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Intern, Shire, Lexington, MA

Summary:

  • 32-40 hours per week, team is willing to be flexible for a student’s schedule
  • Willing to take a graduating student
  • 6 month term, paid internship
  • For more information please contact: Laura Ganio <[email protected]>

The R&D Scientific Documentation group is offering a 6 month internship to a detailed oriented graduate student to assist the consolidation and management of study records (Good Laboratory Practices and Good Clinical Practices) to a third party archive vendor. Efforts will focus on chain of custody (provenance) documentation, inventory management data entry, record retention scheduling and dispositions, as well as research in inventory management system to support regulatory filings.

Daily activities should include:

  • Interacting with third vendors (Contract Research Organizations (CRO)) to confirm study information
  • Guide the detailing of record disposition centralize archive or discard
  • Locating and index study information for NCD requests and submission
  • Supporting the logistics to centralize off site material to Shire preferred vendors
  • Data entry in the Preclinical Information Management system (PIMS) to: updating and clean up for legacy study information and archive location, updating vendor relationships and information

Required Skills:

  • Attention to detail and ability to take responsibility for a high volume of multiple tasks is required.
  • Ability to manage competing and reprioritizing task
  • Excellent verbal and written communication
  • Customer service experience, is a plus
  • Experience with SharePoint and Office 365 is preferred
  • Experience with Oracle and financial systems is preferred
  • Documentation, archive or laboratory science experience is a plus
  • Enrolled in a master’s degree program for archiving or regulatory management, preferred

Technical Skills:

  • MS Office suite or Office365 (SharePoint, Word, Excel, Outlook, etc.) specifically advanced Excel skills
  • Work with off-site storage providers (EPL archives or Biostorage)
  • Information literacy, key word searching, and data mining

Other Requirements:

  • Lifting (15-30 lbs.) may be required: shelving materials involves reaching and bending and occasionally utilizing step stool or short ladder for higher shelves.