Associate Director, Legal-Compliance
$173,000–$225,000 year
On-siteSan Diego, California, United States
Job Summary
Conduct live monitoring of external-facing activities including HCP interactions, educational programs, and patient-facing events while overseeing vendor coordination and data analytics dashboards to identify trends and emerging risks. Execute data-driven audits across CRM, expense, and transparency systems, then prepare high-quality reports for the Compliance Committee and senior leaders. Draft policies, SOPs, and training materials to enhance the Seven Elements of the Compliance Program, utilizing AI tools to streamline documentation and process automation. Collaborate cross-functionally with Commercial, Medical, and Digital Innovation teams to align monitoring plans with strategic objectives and track corrective actions.
Required Qualifications
- Bachelor's degree
- 8+ years of relevant experience in compliance operations, internal audit, monitoring, or a related function
- 5+ years in life sciences healthcare compliance within or supporting a pharmaceutical or biotechnology manufacturer
- Experience developing and executing monitoring and auditing plans, including risk assessments, sampling, testing, workpapers, findings, remediation, and management reporting
- Strong working knowledge of the Seven Elements of an Effective Compliance Program and how monitoring, auditing, investigations, corrective action, policies, training, reporting, and culture operate together
- Experience with data analytics, dashboard review, metrics, trend analysis, and translating data into concise business-facing recommendations
- Ability to travel domestically approximately 30%
Desired Qualifications
- Advanced degree such as JD, MBA, MPH, or other relevant graduate degree
- Compliance or auditing certification
- Strong data analytics orientation, including the ability to work with large data sets, identify patterns, pressure-test assumptions, and convert findings into practical compliance recommendations
- Advanced Excel skills
- Experience with data analytics tools
- Strong understanding of responsible AI use for drafting, summarizing, analysis, and reporting; ability to verify AI outputs, protect confidential information, and use AI tools consistent with company policy
- Experience using analytics tools such as Tableau, Power BI, or similar tools
- Experience using AI assistants (e.g., ChatGPT), collaboration platforms (e.g., SharePoint), and other tools to seamlessly integrate technology into daily operations
- Experience using project management tools, such as Smartsheet, Microsoft Project/Planner, Excel-based trackers, or similar tools
- Experience using AI-enabled and analytics tools appropriately to support drafting, summarization, trend identification, and reporting, while validating outputs and following company policies
- Develop AI tools that improve Compliance Operations as well as policy resources and tools for the activities and teams Legal-Compliance supports
- Keep current on applicable laws, regulations, codes, guidance, and industry better practices, relevant to pharmaceutical and biotechnology compliance – including OIG guidance, PhRMA Code, Anti-Kickback Statute, False Claims Act, FDA regulations and guidance documents, and HCP spend transparency (e.g., Sunshine Act)
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