Director, Compliance - Auditing & Monitoring

Location: 

Philadelphia Area - Radnor, PA, PA, US

The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients.  In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

 

Headquartered near Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania.  Idorsia is committed to meet the changing needs of healthcare professionals, patients and their families.  The core of what we do is to bring creative solutions to the market based on our science and data.

 

The Director, US Compliance Auditing and Monitoring is responsible for identifying current Compliance risk areas and establishing auditing and monitoring approaches to evaluate company adherence to US regulations and Idorsia Policies and Procedures.   This role will be expected to use technology, analytics and traditional live monitoring and records review activities to help Idorsia’s US business identify and appropriately remediate potential concerns.  These activities will include, but not be limited to, planned risk assessment and subsequent monitoring/auditing activities as well as ad hoc assessments and investigations necessitated because of helpline communications or monitoring/auditing finding. 

 

Key Responsibilities:

 

  • Conducts live field monitoring of Commercial and Medical Affairs activities. 
  • Conducts transactional monitoring of records and systems including but not limited to: patient assistance programs, arrangements and interactions with Independent Charity PAPs, expense reporting, medical information requests, educational grants and other external funding requests and consulting and advisory engagements with healthcare providers.
  • Prepares reports, presentations, and dashboards for numerous audiences, including Idorsia Leadership and the Idorsia Compliance Committee, that summarize monitoring and auditing findings and remediation.
  • Develops and implements an appropriately scaled risk assessment and management process and prioritizes monitoring activities and mitigation plans in accordance with that process.  
  • Oversees the remediation and corrective action process for the Compliance team.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations carried out by the Compliance Department.
  • Develops appropriate data analytics and use of innovative technology to expand and advance monitoring capabilities.
  • Contributes as needed to the preparation of Government reporting, including reports required under the Open Payments law and state law monitoring and reporting.

 

Qualifications:

 

  • Minimum of 10 years of healthcare compliance monitoring and auditing experience with a pharmaceutical/biopharmaceutical company or within the life sciences industry. 
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute, False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically the PhRMA Code on Interactions with Healthcare Professionals.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Ability to interact with Idorsia employees at all levels of the organization.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail oriented.
  • Highest level of ethics and personal integrity.
  • Ability to travel domestically up to 25%.

 

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

 

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

 

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.


Nearest Major Market: Philadelphia