Director, Science and Regulatory Affairs @ BIO

Biotechnology Industry Organization

1201 Maryland Avenue SW, Suite 900
Washington, DC 20024
jmcgrath@bio.org

www.bio.org

JOB DESCRIPTION

Position Title: Director, Science and Regulatory Affairs
Department: Health Section
Reports to: Managing Director, Science and Regulatory Affairs

Primary Purpose of the Position:

The primary purpose of this position is to work with BIO’s science and regulatory affairs team to monitor and manage science and regulatory issues of importance to the biotechnology industry. These issues will be primarily related to activities of the Food and Drug Administration (FDA), but may also include other issues identified as priorities by the BIO Board of Directors.

Essential Job Duties and Responsibilities:

1. Monitor federal and state regulatory activity (including the development of new regulations and guidance documents) of importance to BIO’s healthcare-focused companies. Coordinate the development and approval of written responses to the docket, and verbally communicate BIO positions to relevant government officials.
2. Contribute to the planning and hosting of dialog sessions with regulatory agencies on behalf of BIO companies and attend meetings held by federal agencies or hearings on the Hill.
3. Conduct research into scientific and regulatory issues as required, in particular for the Health Section, the Federal Government Relations Department, and the Communications Department.
4. Disseminate relevant information on scientific and regulatory issues to other BIO staff and to member companies. This includes regular reporting at meetings of the BIO Regulatory Affairs Committee and Federal Government Relations Committee.
5. Coordinate all BIO activity and issues related to:

 Preclinical safety,

 Clinical safety and efficacy,

 Modernizing regulatory science, and

 Manufacturing issues.

This includes, for example, staffing working groups of company experts (preparing for meetings, writing up action items and ensuring these action items are completed), drafting policy positions, acting as point person for certain FDA staff, and reporting on these issues and related developments to other BIO staff and BIO working groups.
6. Assist in policy development related to other healthcare biotech issues, as assigned. Such issues may include, for example, FDA Human Drug Review, Biosimilars, Drug Safety, Pediatrics, and Pharmacogenomics.
7. Contribute articles to BIO publications, including BIO News and departmental newsletters and blogs.
8. Contribute to the maintenance and enhancement of the “Health Care” and “Regulatory” sections of BIO’s website, so that these pages provide up-to-date information for members and the public on key developments affecting our industry, and related BIO policy and advocacy.
9. Become familiar with the work of the Health Section as a whole and with BIO’s overall priorities, and help to ensure that scientific and regulatory work is well-integrated with other activities at BIO.
10. Handle requests from other BIO staff and BIO members quickly, professionally and effectively, seeking help and guidance from management as needed.
11. Back up all other health section staff, as required. This may include anything from hosting/leading meetings to administrative/clerical tasks when necessary.
12. Fulfill other duties/projects as assigned.

Knowledge and Skills Required:

• Excellent communications skills, including writing and speaking skills
• Excellent research skills, including problem-solving ability and attentiveness to detail
• Team player
• Familiarity with the Microsoft computing environment (for example, Word, Excel, PowerPoint, Explorer).
• Familiarity with standard office machines.

Education and Experience Required:

• Bachelors degree required, preferably in science or health policy.
• Masters degree preferred, preferably in science or health policy.
• 5+ years related experience (for example, work in policy development for a biotech company, trade association, legislative office, or regulatory agency)