Director, Regulatory Affairs
- Experience Level
Based in Atlanta, GA the American College of Rheumatology is a professional association for physicians, health professionals, and scientists that work in the medical subspecialty of rheumatology. The ACR has over 9,500 members from around the world. We offer a variety of services, including: educational programming, legislative and regulatory advocacy, practice management support and grant funding through its Rheumatology Research Foundation. The ACR’s Annual Scientific Meeting, held each fall, is the premier scientific meeting in the world devoted to rheumatic diseases. To find out more about us please visit www.rheumatology.org
AMERICAN COLLEGE OF RHEUMATOLOGY
TITLE: Director, Regulatory Affairs
POSITION #: 112
DATE: September 2019
LOCATION: Washington, D.C.
DIRECT SUPERVISOR: Senior Director, Government Affairs
POSITION SUMMARY DESCRIPTION:
The Director, Regulatory Affairs will be responsible for driving the ACR’s regulatory efforts, and will develop and execute effective strategies related to regulations and agency issues that affect the rheumatology community. They will oversee and provide expertise, counsel, and guidance related to the ACR’s interactions with regulatory agencies and the organization’s responses to rules, proposed rules, guidance and other proposals and regulations. The individual will serve as one of the lobbyists for the ACR and will represent the organization at meetings of agencies, commissions, specialty societies and coalitions. They will effectively engage with key stakeholders and coalition partners to advance the ACR’s regulatory agenda.
AREAS OF RESPONSIBILITY:
- Develop and execute strategy related to regulations and issues affecting access to rheumatologic care, including Medicare Physician Fee Schedule updates; implementation of the Quality Payment Program (QPP); and appropriate reimbursement for rheumatologists and rheumatology services.
- Develop and execute regulatory strategy related to access to appropriate and effective treatments, such as appropriate reimbursement, naming, labeling, and interchangeability guidance for biosimilar products; resolving drug cost attribution under the Quality Payment Program; along with appropriate reimbursement for complex infusion administration and other Medicare Administrative Contractor (MAC) issues.
- Develop and execute strategy to help rheumatologists perform under the Medicare Quality Payment Program, including leveraging qualified clinical data registries (QCDRs) such as the ACR’s RISE registry; implementation of ACR-developed quality measures for rheumatology; and addressing additional physician requirements.
- Serve as one of the lobbyists for the ACR and maintain relationships with agency staff at CMS, FDA, NIH, GAO, MedPAC, and other agencies and commissions. Represent the ACR at meetings of agencies, commissions, specialty societies and coalitions. Engage with coalitions and develop partnerships with physician societies and patient advocacy groups in relation to shared regulatory objectives. Effectively work with key stakeholders and allied organizations to advance the ACR’s policy agenda.
- Work collaboratively with ACR staff and volunteer leaders to respond to agency rules and proposals. Develop ACR comments and correspondence related to agency rules and proposals.
- Develop policy position statements and correspondence on regulatory issues. Prepare effective advocacy materials including background papers and issue briefs for various policy initiatives. Effectively communicate regulatory developments and advocacy activities to the membership, leadership, and grassroots networks.
- Regular communication with the Atlanta office including conference calls and emails.
- Any other duties as the Sr. Director, Government Affairs; Vice President, Practice, Advocacy, and Quality; or the ACR Executive Vice President may assign.
- Bachelor’s degree or equivalent experience and 5-10 years of related professional experience; health policy experience strongly preferred
- Master’s degree in public policy, public health, health services administration or similar area, or equivalent work-related experience highly desired
- Significant experience with regulatory processes, agency lobbying, and analysis and response to regulations and proposed regulations, especially in the health policy arena; understanding of physician payment and healthcare quality
- Outstanding writing and verbal communication skills, with the ability to make persuasive presentations and to distill highly complex documents in communications
- Excellent interpersonal skills with the ability to work with volunteers and staff effectively
- Ability to effectively interact with a wide variety of individuals and develop an extensive professional network, to include physicians and other health care professionals, regulatory agency staff, and other medical association government affairs professionals
- Self-starter with the ability to organize and manage several projects simultaneously and with minimal supervision; ability to exercise judgment in prioritizing responsibilities
- Highly detail-oriented with demonstrated analytical and problem-solving skills
- Not-for-profit experience highly desired; healthcare association experience preferred
The ACR provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. The ACR complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities or conducts business.
This is not a contract. The description and duties as they relate to this position are subject to change as reasonable business necessity dictates. In the event of such changes, a new job description may be created.