Clinical Document Specialist, Takeda Pharmaceuticals, Cambridge, MA

Posted May 9, 2019

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 [email protected]