Primary Role: The Medical Editor will be required to edit clinical documents for regulatory submissions. The editor will ensure that the documents are grammatically correct, logical, accurate, and in the correct format required for submission/publication.
- Perform detailed quality review of documents, including content QC, technical QC, copyediting, formatting, and compliance with the Shire HGT Style and AMA style guide
- Assist the writer with the creation/production of documents according to ICH Guidelines and company-defined templates
- Obtain copies of publications referenced in documents for appendices
- Assist the writer with the review and approval process, including compilation of reviewers comments as needed
- Assist as required during QA auditing process Provide Shire team members with mentoring and training for document authoring standards, QC processes, and overall communication with Shire Medical Writers.