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Accentuate Staffing is recruiting for a Regulatory Document Formatter in a contract position with major pharmaceutical company in RTP, NC.  This position will be from now until December 31st.  This position will be Formatting documents (primarily MS Word and Adobe PDF) using styles, templates, tables, sections, graphics and other features to ensure compliance with FDA, EMA, ICH specifications and guidelines. The Document Formatter will support global Regulatory submissions. The ideal candidate will be responsible for ensuring formatting of all documents included in Regulatory submissions meet the requirements set forth in Agency guidelines and regulations.

Responsibilities:

• Format documents in Microsoft Word and Adobe Acrobat according to internal SOPs and FDA, EMA, and ICH specifications and guidance
• Format documents using submission template to ensure formatting consistency
• Generate and format Table of Contents, Table of Tables, Table of Figures, etc.
• Create hyperlinks
• Format tables
• Convert documents to PDF and edit native PDF files according to internal SOPs and FDA, EMA, and ICH specifications and guidance to prepare for submission
Investigate user problems and needs, identify source, and determine
• possible solutions for MS Office and Adobe PDF issues
• Maintain document version control, tracking changes and layout of document in template form

Requirements:

• Advanced knowledge of Microsoft Word, including ability to troubleshoot issues
• Advanced knowledge of Adobe Acrobat Professional, including ability to troubleshoot issues
• Must be proficient using other Microsoft Office Applications such as MS Excel and MS PowerPoint
• Minimum 3 years of experience in a document production environment requiring skills in document formatting
• Experience with EDMS preferred
• Flexibility to work additional hours (evening and weekend) as required by workload.
• Ability to prioritize work to balance multiple projects and meet tight deadlines.
• Ability to pay attention to detail and work independently with minimal supervision
• Bachelor’s degree required; equivalent combination of relevant education and/or experience may be substituted