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.
ABOUT THE ROLE
This is an entry-level, early career opportunity.
Prepare, advocate, interpret, and communicate cellular therapy (CT)-related regulatory policy and CT 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.
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. Facilitate the development of position statements as needed.
Coordinate projects among the Public Policy, Regulatory and Cellular Therapy Departments for activities in the CT-related advocacy agenda
Monitor legislation, regulatory, and health policy developments through reviewing Internet sites and other published material.
Perform research regarding legislative, health policy and CT regulatory issues and CT related projects as needed.
Attend federal regulatory agency committee meetings, congressional hearings, presentations, advisory committee meetings, industry meetings, conferences and workshops and prepare summary reports or analyses as directed, representing AABB as the regulatory expert at these meetings.
Serve as the key contact for some 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 CT regulatory topics. Maintain surveillance of regulatory publications and actions and advise on proactive courses of action.
As directed, support the Center for Cellular Therapies, Regulatory Affairs, and 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.
Advocate AABB positions as needed. Coordinate AABB role in the CT FDA Liaison meetings.
Represent AABB at public meetings of FDA, HHS, and other governmental 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 regulatory affairs representative in committee meetings and conferences.
Provide support to CT section, such as the CT Quality, Regulatory and Management (QRM) and Spanish Language Subsection (SLS). Support and participate in other relevant committees and interorganizational task forces as directed. Facilitate the development of resources 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.
Serve as staff liaison for CT related projects such as the donor history questionaires and the Circular of Information for CT Products. Coordinate AABB committee functions for standing and ad hoc committees, working groups and task forces addressing policy matters as directed.
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 content, as needed, for the AABB web site. Review articles for Association newsletters. Regularly review CT regulatory web content to ensure information is accurate and up to date.
Provide CT regulatory and advocacy/policy support to the Communications department as needed.
Assist with relevant educational sessions at Annual Meeting, conferences and with other organizations as needed. Provide education and training to staff relating to key CT regulatory issues, as requested.
Our ideal candidate will have a passion for organizing information and will possess exceptional attention to detail. S/he will also have enthusiasm, be strongly self-motivated, and take pride in quality of work.
This is a great role for candidates with 1-3 years of experience, looking for an early career opportunity.
Bachelor’s degree required.
Experience in regulatory, advocacy, or public policy required.
Spanish language skills strongly preferred.
You have experience with and comfort in working in a fast paced, team-oriented environment with high expectations.
You have the ability to produce consistently high-quality work, independently and with minimal errors. You are a quick thinker, can effectively solve problems, and determine priorities under the pressure of deadlines.
You love taking on difficult challenges and finding creative solutions. You stay focused and get results.
You communicate clearly. You write well. You speak eloquently.
You think on your feet. You like learning new things, and you can learn quickly. When things change, you know how to roll with the punches.
You pay attention to details.
You are motivated and driven. You enjoy working on teams. You want to make a difference.
WHY SHOULD YOU APPLY?
We recognize and reward our most valuable asset—our team—with a generous leave and benefits package, and excellent educational and professional development opportunities.
Please apply with your cover letter and resume.
AABB is an equal opportunity employer.
No phone calls please.
AABB is the international association of blood banks, including hospital and community blood centers, transfusion and transplantation services and individuals involved in activities related to transfusion and transplantation medicine.More than 2,000 institutions (community and hospital blood banks, hospital transfusion services and laboratories) and 11,000 individuals are members of the AABB, including physicians, scientists, administrators, medical technologists, blood donor recruiters and public relations personnel. Members are located in all 50 states and more than 80 foreign countries.