Associate Director, Compliance Operations

Paratek PharmaceuticalsKing of Prussia, PA
Hybrid

About The Position

The Associate Director, Compliance Operations will play a critical role in advancing the organization’s compliance program through operational excellence, data-driven insights, and cross-functional collaboration. This individual will lead auditing and monitoring activities, oversee compliance reporting and dashboards, conduct investigations, and partner cross-functionally to communicate compliance insights and results. This individual contributor role will be responsible for executing day-to-day operational activities in a growing organization while offering regular interaction with senior leadership and visibility to executive leaders through presentations and cross-functional meetings. This individual should be self-motivated and able to work with minimal supervision, have strong operational and analytical skills, attention to detail, and the ability to work collaboratively across functions in a regulated pharmaceutical environment to ensure alignment with business goals and objectives, and adherence to applicable state and federal aggregate spend and compliance laws, regulations, and codes (such as the Anti-Kickback Statute, False Claims Act, OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code & FDCA).

Requirements

  • Emulates Paratek’s core values – Passionate, Resourceful, Collaborative, Purposeful
  • Bachelor’s degree required
  • At least eight years of experience in the pharmaceutical industry with specific healthcare compliance-related experience, with a strong focus on operations, auditing, and monitoring.
  • Excellent interpersonal skills
  • Unquestionable ethics and integrity
  • Sound judgment, with an understanding of the intersection of legal, compliance, regulatory and business issues
  • Experience analyzing data, creating and working with dashboards, and translating data analysis into insights and trends
  • Strong intellect and solid business acumen, coupled with pragmatic and problem-solving skills
  • Innovative, strategic and pro-active in anticipation of the future needs of the Company
  • Proven “hands-on” approach with solid relationship-building and listening skills
  • Ability to understand, simplify and clearly articulate complex issues
  • Well organized, reliable, and detail oriented with demonstrated ability to manage time, handle a variety of tasks and responsibilities, and meet timelines with minimal supervision
  • A well-rounded, collaborative and team-oriented compliance professional who is proactive, self-motivated to drive and execute compliance initiatives and can manage multiple tasks in a fast-paced environment while understanding overall healthcare compliance and risk management.

Responsibilities

  • Lead the execution of compliance auditing and monitoring activities in alignment with regulatory requirements and internal policies.
  • Maintain and improve processes to drive operational efficiency and consistency across compliance activities.
  • Understand compliance risks and identify potential trends through monitoring activities, escalating findings as appropriate.
  • Own, develop and maintain compliance dashboards and routine reporting, working directly with leadership on results.
  • Compile and analyze compliance data to support ongoing monitoring and reporting needs.
  • Prepare and deliver presentations summarizing compliance activities, findings, and trends.
  • Conduct internal compliance investigations related to potential violations of company policies or regulatory requirements.
  • Ensure timely documentation, resolution, and remediation of identified issues.
  • Partner with Legal, Human Resources (HR), and business stakeholders on investigation outcomes and corrective actions.
  • Lead compliance processes related to Open Payments (Sunshine Act) reporting, including vendor management and data validation.
  • Own tracking and maintaining state licensing requirements and related documentation.
  • Collaborate with third-party vendors to ensure accurate data collection, reporting, and adherence to contractual obligations.
  • Partner with Compliance leadership and cross-functional teams to support compliance initiatives and reporting needs.
  • Prepare presentations and materials for internal stakeholders.
  • Serve as a point of contact for routine compliance operations questions and requests.
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