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Nonclinical Archiving Intern, Takeda Pharmaceuticals, (Cambridge, MA)

Description

The Nonclinical Writing (NCW) Document Lifecycle Management (DLCM) team is responsible for the initiation, management, and archiving (electronic and hard copy) of submission-related nonclinical documentation. This includes study and report number assignment, document process development and implementation, and facilitation of document workflows, maintaining regulatory requirements across all aspects. As part of this responsibility, the NCW DLCM team oversees the Nonclinical Research Archive, which will be the focal point of this internship.

Takeda’s Nonclinical Writing team is seeking a full-time paid intern to assist with completing the preservation and organization goals in the Nonclinical Research Archive at the Cambridge, MA location for 12 weeks over the summer.

Responsibilities

As a Nonclinical Archiving Intern, reporting to an NCW DLCM Manager and working directly with the NCW DLCM Team, you will have the opportunity to

  • Assist with ongoing archival activities and projects
    • Nonclinical Research Archive indexing and reconciliation
    • Supporting an ongoing eFile preservation project
    • Electronic archiving in the EDMS
  • Manage nonclinical documentation throughout its lifecycle
    • Study & Report Number Assignment
    • Protocol & Report Template Assignment
    • Document workflow management
  • Additional duties may be assigned as necessary.

Internship Development Opportunities:

  • Learn how to manage a corporate archive in a highly regulated environment
  • Learn about regulatory requirements and industry standards for nonclinical submission documents
  • Learn about the pharmaceutical industry as a whole, and gain valuable experience

Qualifications

  • This position will be Hybrid (2-3 days/week in office) out of the Cambridge location
  • Must be pursuing a Bachelors or Masters Degree in a relevant field such as Library Science or Regulatory Affairs.
  • Basic computer skills including MS Office (PowerPoint, Words, Excel)
  • Internet skills including use of email, group messaging, and information gathering
  • Highly reliable and a strong team player
  • Attention to detail is critical
  • Strong verbal and written communication skills

Elligibility

  • Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship 
  • Must be currently enrolled in a degree program graduating December 2026 or later 
  • The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)  
  • The intern must be able to commit to one of these time frames  
  • Able to work full time 40 hours a week during internship dates  
  • Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program 

Hours and Compensation

Schedule: 40 hours per week for 10-12 weeks, hybrid of remote and on-site.

Compensation: $21.00 – $46.00

The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate’s school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.