Associate Director, Compliance

Position Title: Associate Director, Compliance

Department: Legal                       

Reports To (title): Deputy Chief Compliance Officer

Location: King of Prussia, PA (hybrid work schedule)

Summary of Position:

This role will be responsible for assisting in Paratek’s healthcare compliance programs to ensure the company’s continued compliance with U.S. federal and state laws and regulations related to the promotion, sale and marketing of pharmaceutical products. Responsible for developing, implementing and oversight of healthcare compliance initiatives 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). 

Position Responsibilities: 

The roles and responsibilities will include the following:

• Help drive a culture of compliance throughout the organization and promote various compliance policies, procedures and initiatives.
• Continuously improve the healthcare compliance program, including, but not limited to, developing policies, conducting training, auditing, and monitoring, and conducting investigations.
• Conduct field ride-along and speaker program observations to monitor key compliance risk areas. Draft reports and identify/implement corrective actions.
• Assist in the completion of activities related to federal and relevant state transparency-driven compliance requirements.
• Review and critically analyze data to determine instances of suspected fraud, abuse, or non-compliance.
• Provide advice and support to Commercial, Medical, Clinical Operations, and other key business stakeholders related to healthcare compliance.
• Develop and implement tools which empower business stakeholders to make ethical and compliant decisions.
• Assist in managing compliance with training requirements and conducting required training classes.
• Maintain current understanding of laws, regulations, and industry codes applicable to pharmaceutical/biotechnology business activities and Compliance, along with recent trends and changes, and help provide related internal education and training.
• Additional responsibilities as assigned.

Candidate Requirements: 

• Emulates Paratek’s core values – Resourceful, Passionate, Purposeful and Collaborative

Skills and Competencies:

• Excellent interpersonal skills
• Unquestionable ethics and integrity
• Sound judgment, with an understanding of the intersection of legal, regulatory and business issues
• 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 and detail oriented with demonstrated ability to manage time, handle a variety of tasks and responsibilities, and meet timelines without supervision
• Possess credibility and gravitas to be viewed as a trusted advisor

Minimum related experience required to perform job:

• At least five years of experience in the pharmaceutical industry with specific healthcare compliance-related experience.
• Well-rounded, experienced compliance expert who has played a key role as an engaged leader on matters relating to the marketing and promotion of pharmaceutical products and possesses an impressive track record of providing not only sound compliance advice, but also excellent business judgment concerning overall healthcare compliance and risk management

Education:

• Undergraduate degree required 

Additional Information:

• In-Office requirements: 2-3 days per week
• Travel requirements (%): 10%