Coordinator, Science and Regulatory Affairs

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Position Title: Coordinator, Science and Regulatory Affairs         

Department:  Health/Policy Department

Reports to: Managing Director, Science and Regulatory Affairs                           

Position summary: 

The primary purpose of this position is to provide administrative and professional support to the Managing Director for Science and Regulatory Affairs. 

Responsibilities:

 

  1. 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

 

  1. 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. 

 

  1. Contribute articles to BIO publications, departmental newsletters, and blogs.

 

  1. Conduct basic research (data collection and analysis) on policy topics.  This may include attending meetings held by federal agencies or hearings on the Hill.

 

  1. 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.

 

  1. 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. 

 

  1. Provide one hour of coverage at the receptionist desk when called upon based on the rotating schedule.

 

  1. Other duties/projects as assigned.

 

 

Requirements:

  • 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.
  • 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)

 

 

 

 

 

 

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