iMPact Business Group
Job Description
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. Job Requirements
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.
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. Job Requirements
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.