Project Assistant (REF8602L)

Job Description

Individual proficient in Word and PowerPoint with the ability to learn advanced features required to support scientific consulting staff for the Regulatory Affairs (RA) Consulting group.

This individual will be trained to become an integral part of the Project Support Team while handling the day-to-day/ongoing non-billable tasks required to maintain operational efficiency within the RA Group. S/he works closely with Project Administrator(s), Director, Administrative Services and Project Managers to ensure tasks are understood and completed on a timely basis. (Note:A Project Manager is the person dedicated to specific project(s) as the point person for client interactions and manages the internal/external flow of work and can be any level: Consultants, Sr. Consultant, Directors, V.P., Executive V.P. or the CEO).

• Handles the ordering and file management of articles, books, FOIA requests, ISO standards, etc. which are requested by consulting staff as needed for their projects
  • Provides monthly summary to Accounting Dept. with details for client/project billing
• Data entry of project related activities
• Maintenance of submission detail log
• Document management – on the job training provided as part of the Project.Support team:
  • Create review tables to organize milestone applications tracking the flow and status of documents in review by Project.Support
  • Organization of supporting documentation – working with Adobe Acrobat tools to finalize and produce submission-ready pdf files
  • Proofreads and formats Deliverables (client reports and FDA submissions)
• Checks for updates to FDA guidance documents and forms; manages the filing/uploading of new versions in One Notes and network folders
• Client Meetings: Arrangements for hotel rooms; conference rooms; travel; catering; transportation; meeting set-up/clean-up and ad hoc (on demand) tasks during meeting
• Training on Sales Force/Business Development processes in order to serve as backup support to BD Coordinator as needed

• Maintains log for credit card charges and e-filing of receipts for projects/admin./marketing expenses incurred (using corporate credit card); coordinates with Accounting for appropriate coding to projects or non-billable projects/tasks
• Special ad hoc projects/assignments as needed
• Prepare and submit expense reports for EVP, VPs and consulting team members

Qualifications

• Entry level position with Associates Degree or similar amount of administrative experience (i.e.,Document Specialist, Regulatory Department for Pharmaceutical/Biotech firm; healthcare industry; actual experience working on FDA submissions is ideal)
• Strong writing, editing, and proofreading experience (must enjoy reading)
• Proficiency in Microsoft Office with strong capabilities in Word, solid PowerPoint and Excel skills
• Able to take direction from other members of Project.Support team and can also work autonomously to complete tasks
• Organized and detail-oriented with excellent time management skills
• Must be able to shift priorities and manage the demands of varying project deadlines
• Team-Player: Must be willing to pitch in when needed; even if something is out of scope of normal duties.

Additional Information

All candidates must be legally eligible to work in the United States.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.