Compliance Specialist II presso Auburn Pharmaceutical Company

Description

The compliance specialist is responsible for monitoring and ensuring adherence to federal, state, and industry regulations in pharmaceutical distribution. This role involves reviewing new account applications, conducting licensing due diligence, monitoring orders for unusual activity, and reviewing data to detect compliance risks. In addition, will collaborate with internal team to promote a culture of compliance and operational integrity. 

Essential Functions 

•  Review new customer account applications to ensure completeness, accuracy, and proper licensing.
•  Perform due diligence on new accounts by verifying documentation, licensing status, and regulatory requirements.
•  Review and monitor orders to identify, investigate, and document unusual or suspicious activity.
• Analyze customer purchasing patterns using excel functions (pivot tables, formulas, dashboards) to detect irregularities or potential diversion.
• Conduct periodic audits of customer accounts, licensing, and order histories to ensure ongoing compliance.
• Prepare compliance reports, dashboards, and summaries for management review.
• Monitor regulatory requirements (FDA, DEA, state boards of pharmacy) and ensure company practices remain compliant. 
• Collaborate with sales, operations, and customer service teams to address compliance-related issues and ensure proper account on boarding.
• Assist in preparing responses to regulatory inquiries, inspections, and audits.
• Recommend process improvements to strengthen internal controls and reduce compliance risk.
•  Perform other duties as assigned.

Requirements

Position Qualifications 

• Dependability and willingness to accommodate work schedule.  

• Ability to fulfill internal customers’ needs while following company policies and procedures.

• Strong verbal and written communication skills; ability to speak clearly and effectively convey complex or technical information        at the executive level.  

• Demonstrate a self-confident approach to complete work assignment or defend a position or idea.  

• Ability to use appropriate interpersonal styles and communication methods to gain acceptance of a product, service, or idea.  

• Portray flexible and multi-tasking abilities.

• Strong time management, organizational, and prioritization skills.

• Clarity of communication is needed to determine the effectiveness of the performance in the entire sales operation department.

• Actively listen, attend to, convey, and understand the comments and questions of others.  

• Accept responsibility and account for his/her actions.  

• Ability to resolve antagonistic conflicts with others in a professional manner.

• Goal oriented with the desire to perform to the best of his/her ability. 

• Adept problem solver and show the ability to think quickly.  

Skills and Abilities 

Education:  Bachelor’s degree (four-year college or technical school) in business, healthcare administration, criminal justice, or a related field a plus; or work equivalent.

Experience: 2-4 years of experience in compliance, regulatory affairs, auditing, or pharmaceutical distribution preferred. 

Computer Skills:  Must be proficient in Microsoft suite of products including Word and Outlook. Proven proficiency in Microsoft Excel, including pivot tables, formulas, data analysis, and report/dashboard creation.

Other Skills

• Strong knowledge of state and federal regulations impacting pharmaceutical distribution; familiarity with Suspicious Order     Monitoring Systems (SOMs) a plus.

• Experience reviewing new accounts and conducting customer licensing due diligence required.

• Excellent analytical and investigation skills with a high attentional to detail.

• Strong verbal and written communication, including the ability to document findings and prepare clear reports. 

• Ability to manage multiple priorities and meet deadlines in a fast-paced regulatory environment. 

• Strong customer service skills