Ethics and Business Integrity and Compliance Professional
Perform the operational and tracking needs for the execution of the live field force monitoring of speaker programs and HCP interactions. Will also perform the intake of reports from third party monitors and conduct quality reviews based on established internal standards and ensure proper retention in our internal Sharepoint sites.
Perform transactional monitoring of records for compliance with Company policies for non-promotional HCP engagements/consulting arrangements, speaker program expenses, HCP meals expenses, expense reports and other relevant compliance areas as needed. Identify anomalies from the monitoring and independently investigate, concluded, and report issues/results clearly to the managers of the field force monitoring team.
Create transactional testing scripts and monitoring procedures on an ad hoc basis for relevant compliance areas as needed.
Combine data output from various systems to compile reports that will be utilized by the field force monitoring team for the monitoring selection process.
Will utilize Microsoft Excel to conduct data analyses of large amounts of data pulled from various systems.
Lead the execution of the weekly field force monitoring records review requests from various business partners.
Lead the accurate tracking of monitoring observations and assist with the compilation of the monitoring results to business leadership on a quarterly and ad hoc basis. Will also assist with preparing presentations using charts and graphs in Microsoft PowerPoint.
Maintain the field force monitoring team's Sharepoint site and relevant monitoring documentation.
Report observations, remediation, and anomalies to the Lead Mandated Monitoring in a manner that leads to resolution.
The individual will take on compliance monitoring projects on an ad hoc basis and interact with relevant areas of the business (commercial, medical, legal, regulatory, and/or business operations) and should have the ability to establish strong working relationships. The individual will execute the projects from start to finish with minimal supervision. This can include assisting with follow up with regulatory and legal required as a result of records review (i.e. emails, call notes, etc) promotional messaging content items flagged for review.
Education - Bachelor's degree
2 years of experience in pharmaceutical compliance (Preferred)
Monitoring/Auditing/Quality experience or equivalent
Organized and detail oriented with a strong compliance mindset
Sound written and verbal communication skills
Experienced in data analysis
Sound business acumen, analytical and problem-solving skills, and ability to present complex information
Must be proficient in Microsoft Excel, Word, and PowerPoint. Must be able to adjust to the changes in the business quickly in order to successfully navigate the various applications and systems.
Be able to work independently with minimal supervision in a fast-paced environment and handle multiple tasks.