracy
• Maintain internal/external master list for oversight of all partners/programs impacting USPV
• Perform quality assurance processes for USPV services and products
• Perform quality assurance for selected USPV services and products
• Define, implement and maintain consistent metrics and Key Performance Indicators (KPIs) including those for U.S. partners and areas relevant to PV (e.g., plausibility checks, Clinical Research Organizations (CROs), U.S. contracts/agreements)
• Develop, implement and maintain an internal audit program focused on ensuring compliance with contract approval Standard Operating Procedures (SOPs)

I am excited to be applying for the position of assistant director compliance. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for assistance in the daily operation of NAIA rules compliance program inclusive of, but not limited to: academics, financial aid, Title IX compliance; camps/clinics, rules education and monitoring, and recruiting activities; coordinate all Student-Athlete Affairs programming; coordinate and log all department outreach activities; assist with game day operations; coordinate select athletic banquets.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Provide detailed analysis of late single cases
• Request investigation and provision of both root cause and corrective action for non-compliance from USPV external partners
• Analyze data to derive project proposals for improvements of USPV business processes
• Ensure and perform corrective actions and/or preventive actions (CAPA) management for identified quality issues relevant to USPV and U.S. colleagues and partners
• Request and monitor CAPAs for selected USPV services and products
• Track/Monitor implementation of corrective/preventive action related to findings from compliance monitoring, quality assurance, audits and inspections, USPV Business Reviews, and U.S. partner plausibility checks and compliance assessments
• Provide statistics and trend analysis for USPV CAPAs
• Contribute to the overall inspection readiness of USPV through proactive creation of inspection relevant materials

Please consider me for the assistant director compliance opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for technical expertise to university staff members, coaches, student-athletes, parents of student-athletes, and representatives of athletics interests regarding athletic compliance issues.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Certification in quality and compliance (e.g., Certified Manager of Quality/Organizational Excellence)
• Experience working in an Intercollegiate Athletic Compliance Office
• Implement quality assurance processes for Pharmacovigilance (PV) services and products
• Contribute to the definition of relevant quality measures including quality targets for PV services and products including single case handling, aggregate reports, and signal detection and management
• Define, implement and maintain consistent metrics and Key Performance Indicators (KPIs) in close cooperation with PV functions
• Perform corrective actions and/or preventive actions (CAPA) management for identified quality issues within PV
• Collaborate with Global Development (GD) Global Quality department in preparation of regulatory inspections
• Maintain the PV Quality Document system