Job Details

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

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 Compliance Program, and related projects.
• Enhance, develop, and maintain monitoring and auditing plans, playbooks, templates, trackers, reporting cadence, and reporting documents.
• Lead day-to-day operations and execution of compliance monitoring and auditing activities for company healthcare Compliance Program to support the Company’s strategic plans and tactics.

Live Monitoring:

• Oversee and coordinate with live monitoring vendors and other colleagues to meet annual live monitoring plan goals.
• Conduct live monitoring of external-facing activities – including HCP interactions, speaker and other 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 vendor to ensure timely data exchanges and refreshes and the accuracy of data and mapping files.
• Coordinate with other teams to collect and manage data and to identify new data sources.

Collaboration and Enhancements:

• Collaborate with other operations teams – including Commercial Operations and Medical Operations – our Digital Innovation team, and those teams’ 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/or 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, Corrective Action:

• Follow up with field leaders and field colleagues on potential findings, feedback, and to track assigned corrective action, when applicable.
• 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.

Drive Compliance Program,  processes, and systems enhancements:

Policy, SOP, Communications, and Training:

• Draft, or enhance existing, policies, training, and other resources that translate policies and procedures into practical and easy to understand guidance for employees.
• Manage the related policy plans, stakeholder reviews, and approval documentation.

Compliance Program Operations and AI

• Advise and support the 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 that improve Compliance Operations as well as policy resources and tools for the activities and teams Legal-Compliance supports.

Knowledge:

• 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) –  in order to identify opportunities to enhance company policies, procedures, and monitoring/auditing efforts.

Education/Experience 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.

Additional Skills/Experience/Requirements:

• The ideal candidate will embody 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 and experience with data analytics tools 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 an 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%.