Job Description

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 SOP/client/regulatory requirements
  • Perform MS Word formatting of clinical documents according to SOP/client/regulatory requirements. Insert tables if requested.
  • Coordinate production and distribution of draft and final documents to project team and client. Organize and track delivery of al...

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