Position Title: Coordinator, Science and Regulatory Affairs
Department: Health/Policy Department
Reports to: Managing Director, Science and Regulatory Affairs
The primary purpose of this position is to provide administrative and professional support to the Managing Director for Science and Regulatory Affairs.
Provide administrative support to the Managing Director for Science and Regulatory Affairs, and through him to others in the Policy Department, as required. This may involve:
tracking department projects (such as submissions to the FDA docket) and helping to ensure adherence to due dates
scheduling appointments and conference calls
scheduling and organizing internal and external face-to-face meetings, which often require set-up, clean-up, and arranging for catering
answering telephone calls and taking messages or fielding/answering routine questions as appropriate, in a professional and timely manner
formatting, copying, and distributing correspondence, policy documents, and power point presentations and managing working group distribution lists
as authorized, ensuring that policy documents are posted to BIO’s website
arranging and confirming departmental travel
ordering office supplies
tracking and processing contracts, invoices, and expenses
tracking of science and regulatory affairs budget and projections
Provide professional support to Policy Department staff and to select BIO working groups in the Policy Department, as requested by the Managing Director, Science and Regulatory Affairs. This may involve:
monitoring key developments related to BIO’s policy priorities, and distributing information about these developments to relevant BIO staff and working groups
moderating and sometimes leading working group conference calls
given BIO’s policy goals and strategy, helping working groups to identify appropriate objectives, action items, and timelines
writing up action items (and sometimes meeting summaries), and working with those responsible for action items to ensure adherence to timelines
keeping management informed of working groups’ activities – in particular, informed of any actual or potential policy-related concerns – and asking for help whenever needed
contributing to BIO’s policy development activities by providing management with timely, comprehensive, and relevant input on policy issues
reporting on policy issues to other BIO staff and to BIO members, sometimes including members of the BIO Board
acting as BIO point person for certain FDA staff, for example for FDA Meetings Management staff as we plan BIO/FDA leadership meetings.
Contribute articles to BIO publications, departmental newsletters, and blogs.
Conduct basic research (data collection and analysis) on policy topics. This may include attending meetings held by federal agencies or hearings on the Hill.
Become familiar with the work of the Policy Department and 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.
Back up other Policy Department staff, as required by the Managing Director, Science and Regulatory Affairs. This may include anything from administrative/clerical tasks to hosting/leading meetings.
Provide one hour of coverage at the receptionist desk when called upon based on the rotating schedule.
Other duties/projects as assigned.
Excellent communications skills, including writing and speaking skills
Excellent research skills, including problem-solving ability and attentiveness to detail
Familiarity with the Microsoft computing environment (for example, Word, Excel, Powerpoint, Explorer).
Familiarity with standard office machines.
High School Diploma or GED required, preferably in science or health policy-related topics
Bachelors degree preferred, preferably in science or health policy-related topics
Masters degree a plus, preferably in science or health policy-related topics, or in business
2-4 years related experience (for example, work in policy development for a biotech company, trade association, legislative office, or regulatory agency)