Associate Director, Legal-Compliance

About the role

Support operational planning and project management to continuously align the company’s healthcare Compliance Program with strategic plans and tactics.

Responsibilities

• Planning and Project Management:
  • Co-lead annual and periodic assessments of the Seven Elements Compliance Program, identifying emerging risks and recommending strategic priorities for the Compliance Program roadmap.
  • Develop and maintain project plans to support the Compliance Program and related projects.
  • Enhance, develop, and maintain monitoring and auditing plans, playbooks, templates, trackers, reporting cadence, and reporting documents.
• Live Monitoring:
  • Oversee and coordinate with live monitoring vendors and colleagues to meet annual live monitoring plan goals.
  • Conduct live monitoring of external-facing activities, including HCP interactions, speaker and educational programs, advisory boards, field activities, and patient-facing activities.
• Data Analytics Audits:
  • Use data analytics dashboards and operational reports to identify trends, outliers, potential policy deviations, repeat issues, and emerging risk areas across field teams and business functions.
  • Oversee and coordinate with data analytics vendors to ensure timely data exchanges, refreshes, and accuracy of data and mapping files.
  • Coordinate with other teams to collect and manage data and identify new data sources.
• Collaboration and Enhancements:
  • Collaborate with operations teams (Commercial Operations, Medical Operations, Digital Innovation) and their vendors to identify additional data, analytics, and process synergies.
  • Identify opportunities to enhance data analytics dashboards, processes, and reporting based on industry enforcement/guidance and identified needs.
• Other Audits:
  • Based on routine compliance assessments, identify and conduct data-driven audits across relevant systems and data sources, including customer relationship management systems, expense data, transparency/transfer-of-value data, and other documentation repositories.
• Reporting:
  • Prepare clear, accurate, and high-quality Compliance monitoring and auditing reports for presentation to the Compliance Committee and other senior leaders.
• Follow Up and Corrective Action:
  • Follow up with field leaders and colleagues on potential findings, feedback, and track assigned corrective action.
  • Translate monitoring and audit insights into recommended updates to policies, SOPs, field guides, training, communications, controls, and business processes.
• Vendor Oversight:
  • Manage or coordinate vendors supporting monitoring, auditing, analytics, and field monitoring activities, including oversight of quality, timelines, budget tracking, and deliverables.
• Compliance Program, Processes, and Systems Enhancements:
  • Policy, SOP, Communications, and Training: Draft or enhance policies, training, and resources to translate policies and procedures into practical guidance for employees. Manage related policy plans, stakeholder reviews, and approval documentation.
  • Compliance Program Operations and AI: Advise and support continuous improvement of Compliance Operations processes and systems, including enhancing documentation, tracking tools, reporting templates, and opportunities to automate or streamline manual processes. Use AI-enabled and analytics tools appropriately to support drafting, summarization, trend identification, and reporting while validating outputs and following company policies. Develop AI tools to improve Compliance Operations and policy resources.
• Knowledge:
  • Keep current on applicable laws, regulations, codes, guidance, and industry best practices relevant to pharmaceutical and biotechnology compliance (e.g., OIG guidance, PhRMA Code, Anti-Kickback Statute, False Claims Act, FDA regulations, HCP spend transparency like the Sunshine Act) to identify opportunities to enhance company policies, procedures, and monitoring/auditing efforts.

Requirements

• Bachelor’s degree required; advanced degree such as JD, MBA, MPH, or other relevant graduate degree preferred.
• Compliance or auditing certification preferred.
• 8+ years of relevant experience in compliance operations, internal audit, monitoring, or a related function, including 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.

Skills

• Embodies company core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• 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 preferred; experience with data analytics tools (e.g., Tableau, Power BI) a plus.
• 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.
• Excellent written communication skills, with the ability to draft clear audit reports, monitoring summaries, executive-ready updates, corrective action summaries, and practical business guidance.
• Strong verbal communication and interpersonal skills, including the ability to discuss potential findings, ask effective follow-up questions, and maintain trust with business partners.
• High attention to detail, analytical and issue-spotting skills, strong judgment, and the ability to distinguish technical documentation issues from higher-risk compliance concerns.
• Strong project management skills, including the ability to develop and manage project plans, coordinate cross-functional workstreams, follow up on action items, and track deliverables.
• Strong time management skills, including the ability to manage multiple projects, prioritize, meet deadlines, and follow up through closure.
• Practical, solutions-oriented approach with the ability to work independently while escalating appropriately.
• Excellent collaboration skills in a cross-functional environment, including Legal-Compliance, Commercial, Medical Affairs, Patient Advocacy, Finance, IT, and external vendors.
• Strong drafting and editing skills in Word, PowerPoint, Excel, and similar programs.
• 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.
• Ability to travel domestically approximately 30%.

Pay

Compensation based on level and experience, with a range between $173,000 and $225,000.