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Compliance Manager

Compliance Manager

The Compliance Manager provides overall support to RedHill’s Corporate Compliance Program. This role focuses on compliance as it relates to laws, regulations, and industry codes affecting the pharmaceutical business, including FDA regulations, False Claims Act, Anti-Kickback Statue, OIG guidance, PhRMA Code, and state and federal marketing and disclosure laws. 

This position is in our Raleigh, NC office.

Minimum Qualifications:

A Bachelor’s degree, preferably with a focus in science.  Two years within the commercial side of a pharmaceutical or biotechnology company or equivalent; substantive experience in healthcare compliance, promotional regulatory or legal functions is preferred.  Demonstrated strong commitment to compliance, ethics and accountability.  Domestic travel of up to 20%.

Principal Responsibilities:

The primary role of the Compliance Manager is to serve as the “data steward” to support all business areas in complying with Aggregate Spend laws and regulations. In this capacity, the Compliance Manager is the primary contact, support resource, liaison, and coordinator in the following areas:

  • Manual data capture and submission.
  • Maintenance and management of HCP data.
  • State and federal HCP payment reporting and monitoring.
  • PDMA sample management requirements and field audits.

The Compliance Manager is responsible for a variety of additional compliance-related activities including but not limited to data management, reporting, monitoring and auditing related to promotional activities and interactions with HCPs to ensure compliance with federal, state and local statutes, regulations and rules. This position is also responsible for a variety of general administrative tasks associated with Compliance Department functions. The position interacts with and serves as the point of contact for various departments within the company on compliance-related activities.

Serve as the Aggregate Spend data steward

  • Work with business areas to capture HCP payments in the appropriate format.
    • Review the information provided by the business, obtain missing required data, update HCP data against the customer record in RedHill’s data warehouse, add new HCPs to the Customer Master, as necessary.
    • Submit validated data into the aggregate spend reporting system. Cleanse and resubmit any data rejected by the system.
    • Prepare and file federal and state physician payment reports in accordance with marketing laws, including the Physician Payments Sunshine Act and similar state statutes.
    • Review aggregate spend system reports, maintain and monitor system alerts, and execute system updates as necessary.
  • Audit corporate records of activities as it applies to maintenance of Compliance requirements such as speaker programs, advisory boards, and grant activities and, where necessary, implement appropriate procedures to ensure adequate documentation of these activities.
  • Work with outside vendors
  • Engage in activities designed to monitor RedHill employee compliance with policies and education requirements as they pertain to HCP spend and PDMA requirements.
  • Compile metrics and assist in analyzing monitoring results.
  • Implement, under the supervision of the Director of Compliance, additional ad hoc projects on compliance issues.

 

If you are interested in applying for an Open Position, please follow the directions below: 

  1. Submit your resume to redhillemployment@redhillus.com

  2. In the subject line put the full job title of the position you are applying for (including city), your name and the date of your submission. Note that we will only consider applicants that specify the Open Position that they are applying for.

  3. Cover letters are optional.


We offer a Comprehensive Benefits package that includes:

  • Medical, Dental, and Vision Coverage
  • Domestic Partner Coverage
  • Life Insurance
  • Short-Term and Long-Term Disability
  • Flexible Spending Accounts (Healthcare and Dependent Care)
  • Employee Assistance Plan
  • 401(k)

Job Applicants should be aware of job offer scams that are committed though the use of the internet and social media platforms. All legitimate correspondence from a RedHill Biopharma employee will come from a “@redhillus.com” or “@redhillbio.com” email address.