The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
SUNRx (340B Holdings LLC), a subsidiary of MedImpact Healthcare Systems, Inc. , is looking for extraordinary people to join our team!
Why join SUNRx (340B Holdings LLC)? Because our success is dependent on you; innovative professionals with top notch skills who thrive on opportunity, high performance, and teamwork. We look for individuals who want to work on a team that cares about making a difference in the value of healthcare.
At SUNRx (340B Holdings LLC), we deliver leading edge pharmaceutical and technology related solutions that dramatically improve the value of health care. We provide superior outcomes to those we serve through innovative products, systems, and services that provide transparency and promote choice in decision making. Our vision is to set the standard in providing solutions that optimize satisfaction, service, cost, and quality in the healthcare industry. We are the premier Pharmacy Benefits Management solution!
The Compliance Manager manages and oversees compliance monitoring, including support of self-audit activities conducted by SUNRx’s clients, and support for audits and inquiries performed by external independent auditors and regulatory authorities, such as HRSA, States, or manufacturers. In addition, this position provides support related to client monitoring and auditing of SUNRx operations, and client contractual obligations.
What You Get To Do:
Serves as subject matter expert to ensure compliance monitoring/audit support activities are conducted effectively and efficiently
Provides direct support to clients during scheduled audits from regulatory agencies or manufacturers, as well as during client initiated self-audits
Evaluates external compliance monitoring/audit requests to determine scope, applicability, and impact on organization. Reviews any applicable regulatory requirements and contractual requirements. Advises SUNRx client teams of any applicable regulatory, contractual requirements or previous corrective actions pertinent to the compliance monitoring/audit activity
Coordinates support activities with internal operational areas as well as educates and trains employees on external compliance monitoring/auditing procedures. Oversees any corrective action plans related to adverse findings, including assisting clients with required HRSA reporting and developing manufacturer refund letters
Maintains corporate records of materials provided and received in compliance monitoring/audit support activities
Ensures notification of scheduled compliance monitoring and audits are scheduled, tracked, and communicated to organization appropriately
Manages communications of routine and changes in regulatory activity to SUNRx clients. Maintains tracking of notifications to clients
Responsible for Medicaid BIN management to include: researching state Medicaid BINs, quarterly reviews of those BINs, validation of known BINs, and analysis of Medicaid claims capture for 340B eligible claims
Responsible for working with the VP of Regulatory Affairs and Compliance on the development, publishing, and maintaining of regulatory policies & procedures to include 340B regulations and HIPAA compliance
Identifies and oversees the development of regulatory reports required to support client regulatory audits and self-audits
Develops and maintains standard compliance monitoring/auditing information on various topics that can be utilized by external entities performing compliance monitoring/auditing on SUNRx clients
Develops and maintains guidelines of standard materials to support specific compliance monitoring/auditing as requested by external entities. Maintains corporate records of materials provided to support compliance monitoring/auditing activities, including the specifications utilized to create data reports
Oversees and manages a formalized follow-up session with client team members, and management as appropriate, including follow-up on findings (e.g., corrective action plans). Works with affected areas to ensure findings are addressed and within stated timelines
Prepares and presents compliance monitoring, audit findings, corrective actions, and other relevant information to management
Assists the MedImpact Corporate Compliance Officer with 340B compliance program initiatives as well as educates and trains enterprise employees
Assists with any accreditation efforts as needed to include information gathering. Ensures standards are met; supports compliance assurance efforts related to SUNRx and subsidiary organizations
Education and/or Experience
For consideration candidates will need a Bachelor’s degree in a related field (or equivalent combination of education and experience) along with at least five (5) to eight (8) plus years’ related experience, including experience in the healthcare industry conducting and/or participating in regulatory authority audits and/or third party audits. Prior 340B Program and/or pharmacy experience a plus.
Candidates should have proficient experience with MS Office Suite (Word, Excel, PowerPoint), MS Outlook.
Other Skills and Abilities
Knowledge of HIPAA regulations
Ability to research, analyze, audit, and apply information to practices and standards
Strong analytical and problem solving ability
Excellent writing skills and interpersonal skills
Travel - This position requires domestic travel of up to 25% of the time.
Medical / Dental / Vision / Wellness Programs
Paid Time Off / Company Paid Holidays
401K with Company match
Life and Disability Insurance
Employee Referral Bonus
This position is eligible for Employee Referral Bonus at Level II
To explore all that MedImpact has to offer, and the greatness you can bring to our teams, please submit your resume to www.medimpact.com/careers
MedImpact, is a privately-held pharmacy benefit manager (PBM) headquartered in San Diego, California. Our solutions and services positively influence healthcare outcomes and expenditures, improving the position of our clients in the market. MedImpact offers high-value solutions to payers, providers and consumers of healthcare in the U.S. and foreign markets.
To perform this job successfully, the successful candidate must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Internal Number: 6482
MedImpact is an independent PBM that manages trend before it happens across all channels through One Source, at a Lower Cost, and delivers innovations for Better Care.