Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a R&D Technical Writer for a 12-month+ contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment. 

Position Description (Principal Duties and Responsibilities)

• Assisting in the timely development and completion of clinical reports, summary documents, package inserts, and other regulatory documents.
• Overseeing the electronic regulatory submission process and ensuring compliance with submission standards.
• Overseeing and providing recommendations for the development of formats and guidelines for documentation.
• Providing guidance and direction for the completion and development of clinical and pre-clinical documents.
• Ensuring effective planning and management of timelines for all aspects of technical document development.
• Focusing on the remediation of IFUs to align with the latest regulations and standards, which may require converting IFUs from Adobe source files to DITA XML within a content management platform.
• Managing label requests and coordinating with the labeling design team.
• Leading change control activities in the Product Lifecycle Management (PLM) system.

Requirements

• Degree required.
• A minimum of 4 years of experience in technical writing or related fields.
• 2 years of experience working with Oracle Applications at an intermediate level.
• Proficiency in Adobe software at an intermediate level.
• Hands-on experience with XML at an intermediate level.
• Strong technical writing skills with at least 2 years of experience.
• Experience using content management systems at an intermediate level, with at least 2 years of experience.
• Experience with Arbortext and Windchill is a plus.
• Familiarity with Oracle Agile is preferred.