Ascend PM are hiring a Technical Writer to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more
Overview:
An experienced technical writer with a track record of developing user-friendly, comprehensive documentation. You will work within the Global Device Engineering department supporting the creation of medical device operator manuals and technical documents. Deliver content to support the delivery of state-of-the-art software solutions & GUI’s.
Job Responsibilities:
• Develop and edit medical device labelling content (e.g., user manual text and design, device labels) that is easy-to-read and understand by end users.
• Collaborate closely within a cross-functional team (with Regulatory Labelling, Quality, Clinical, Human Factors, Commercial, Engineering, Regulatory etc.) to optimize medical device labelling clarity and completeness.
• Translate technical jargon into user-friendly language to ensure documentation is accessible to a diverse audience.
• Extract relevant information from complex engineering documentation for use in clinical instructions, including working autonomously with limited direction.
• Understand regulatory requirements for medical device labelling, and develop labelling to meet these.
• Research new operator manuals, modifications to existing manuals, technical bulletins and other written material. Edit documentation written by others.
• Develop labeling for all medical devices and accessories.
• Stay up to date with product updates/changes, collaborating with development teams to ensure accurate and timely documentation
• Work within the defined company processes to ensure compliance.
• Conduct reviews and updates of existing documentation to reflect changes in software or hardware configurations.
• Support external language translations.
Job Requirements:
• Five (5) plus years Technical Writing experience.
• Excellent writing and editing skills, with a keen eye for detail and clarity.
• Demonstrated experience of producing medical device labelling content compliant with US and/or EU regulations and standards.
• Ideally experience using common technical writing tools (e.g., Adobe Creative Suite and MS Word, Excel, PowerPoint etc.).
• Knowledge of documentation quality management systems is desirable. Mastercontrol experience is an advantage.
• Excellent problem-solving methodology, using industry-accepted concepts and tools to solve complex problems in creative and effective ways.
• Comfort working in fast-paced, results-driven environments with tight timelines and frequent changes.