Job Description

When our values align, there's no limit to what we can achieve.
 

Parexel FSP is seeking a Document Specialist for an exciting opportunity in Canada. This role requires strong experience with publishing software and preferably ISI toolbox experience.

Key Accountabilities:

Compilation and publishing

  • Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, with support of the project lead and lead medical writer. Work with internal or external Clinical and/or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines.
  • Understands global regulatory submission formats, industry standards, and guidelines, and publishing best practices
  • Use departmental publishing software to produce electronic deliverables to ensure insertion of navigability features, and accurate intra-document hyperlinking, according to SO...

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