Compliance Specialist chez undefined

Summary Job Description:

The Compliance Specialist will support the department’s legal and compliance functions to help ensure the organizations’ alignment with all laws, regulations, licenses and accreditations applicable to the wholesale distribution of prescription drugs and devices. This position will support the maintenance of Direct Relief’s distributor licensing, creating and maintaining compliance documentation, assisting with quality improvement, and providing compliance audit and investigation support.

Duties/Responsibilities:

As directed by the Vice President of Legal & Regulatory Affairs and/or Senior Compliance Manager, the Compliance Specialist will perform functions including, but not limited to, the following:  

• Oversee all phases of import or export customs transactions, provides guidance for compliance regulations and policies/procedures and coordinates export licensing and requirements as it applies to a non-profit distributor with contracted warehouses worldwide.
• Creates and maintains an import and export control database and tracking system for country specific laws, regulations, and document requirements.
• Coordinate information and communication among Legal & Regulatory Affairs, Operations and Pharmacy & Clinical Affairs and Quality Management on issues concerning pharmacovigilance, including recalls.  
• Coordinate information and communication between Legal & Regulatory Affairs and Quality Management on matters concerning SOPs and discrepancies.
• Assist the Senior Compliance Manager in the day-to-day operation of compliance related programs and processes, including file management, record keeping and internal reporting. 
• Prepare for filing all drug distributor license applications and renewals (and related registrations) for federal and state authorities.  
• Prepare for filling all corporate registrations and license-related filings for all relevant jurisdictions.  
• Support the Senior Compliance Manager and Vice President with internal and external audits, including collating documents and creating summary reports.
• Support the Vice President’s corporate secretary’s obligations, including meeting minutes, presentations and corporate document management. 
• Advise and support the department’s response to external inquiries and internal investigations. 

Desired Qualifications: 

• Degree from a four-year university.  A combination of equivalent experience and education may be considered. 
• 3-5 years compliance, trade, or audit experience. 
• Versatility and flexibility – able to adapt to changing priorities.
• Outstanding communication (written and verbal) and interpersonal skills – able to work well with staff at all levels.
• Strong organizational and time management skills.
• Self-directed and detail oriented.
• Able to effectively manage multiple projects concurrently, independently and as part of a team.
• Ability to prioritize and work under a tight schedule, effective at meeting deadlines.
• Clear background check and toxicology screening.