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Document Archivist (Part-Time Contractor)

Company: Mitsubishi Tanabe Pharma
Location: Jersey City
Posted on: June 6, 2021

Job Description:

Document Archivist (P/T Contractor) – Join our Dynamic Team!

 

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

 

MTDA is rapidly expanding our operation across all functional areas to assist in the research and development of new products for the U.S. market.

 

The Document Archivist will assume setting up an archival system and exercising primary control for the storage, retrieval, retention and destruction of controlled documentation and records pertaining to clinical development activities managed by MTDA upon request and in compliance with internal policies/procedures and regulatory requirements. This is a part-time contract role.


  • Recall and re-catalog existing archived information (approximately 3000 boxes) to improve the organization of archived records.
  • Sort through filing cabinets to organize, catalog and archive hard-copy study data and/or other controlled data records.
  • Provide oversight of Archival External Service Providers and coordinate off-site archival activities including interaction with off-site archive facilities for data storage and retrieval.
  • Monitor retention periods for controlled documentation.
  • Support the maintenance of an MTDA archival budget (e.g.: assess boxes under MTDA budget to determine a reasonable estimate of archive facilities storage costs).
  • Support audit/inspection activities by recalling and providing requested archived information.
  • Oversee disaster recovery plans for ensuring back-up of records in archived boxes.
  • Utilize storage software and applications for electronic filing.

  • BS/BA degree in a business or technical discipline or equivalent experience.
  • Experience with cataloging, scanning, filing, storage, and retrieval of documents.
  • Understanding of the drug development process and health authority regulations (21CFR, GCP and ICH).
  • Appreciation for the importance of the documentation generated from clinical development processes and the need for their storage and retrieval.
  • Able to work autonomously and to prioritize daily tasks and responsibilities effectively.
  • Strong verbal communication and interpersonal skills; able to work effectively in a multi-cultural, multi-lingual environment.
  • Highly analytical with a strong attention to detail.
  • Required to travel on occasion (not to exceed 5%) to US-based external service providers.

 

Keywords: Mitsubishi Tanabe Pharma, Jersey City , Document Archivist (Part-Time Contractor), Other , Jersey City, New Jersey

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