Regulatory Affairs Administrative Coordinator
This position provides support for the daily operations of the Regulatory Affairs department as well as general office operations. The incumbent will provide administrative support for programs and initiatives carried out by ISPE volunteer groups, and will be responsible for tracking, summarizing and disseminating information on these groups to various sources. Responsibilities also include preparing and assembling ISPE commentary on regulatory documents and communications related to regulatory speakers.
Principal Duties and Responsibilities
Regulatory Affairs support
- Compose regulatory speaker invitation letters; create regulator itineraries.
- Write summaries of regulatory volunteer groups’ activity to publish in ISPE vehicles.
- Maintain a record of regulatory groups’ activities and plans; use for various tasks, including:
- Updating project tracker Excel sheets for Regulatory Affairs department and Board of Directors.
- Creating summaries of regulatory committees’ activities to share with other ISPE groups.
- Create and/or update presentations as needed.
- Work with the Communications department to keep the Regulatory Affairs content on the ISPE website current.
- Locate documents released for public comment on regulatory agency websites.
- Provide administrative support to ISPE’s regulatory commenting process, including compilation of comments and communication with commenting teams.
- Provide administrative support to committees as assigned: take and distribute minutes, conduct Doodle polls, schedule meetings using Outlook and conference line service, open calls when needed, maintain committee lists in iMIS, synch Outlook distributions lists with iMIS.
- Other duties as assigned.
- Provide back-up administrative/office support to Bethesda Office Manager, as needed.
Education and work experience:
- Bachelor’s degree in political science or related field; 2-3 years of experience in an Administrator role that required writing/technical writing. Regulatory or government affairs experience preferred; pharmaceutical experience a plus but not required.
Skills and Knowledge:
- Intermediate skill in Microsoft Office products.
- Ability to work independently with minimum supervision and manage multiple concurrent projects with attention to detail.
- Must have excellent writing skills.
- Must be able to discern sensitive issues and handle them in complete confidence.
- Must be able to work well with a variety of people.
- Able to plan, organize and carry out work from a variety of sources to meet deadlines and achieve objectives.