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Clinical Document Specialist, Takeda Pharmaceuticals, Cambridge, MA

Working member of an audit inspection-ready R&D paper and electronic Archives, responsibilities include: 

  • Insure the timely return/closure of records from authors 
  • Manage the recall of archived records for legal and regulatory support
  • Support the integration of records acquired via mergers and acquisitions
  • Monitor team inbox regularly for questions and requests on records
  • Help to transition the use of Service Now, OpenLabs and SharePoint request management which includes, but is not limited to:
    • Support Training for new systems use and create quick use guides
    • Trouble shooting request in for users in new system
  • Support document Issuance: Issuing records to users in a timely manner including Reports, Protocols, Paper Notebooks, Databooks, Binders, etc. 

20% Additional Administrative Responsibilities:

  • Revising, writing, reviewing and initiating new SOPs as needed
  • Maintain contracts and relationships with vendors and third parties
  • Route POs, invoices, and vendor information in SAP, as well as recommend cost-effective improvement strategies
  • Conduct quarterly electronic laboratory and paper notebook training

Education and Experience Requirements

  • BS or BA required (or higher)
  • Experience as an archivist or documentation specialist, preferably in a biotech, pharmaceutical, or healthcare environment, with 1 years of experience BS or a BA
  • Experience working at a CRO, or in a Lab Science is a plus
  • CRM certification or MSLS/MSLIS is desirable
  • Experience with SharePoint, and Inventory/Content management systems such as (OmniRIM, FileBridge,etc.) preferred

 

Please send all resumes to alyssa.wyson@randstadusa.com

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