AABB is an international, not-for-profit association representing individuals and institutions involved in the fields of transfusion medicine and cellular therapies. The association is committed to improving health through the development and delivery of standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership includes physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries and AABB accredits institutions in over 50 countries.
AABB is seeking a Specialist to prepare, advocate, interpret, and communicate CT-related regulatory policy and Transfusion Medicine related policy/advocacy activities for the Association and its members. Work as directed with federal and other relevant agencies, as well as AABB staff to ensure communication of member and association concerns. This position supports cellular therapies activities 60% and public policy 40%.
- Support efforts related to regulatory affairs in the Center for Cellular Therapies in providing analysis and proposing positions on cellular therapies-related policy issues for the Board of Directors and senior management.
- Coordinate projects among the Public Policy, Regulatory and Cellular Therapy Departments for activities in the CT-related advocacy agenda
- Monitor and report on legislation, regulatory, and health policy developments through reviewing Internet sites and other published material.
- Perform research regarding legislative, health policy and CT regulatory issues.
- Attend federal regulatory agency committee meetings, congressional hearings, presentations, advisory committee meetings, industry meetings, conferences and workshops and prepare summary reports as directed
- Serve as the key contact for CT-related partnerships and alliances to help ensure alliances are maximized to meet strategic goals.
- Draft, edit and submit AABB positions on proposed rules, guidance documents and items for regulatory advisory committee discussions. Maintain surveillance of regulatory publications and actions and advise on proactive courses of action.
- As directed, support the Center for Cellular Therapies, Director, Regulatory Affairs, and Director of Public Policy as a focal point for CT related communications with regulatory and public health agencies, including FDA, CMS, CDC and other HHS offices and departments. Represent AABB in meetings with governmental agencies, as designated. Advocate positions as needed. Coordinate AABB role in the CT FDA Liaison meetings.
- Represent AABB at public meetings of FDA, HHS, and other agencies as directed. Monitor meeting dates and agendas, and determine need for AABB to make public statements. Prepare statements as needed. Participate in development of public workshops as requested. Serve as AABB representative in meetings and conferences as directed.
- Serve as the staff liaison to the CT Regulatory Affairs subsection. Support and participate in other relevant committees and interorganizational task forces as directed. Facilitate the development of position statements, Association Bulletins, and other materials such as the donor history questionnaire, CT Circular of Information and other work products or materials as needed. Participate in review processes of these work products from committees and task forces, both internal AABB review, and external with regulatory agencies, as appropriate
- Coordinate AABB committee functions for standing and ad hoc committees, working groups and task forces addressing policy matters.
- Serve as the key contact and coordinator of communication related to reimbursement and legislation issues for cellular therapy. Serve as the liaison to Public Policy Department to accomplish CT related advocacy objectives and goals.
- Provide assistance to members and staff with CT regulatory or policy questions. When necessary, contact the regulatory agency directly to obtain answers. Determine the need for communication with members on policy and regulatory issues.
- Develop contacts and maintain open lines of communication on regulatory matters with other cellular therapy and related organizations.
- Develop CT regulatory and CT and TM policy content, as needed, for the AABB web site and articles for newsletters. Regularly review web content to ensure information is accurate and up to date.
- Provide CT regulatory and advocacy/policy support to the Communications and Public Relations departments. Advice on content for association communication as needed.
- Assist with relevant educational sessions at Annual Meeting and with other associations and organizations as needed.
- Provide education and training to staff relating to key CT regulatory issues, as requested.