Document Specialist

  • location: Cambridge, MA
  • type: Contract
  • salary: $19.50 - $21.18 per hour
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job description

Document Specialist

Job Title: Documentation Associate Nonclinical Writing and Documentation

Position Description

  • Accountabilities Formatting and document management activities for nonclinical studies and summary sections, and electronic archiving. Template maintenance.
  • Supports drug development through production, monitoring and archiving of nonclinical protocols, reports and documents for regulatory filings. Primary responsibilities include: coordinating documentation for worldwide regulatory submissions; report level publishing, eCTD hyperlinking and QC checks, oversight and /or technical support of nonclinical document preparation including electronic submissions.
Position Responsibilities

  • GLP nonclinical study protocol and report document life cycle coordination and/or preparation.
  • Regulatory submission coordination
  • General quality compliance.
Position Requirements

  • AS/BS (preferably in technology, sciences or information-related field) recommended. Minimum 2 years experience in a regulated environment with hands-on experience in document management, submission and/or large-volume document preparation. A team player with excellent communication skills and advanced computer literacy is required. Experience in biological research and development is preferred. Proven ability to work independently and effectively handle multiple projects.
  • Strong knowledge of word processing applications, database structure, multiple computer applications: electronic document management systems (Documentum or similar applications), EndNote, Oracle, SharePoint.
  • Ability to work on several documents at the same time, high attention to detail and accuracy, ability to consistently hit deadlines, excellent written and oral communication skills.
  • High level of competency required in teamwork for departmental and cross-functional project teams.
  • Fundamental knowledge of worldwide regulatory submissions guidances a plus.

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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