No current openings

No current openings

Title: Patient Advocacy Case Manager

Job Code: TO- 07133-W

 

Job Profile

The Revenue Management Team is responsible for creating revenue by successfully overturning denied claims, while being a centralized resource for patients, centers, and providers, for appeals related issues. The Patient Advocacy Case Manager is responsible for processing advanced level appeals involving multiple layer payer types, including Commercial, Medicaid and Managed Medicaid, Workers’ Compensation, PIP, IPA, and Medicare Federal.  The Patient Advocacy Case Manager’s primary role is to call on the payers to overturn negative reimbursement decisions through the appeal process. This role is expected to work with anyone involved with a patient reimbursement related issue. This may include the patient, the payer, the billing department, the provider, employers, and external review agencies. This person is part of a reimbursement team responsible for influencing positive payer coverage decisions.  The Patient Advocacy Case Manager must establish credibility and develop a productive relationship with customers to produce favorable results.

 

Responsibilities:

• Process appeals and other patient advocacy related issues
• Partners with XDx functional departments to enhance overall business growth and profit
• Assist in the execution of payer strategies based on business and customer needs
• Interact with regional and national organizations and other professional groups regarding reimbursement and patient support issues
• Interact with Patient Advocacy, Benefit Specialists, billing department, payer contracting, Transplant Account Managers and other XDx departments to support customer base regarding reimbursement and patient advocacy issues
• Act as a highly technical resource to both internal and external customers
• Follow and maintain SOPs and data process guidelines and help identify opportunities for improvement in the Revenue Management Team

 

Qualifications:

• Bachelor’s degree required (business or life sciences preferred).  Graduate degree preferred  but not required
• Minimum of 3 years of insurance reimbursement experience at a pharmaceutical, diagnostics, or medical device company or 3 years of insurance experience in transplant, appeals management and/or contracting (Billing and/or claims experience preferred
• Intermediate to expert knowledge of insurance industry (including private payers, Medicare and Medicaid)
• Excellent communication skills are required: Must be able to effectively communicate and work successfully across disciplines
• Must apply problem solving abilities on a routine basis with little or no supervision
• Excellent multi-tasking skills: Must be able to manage multiple projects and deadlines effectively
• Excellent relationship skills: Must be able to effectively work in a team environment and leverage relationships in order to meet company goals
• Must be proficient in Microsoft Office (Excel, Word, Outlook, PowerPoint) and the internet
• Must be able to evaluate developments in the insurance, transplant and laboratory fields and incorporate the developments into Revenue Management strategic planning
• Must be detail oriented, self motivated, and capable of researching information above and beyond the data directly presented including laws and statues in an effort to resolve reimbursement obstacles
• Must be able to analyze data to determine trends and detect collection problems, identify possible courses of action and recommend an appropriate solution

 

Interested in applying for this job?

Please email your statement of interest and resume to jobs@xdx.com. Please specify which position you are applying for by including the Job Code in the subject line of your email. If possible, submit resume as a Word document. Principals only please.

 

XDx is an Equal Opportunity Employer

No current openings

No current openings

Title: Director, Regulatory Affairs/Quality Assurance

Job Code: RA-07162-W

 

Job Profile

The Director, RA/QA is responsible for working with all stakeholders to define and implement the company’s regulatory strategy in support of CLIA, ISO, FDA submission and QSR regulations and to oversee the Quality Management System.  The Quality Management System must support all company regulatory requirements and ensure the quality, safety and reliability of the company’s products and compliance with industry and government standards. This position will oversee implementation of Design Control for products regulated by the FDA. In addition, the position will oversee the company’s document control function.

 

Responsibilities include, but not necessarily limited to:

• Play a leading role in defining the regulatory and quality strategy to support product commercialization
• Serves as the management representative for the XDx Quality System
• Serves (or delegates) the primary interface with regulatory bodies for non-CLIA-related operations
• Establish and manage a Quality Management System
• Drive the development, implementation and monitoring of Quality System processes, including (but not limited to) management responsibility, quality audits, personnel, design control, purchasing controls, CAPAs and complaints
• In close collaboration with Marketing, Sales and Research and Development, work as a business partner to review education materials, training programs, and technical documentation provided outside of the company. 
• Play an active role with other industry Regulatory Affairs professionals and represent the company on cross-company regulatory initiatives. 
• Create, implement, and manage a regulatory training program for employees

 

Qualifications:

• BA/BS/PhD (preferred) in biological science or chemistry
• 7+ years Regulatory Affairs and QA experience within the in-vitro diagnostics industry
• Experience with post market IVDM support
• Experience with FDA, CLIA audits and inspections
• Experience working and/or leading cross functional teams
• Previous FDA regulatory submission experience (e.g. 510(k), PMA, PLA)
• Familiarity with ISO 13485  regulations
• Experience in a CLIA-regulated laboratory environment desirable
• Experience with IVD Multivariate Index Assay (IVDMIA)  products desirable
• Experience with developing and implementing GLP and GMP
• Ability to network with government  regulatory personnel

 

Interested in applying for this job?

Please email your statement of interest and resume to jobs@xdx.com. Please specify which position you are applying for by including the Job Code in the subject line of your email. If possible, submit resume as a Word document. Principals only please.

 

XDx is an Equal Opportunity Employer