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.
Ascend PM are hiring a Technical Writer to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more
Overview:
An exciting opportunity has opened within the Manufacturing Support team for a Technical Writer. In this role, you will be responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.
Key Responsibilities:
- Develop/ Update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner
- Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs
- Involvement in projects as part of continuous process improvement and / or troubleshooting
- Ownership and management of change controls as required
- Issuance and updates of paper batch records in line with production schedule
- Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS
- Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
- Perform document trending upon project completion to identify keys issues/mistakes in document processing.
- Support data verification of Operations owned protocols reports and risk assessments
- Support the production support team in reducing document turnaround times
- Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs
- Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs
- Ensure Non-conformance are triage within the established goal and serve as a deviation owner for minor deviations.
- Own corrective /preventative actions and effectiveness verification.
- Support execution of C&Q, characterisation, functional testing protocols as required by project. NOTE: This may require flexible working hours.
Experience & Qualifications:
- Bachelor’s degree in a Science or Engineering discipline.
- 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage
