Sr. Technical Writer-Pa

Macropace Technologies Monroeville , PA 15146

Posted 6 days ago


Job Description:
Demons ratable excellence in command of the English Language required. Mastery of page layout, word processing, and computer-generated illustrating using the following tools:

  • 1.
  • In-Design
  • 2.
  • Illustrator
  • 3.
  • RoboHelp
  • 4.
  • SnagIt


    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,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:
  • Sits on New Product Development Team for assigned products and provides labeling analysis on the Product Development Plan
  • Creation and execution of Labeling Plans for assigned products in the Domestic, Mature, and Emerging Markets, including released Labeling lists to support regulatory restrictions.
  • Creation, revision, review, and approval of Labeling (User Manuals, Provider Manuals, Quick Start Guides, Product Labels, Packaging Labels, Help Files, etc.)
  • Supports Internal and External Quality Audit,Actively supports CAPAs as they apply to Labeling
  • Leads Labeling Process Improvement efforts / Hoshins
  • Partners with Translation Coordinator(s) throughout the execution of the associated Labeling plans.
  • Interfaces with Business Unit functions as needed to resolve labeling concerns
  • Tracks the impact of pending domestic and global regulatory changes on Labeling
  • Conducts department training on Labeling requirements
  • 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).

    Education B.S. or B.A in English, Writing, Computer Science, I.T. or equivalent.

    Thanks,

    Macropace.

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