ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Edit, format, and prepare (or assist in preparing) documents produced by the statistical and scientific teams based on approved templates and following the internal style guide and standards.
- Start a file using the appropriate ERT template.
- Incorporate key information from the appropriate source documents (eg, study protocol, investigator’s brochure, scope of work, and internal study plan documents).
- Insert tables and figures into a document shell, format according to ERT style, and insert hyperlinks.
- Circulate documents internally for review.
- Edit, format, check hyperlinks, and perform medical writing quality control checks of documents prior to release to the client.
- Develop the expertise required to interpret results and write text for documents (eg, results sections, discussion, and summary of reports).
- Participate in the scheduling process and support the team in meeting deadlines.
- Participate in document revision cycles and comment resolution processes.
- Perform formatting and editing revisions, as requested by the client
- Create clean versions of documents for subsequent revision cycles and final versions for signatures.
- Develop expertise in Microsoft Word advanced features (eg, styles, fields, and macros) and the ability to troubleshoot formatting problems.
OTHER DUTIES AND RESPONSIBILITIES:
- Understand ICH/FDA/EMA regulations in regards to clinical trial reporting.
- Provide support internally for editing and formatting tasks as needed (eg, fixing formatting problems in Word documents for other team members, editing or formatting SOP/SWI documents, editing or formatting slide presentations).
- Contribute to a respectful and inclusive work environment and exhibit ERT behaviors and communication expectations.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.