Summary of Position:

The Regulatory Affairs Manager monitors regulatory issues within designated areas and identifies opportunities to engage with government agencies including those within the Department of Health and Human Services (HHS) to further advance the mission and priorities of the Immune Deficiency Foundation (IDF). Working with the Chief Public Policy Officer, this position will draft responses to a prescribed set of regulatory and reimbursement-related issues and represent the organization before state and federal agencies. This position will represent the organization to the public and interact closely with other staff members, particularly those involved in patient services, research, and communications. This position will work virtually but must be located within commuting distance to Washington DC (DMV) and able to travel into DC for regular meetings.

Position Responsibilities:

· Monitor, analyze, and draft responses to a prescribed set of regulatory and reimbursement-related issues and represent IDF before state and federal agencies.

· Engage with the agencies, including but not limited to centers within the HHS such as, the Centers for Medicare and Medicaid Services (CMS), and Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), as well as state health departments, state Medicaid offices, and insurance commissions.

· Work on issues related to Medicare coverage determinations, Medicaid coverage and preferred drug list determinations, FDA drug development and safety policies, agency guidance policies related to patient engagement and diversity equity and inclusion (DEI) impacting health access, clinical trials, and research opportunities.

· Monitor regulatory issues in defined areas and identify opportunities to advance IDF’s priorities.

· Participate in patient advocacy coalitions focused on regulatory issues and recommend what issues IDF should engage in.

· Work with appropriate staff and partners to prepare regulatory comments and correspondence to state and federal agencies.

· Maintain and develop new relationships with federal agency staff and coalition partners.

· Serve as a resource to other advocacy staff on regulatory issues impacting legislative and payer issues.

· Support and collaborate with other policy team members.

· Attend virtual and in person advisory committee meetings, federal agency meetings, coalition meetings, issue briefings and hearings as necessary.

Education:

• Juris Doctorate or Master’s degree in Public Policy, Public Administration, Political Science or related field desirable or equivalent Experience.
• Experience working within a governmental agency focused on health or for a patient advocacy organization on regulatory matters.

Experience:

· Minimum of four (4) years of experience in and knowledge of regulatory affairs.

· Knowledge of federal executive branch procedures and policies.

· Knowledge of health care access issues and prior experience writing regulatory comment letters and interacting with policymakers.

· Ability to identify issues and opportunities in the regulatory environment that will help advance the mission of IDF.

· Excellent writing and oral communication skills and the ability to think analytically.

· Ability to operate with minimum supervision, take initiative, and produce results.

Requirements:

· Must live within commuting distance from Washington, DC (DMV)

· Work virtually, but able and willing to attend meetings in the DC area on a weekly basis

Proficiency in the following software programs is necessary for this role:

· Microsoft Office, including Word, Excel, PowerPoint, Outlook

· Internet Browsers (Firefox, Chrome, Internet Explorer)

· CRM software

· Enterprise resource planning ERP software

· Project management software

Job Competencies:

Universal Competencies for All Staff:

Details key behaviors necessary for each employee to perform effectively across whole organization. Target behaviors guide the goal setting and performance evaluation process. As each employee ascends in their career journey, they cultivate and utilize the new skills they acquire at each level.

· Adaptability: Adapts well to changes in assignments and priorities; adapts behavior or work methods in response to new information, changing conditions, or unexpected obstacles; approaches change positively and adjusts behaviors accordingly.

· Communication: Uses effective and accurate writing and speaking skills; clearly conveys and receives information to others in a timely manner that engages the audience, helps them understand the message, and invites responses; includes all relevant team members when sharing information.

· Customer/Client Focus: Makes customers (both internal and external) and their needs a primary focus of one’s actions; developing and sustaining customer relationships.

· Planning and Organizing: Organizes work, sets priorities, and determines resource requirements; determines necessary sequence of activities needed to achieve goals in a complete and timely manner.

· Teamwork: Participates as an active and contributing member of a team to achieve team goals. Builds strong work relationships and adjusts to how individuals and organizations function and react. Responds positively to feedback and incorporates it into work. Works cooperatively with other team members, involves others, shares information as appropriate, and shares credit for team accomplishments.

Competencies for Managers of Process:

Details key behaviors necessary for each employee to perform effectively in their specific role. Target behaviors guide the goal setting and performance evaluation process. As each employee ascends in their career journey, they cultivate and utilize the new skills they acquire at each level.

· Work Standards: Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.

· Managing Work: Shows ability to plan, schedule and direct work of self and others. Balances task requirements and individual abilities. Sets challenging yet achievable goals for self and others. Comfortably delegates responsibilities, tasks, and decisions; appropriately trusts others to perform; provides support without removing responsibility.

· Decision Making/Problem Solving: Identifies and understands issues, problems, and opportunities. Compares data from different sources to draw conclusions. Analyzes problems into components and recognizes interrelationships with an awareness of strategic priorities and objectives; makes sound, well-informed, and objective decisions. Compares data, information, and input from a variety of sources to draw conclusions; takes action that is consistent with available facts, constraints, and probable consequences.

Job Type: Full-time

Pay: $65,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Experience level:

• 4 years

Schedule:

• Monday to Friday

Ability to Relocate:

• Washington, DC: Relocate before starting work (Required)

Work Location: In person