 Roles & Responsibilities - Support writing teams in building and publishing electronic documents for submissions in Common Technical Document format (eCTD)
- Document management including electronic filing and archiving
- Communication with clients as directed
- Act as resource for medical writers regarding client specific style guides, document systems, document templates and toolbars
- Provides training to medical writers on use of toolbars as necessary
Formatting Specialist - Format documents as per client templates or in-house templates including review of references, header/footer, TOC, page layout , page size, etc.
- Create documents as per the requirement of medical writers
- Provide support in word processing software to medical writers, programmers, biostatisticians (MS Word, MS PowerPoint, MS Excel, MS Publisher, Adobe Acrobat Professional)
- Create/Modify all MMS Templates
- Support Document Management Systems
- Make PDF containing bookmarks to organize all TLGs provided in various formats from the client. This allows for easy reading and retrieval and eliminates excess printing
- Develop a series of formatting and template training sessions and provide instruction for Medical Writers
- Perform FDR per Order Fulfillment Procedure on applicable documents for delivery to client
|
No comments:
Post a Comment