Sunshine Act Compliance Consultant

Sunshine Act Compliance Consultant
Temporary/Contract Assignment
Medela/Medaxis in McHenry, IL
*This is not a remote position and will require coming onsite to our McHenry, IL location.

We are seeking an experienced Sunshine Act Compliance Consultant to lead our annual Open Payments reporting process and train our internal team on regulatory requirements, data collection, reporting, and best practices.

This individual must be a subject matter expert in the U.S. Physician Payments Sunshine Act and have hands-on experience preparing and submitting Open Payments data through the CMS reporting system.

The consultant will evaluate our current processes, identify reportable transactions, work cross-functionally to gather and validate required data, prepare the annual reporting files, and develop sustainable procedures that enable our internal team to successfully manage future reporting cycles.

Key Responsibilities

• Serve as the company's subject matter expert on the Physician Payments Sunshine Act (Open Payments) regulations.
• Interpret Sunshine Act requirements and advise stakeholders on reportable payments, transfers of value, ownership interests, and applicable exclusions.
• Lead the annual Open Payments reporting process from data collection through submission.
• Review existing business processes and identify improvements to ensure ongoing compliance.
• Partner with Compliance, Finance, Sales, Marketing, Medical Affairs, Accounts Payable, Procurement, Travel & Expense, and other business functions to collect required reporting data.
• Identify all reportable transactions and ensure proper categorization based on CMS reporting requirements.
• Validate data accuracy, reconcile information from multiple systems, and resolve discrepancies prior to submission.
• Prepare and review reporting files for submission through the CMS Open Payments system.
• Ensure all required documentation is maintained to support audits and regulatory inquiries.
• Develop standard operating procedures (SOPs), reporting templates, and process documentation for future reporting cycles.
• Train internal employees on Sunshine Act regulations, reportable events, documentation requirements, and annual reporting procedures.
• Provide recommendations to improve data collection processes, internal controls, and compliance practices.
• Serve as the primary resource for Sunshine Act questions throughout the engagement.

Required Qualifications

• Demonstrated subject matter expertise in the U.S. Physician Payments Sunshine Act (Open Payments).
• Experience independently preparing and submitting annual CMS Open Payments reports.
• Thorough understanding of CMS reporting requirements, reportable transfers of value, ownership reporting, dispute resolution, and applicable exclusions.
• Experience working in the medical device, pharmaceutical, biotechnology, or healthcare industry.
• Strong knowledge of healthcare compliance regulations and industry best practices.
• Advanced Microsoft Excel skills, including Pivot Tables, XLOOKUP/VLOOKUP, formulas, and data analysis.
• Experience extracting, reconciling, and validating data from ERP, finance, expense management, and CRM systems.
• Exceptional analytical, organizational, and problem-solving skills.
• Proven experience developing compliance processes, documenting procedures, and training business users.
• Ability to communicate complex regulatory requirements to non-technical stakeholders.
• High attention to detail with the ability to manage confidential and sensitive information.

Preferred Experience

• Previous experience serving as the lead or primary resource for Sunshine Act/Open Payments compliance.
• Experience supporting internal or external compliance audits.
• Experience improving reporting processes and implementing compliance controls.
• Experience working in a global medical device or pharmaceutical organization is preferred.

This is a temporary assignment:
The assignment will continue until the Sunshine Act reporting process has been successfully established, all required reporting activities are complete, and designated employees have been fully trained to independently manage future reporting cycles. If the consultant possesses additional skills that align with our business needs, there may be an opportunity to extend the assignment to support other compliance or business initiatives.

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