Technical Writer (Medical Device Product Labeling, Project Coordination)

Responsibilities

• Develops, revises, and reviews product package inserts and user's manuals to ensure compliance/conformity with existing Corporate, Regulatory and Global (ISO, PAL, etc.) guidelines.
• Works with internal teams (R&D, Marketing, Quality, Medical, Regulatory, and Plant production teams) to obtain an in-depth understanding of the product and the documentation requirements.
• Writes and/or prepares technical software documentation.
• Studies and reviews manufacturers' data, drawings, parts lists, and prototypes to delineate technology, operating procedures, and specific logistics of operation.
• Collaborates the development or revision of product documentation/digital content to determine specifications for: type style, font size, clarity and conformity of wording, formatting, topic-based order, and printing deliverables.
• Works with Label Control, Incoming Inspection, Operations, and Quality to resolve issues regarding technical documentation and to develop procedures geared toward minimizing and eliminating recalls related to technical information.
• Creates and maintains multiple information architecture outputs.
• Analyses existing and potential content, focusing on reuse and single-sourcing opportunities.
• Develops and reviews vendor specifications for technical documentation, and develops and maintains graphic standards for manuals and digital content.
• Participates in the GPDS product development process.
• Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business unit and plant projects to meet established goals.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements; participates as required in training on regulatory issues affecting own area of work; brings regulatory compliance questions/issues to the attention of management.

Qualifications

• Bachelor's degree in English or related field with a minimum of five years of experience in technical writing and a minimum of two years of experience managing digital content projects; or equivalent combination of related education and experience.
• Ability to lead and participate in group projects, act as a team leader, develop project timelines, communicate effectively, and implement projects.
• Ability to handle multiple projects with excellent follow-up skills.
• Detail-oriented and have the ability to work under deadline pressure; must be able to deal with unresolved situations, frequent changes, delays, or unexpected events.
• Ability to perform spreadsheet and database maintenance for reporting the status of projects to management.
• Strong interpersonal and oral communication skills.
• Demonstrated proficiency in technical writing and editing for print and digital content.
• Functional knowledge of Microsoft Office Suite (MS Word, MS Excel).
• Demonstrated proficiency in DTP software applications (Adobe InDesign, Adobe FrameMaker, Adobe Illustrator).
• Knowledge of digital content software applications such as MadCap Flare or RoboHelp is required.
• Able to travel domestically and internationally up to 10%.