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Technical Writer III
Ref No.: 18-01407
Location: Monroeville, Pennsylvania
Start Date / End Date: 09/03/2018 to 12/31/2018
Title                           :    Technical Writer / Editor 
Work Location       :     Monroeville, PA
Work Hours            :   8:00 - 5:00
Duration                  :   3 months

Education B.S. or B.A in English, Writing, Computer Science, I.T. or equivalent 
Experience 5 – 7 Years of Experience. Duties and tasks reflect variety and complexity. 
Demonstratable excellence in command of the English Language required. 
Mastery of page layout, word processing, and computer-generated illustrating using the following

1. In-Design 
2. Illustrator 
3. RoboHelp 
4. SnagIt 
Key Areas of Responsibility Business Support – Technical Writing Support for New Product Development and Sustaining efforts in both the domestic and international markets for assigned products. Provide direct project support for labeling in mature and emerging markets. 

Quality Culture/Process Improvement – Identify areas for improvement for efficiency and compliance in the internal processes, work instructions, and forms and lead Hoshin or Improvement teams to affect change. 

Training – Maintain technical proficiency in core job functions including all applicable QSPs, WI, Forms, Client’s training, and regulatory body requirements. Acts as a Mentor/Trainer for Associate Technical Writers 

Regulatory and Writing Proficiency – Work with assigned Regulatory Mentor(s) to maintain a working understanding of the interpretation of domestic and foreign regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned products, with a primary focus on Labeling for the mature markets: USA, Canada, EU, Japan, and Australia, and a secondary focus on Emerging Markets: Brazil, China, LATAM, AP, Russia, India. 
Job Function Work independently on TW duties, processes and roles outlined below: 
1. Sits on New Product Development Team for assigned products and provides labeling analysis on the Product Development Plan 

2. Creation and execution of Labeling Plans for assigned products in the Domestic, Mature, and Emerging Markets, including released Labeling lists to support regulatory restrictions. 
3. Creation, revision, review, and approval of Labeling (User Manuals, Provider Manuals, Quick Start Guides, Product Labels, Packaging Labels, Help Files, etc.) 
4. Supports Internal and External Quality Audits 
5. Actively supports CAPA’s as they apply to Labeling 
6. Leads Labeling Process Improvement efforts / Hoshins 
7. Partners with Translation Coordinator(s) throughout the execution of the associated Labeling plans. 
8. Interfaces with Business Unit functions as needed to resolve labeling concerns 
9. Tracks the impact of pending domestic and global regulatory changes on Labeling 
10. Conducts department training on Labeling requirements 
11. Maintains proficiency in domestic and foreign regulations and standards, with a focus on Labeling for assigned products and global impact but a regional focus on the US (FDA), EU (MDD), CA (Health Canada), BZ, JPN, and AU (TGA).