Assoc Dir, Compliance & Data Ops

ANI Pharmaceuticals, Inc.; Princeton (NJ); On-site; USD 155,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plans

Paid time off

Job summary

A pharmaceutical company located in Princeton, NJ is seeking an Associate Director of Compliance and Data Operations. This role manages compliance programs ensuring adherence to regulations while improving data governance across the Rare Disease unit. Candidates should possess at least 8 years of experience in compliance or legal operations, strong analytical and project management skills, and a Bachelor's degree in a relevant field. The company offers a competitive salary and comprehensive benefits package.

Qualifications

• Minimum 8 years of experience in Compliance, Legal Operations, or Internal Audit.
• Strong understanding of pharmaceutical industry compliance obligations.
• Exceptional communication and interpersonal skills.

Responsibilities

• Manage compliance and data operations programs for the Rare Disease unit.
• Support development and execution of compliance and ethics programs.
• Collaborate with Legal, Compliance, IT, and Finance functions.

Skills

Analytical skills

Project management

Interpersonal skills

Data visualization

Compliance knowledge

Education

Bachelor's degree in Business, Legal Studies, or Accounting

Tools

Oracle

SAP

Concur

Power BI

Job description

JOB DESCRIPTION

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.

Position Summary

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.

Education and Qualifications

• Bachelor’s degree required in Business, Legal Studies, Accounting, or a related field.
• 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 with compliance management systems, data analytics tools, and ERP or reporting systems (e.g., Oracle, SAP, Concur, MedPro, or similar).
• Familiarity with SOX compliance, government pricing data interfaces, and SEC reporting processes preferred.
• Excellent analytical and problem‑solving skills with strong attention to detail.
• Strong project management and organizational abilities, capable of managing multiple priorities.
• Proficiency in Microsoft Excel, Power BI, or other data visualization tools.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively across departments.
• High integrity, professional judgment, and commitment to confidentiality.
• Proven ability to work in a fast‑paced, regulated, and dynamic environment.

Compensation and Benefits

The base salary range for this position is $155,000 – $195,000; the exact salary depends on various factors such as experience, skills, education, location, competencies, and industry‑specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short‑term and long‑term incentive program based on performance and company results.

ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays, and paid time off. Many of these benefits are subsidized or fully paid for by the company.