Technical Writer

• 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