Job Description
When our values align, there's no limit to what we can achieve.
Document Specialist I
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.
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