Compliance Specialist

The Role will be responsible to conduct monitoring and support administrative components necessary for Company to continue implementation of its effective, seven-element compliance program. The Role will report to the Senior Compliance Manager and carry out day-to-day monitoring activity required to be completed under Company's risk assessment and mitigation plan to ensure Company's compliance with fraud and abuse concerns in the development, marketing and sale of pharmaceuticals. The Role will support the Senior Compliance Manager by drafting monitoring reports for review, clearly communicating results of any findings, and implementing technology solutions to improve the Companys compliance program’s operational management of monitoring activity. Additionally, the Role will provide administrative support and/or contribute to a range of compliance-related projects to further the effectiveness of Company's seven-element compliance program.

Responsibilities;

Responsibilities

• Conduct and coordinate day-to day compliance monitoring to support compliance with the requirements of company’s compliance program risk assessment and mitigation plan; identify gaps in business operational processes and propose and recommend remediations by partnering with business leads and key stakeholders.
• Develop and generate accurate and complete monitoring results and findings, gathering supporting information and preparing reports of key trends and findings from these activities for timely communication to relevant stakeholders at the conclusion of monitoring and testing assessments.
• Help determine root causes associated with findings and obtain management's action plan for remediation in a timely manner and track actions through resolution verification and closure.
• Drive forward excellence in execution of the risk assessment and mitigation plan and supporting activities, identifying opportunities to enhance the program, where possible.
• Support maintenance of system for tracking outcomes and data associated with monitoring activities and support implementation of technologies to drive efficiency is capturing this data to drive toward systematic reporting/analytics.
• Provide administrative oversight of the pharma compliance group email box (e.g., support compliance management issue necessary communications, respond to requests received) in support of the overall pharma compliance program, including the program’s annual training and communications plans.
• Support compliance management in scheduling and communicating new hire and company-wide live trainings, assist with production during live training events, and work with the Learning Management team to document completions associated with training attendance.
• Provide administrative support in updating and maintaining company;s Compliance intranet and ComplianceConnect app content.
• Support compliance management develop written documentation/work instructions around the responsibilities outlined above.
• Performs other and related administrative duties as required.
  
  

Qualification:

Minimum BS/BA degree.

Healthcare Compliance Program certification related to life sciences industry a plus

Minimum of 3 years of experience in the pharmaceutical industry

Experience working in roles supporting compliance with federal healthcare program requirements is a plus.

Experience working in a multi-cultural, multi-lingual environment is a plus.

Strong organizational/project management skills; proven ability to simultaneously manage activities associated with multiple projects (e.g., scheduling, planning, and prioritizing) and initiatives.

Strong interpersonal & communication skills, verbal and written; communicates clearly and professionally.

Demonstrated knowledge of pharmaceutical regulatory landscape (Anti-Kickback Statute, PhRMA Code, False Claims Act, and OIG/DOJ Guidance)

Strong Excel, PowerPoint, data analysis and dash boarding skills