Assoc Dir, Compliance & Data Ops

Position Summary:

The Associate Director, Compliance and Data Operations, Rare Disease is responsible for managing and supporting key elements of the Company's compliance and data operations programs to ensure adherence by the Company's Rare Disease business unit to all applicable laws, regulations, and internal policies. This position plays a critical role in the design, implementation, and continuous improvement of compliance monitoring, data governance, reporting, and operational risk management across the organization.

The role serves as a bridge between Legal, Compliance, IT, and Finance functions to ensure proper data integrity, transparency, and audit readiness in a highly regulated pharmaceutical environment.

Essential Job Accountabilities:

Compliance Program Management

* Support the development, implementation, and execution of the Company's compliance and ethics programs in accordance with applicable federal and state laws, including FDA, DOJ, OIG, and SEC guidance.

* Monitor compliance with company policies, procedures, and Code of Conduct, ensuring effective internal controls are maintained.

* Collaborate with internal stakeholders to assess risk areas and implement mitigation strategies.

* Coordinate and maintain compliance documentation, certifications, and audit support materials.

Data Governance and Operations

* Lead or support initiatives related to compliance data management, reporting, and operational efficiency.

* Oversee collection, validation, and reporting of data used for compliance monitoring, including transparency reporting, financial disclosures, and third-party oversight.

* Ensure data integrity across systems supporting compliance functions (e.g., aggregate spend, investigations, monitoring, or due diligence platforms).

* Partner with IT and business teams to enhance data governance frameworks, ensuring data accuracy, accessibility, and regulatory compliance.

Monitoring, Auditing, and Reporting

* Develop and execute compliance monitoring activities, data analytics, and reporting processes to identify risks or irregularities.

* Support the preparation of periodic compliance reports for executive leadership and the Audit Committee.

* Track and analyze trends in compliance metrics to recommend improvements to systems and controls.

Regulatory and Transparency Reporting

* Support all transparency and disclosure reporting obligations, including federal (Open Payments/Sunshine Act) and applicable state requirements.

* Maintain documentation for all submissions and support timely and accurate reporting.

* Partner with Legal and Finance to ensure proper tracking and categorization of HCP/HCO spend data.

Training, Policies, and Awareness

* Assist with the development and delivery of compliance training and communication initiatives.

* Support drafting, updating, and implementation of compliance-related policies and standard operating procedures (SOPs).

* Reinforce a culture of ethics and accountability through consistent communication and engagement with business partners.

Cross-Functional Collaboration

* Collaborate closely with Legal, Finance, IT, Commercial, and HR to ensure data and compliance processes are integrated, consistent, and audit-ready.

* Provide compliance support for new initiatives, system implementations, and corporate projects.

* Serve as a subject matter resource for data-driven compliance operations.

Qualifications and Requirements

Education:

* Bachelor's degree required in Business, Legal Studies, Accounting, or related field.

Experience:

* Minimum 8 years of experience in Compliance, Legal Operations, Internal Audit, or related field within a pharmaceutical, biotechnology, or life sciences company.

* Strong understanding of pharmaceutical industry compliance obligations, including HCP transparency reporting, FCPA/anti-bribery, and data privacy (GDPR/CCPA) requirements.

* Experience working with compliance management systems, data analytics tools, and ERP or reporting systems (e.g., Oracle, SAP, Concur, Med Pro, or similar).

* Familiarity with SOX compliance, government pricing data interfaces, and SEC reporting processes preferred.

Skills and

Competencies:

* Excellent analytical and…