Technical Writer

Job Description

Work collaboratively with regulatory, quality, package engineering, document control, and product development team(s) to develop new product labelling (Label/IFU/User documentations) Understanding country specific regulatory needs Labelling design as per regulatory & business requirements Review of all labelling based on the various domestic and international requirements including product labels, instructions for use, e-labelling, website, advertising, and promotional materials Understands impact(s) of labelling design and development as part of overall product and packaging development. Effectively engages with the project team and seeks out support when appropriate. Manages change controls for labelling release and updates. Assist in development of labelling processes and policies. Standardize labelling printing technology software and labelling formatting/templates across sites; as well as labelling content development. Fosters a collaborative environment and gains support and cooperation for ideas proposals projects and solutions to accomplish goals. Continuously builds knowledge keeping up to date on the technical or procedural aspects of labelling and labelling regulations. Utilizes good documentation practices (i.e. revision control red lining Agile release) All other essential related duties as required. Experienced with label/graphic design tools - Codesoft, Adobe Illustrator, InDesign preferred Qualification : Education - B.E/B.Tech 4 to 8 years of industrial experience in Pharma or medical device environment Relevant labelling experience, preferably within a regulated environment an advantage but not essential Knowledge of RA/QA and FDA, EU MDR requirements for packaging and labelling Knowledge of ISO 7001, ISO 15223 Strong organizational and project coordination skills PC literate and strong knowledge of Microsoft office tools are essential