• Provides support in the preparation and/or maintenance of systems documentation, procedures and methods, and maintenance of documentation library as required. • Revises or writes material that is mostly standardized for reports, manuals, briefs, proposals, instruction books, catalogs, and related technical and administrative publications concerned with work methods and procedures, and installation, operation, and maintenance of equipment. • Receives assignment and technical information from a supervisor or senior writer, provided notes or manuals containing operating procedures and details, and may observe production, developmental or experimental activities to expand or verify the provided operating procedures and details. • Accesses information from blueprints, sketches, drawings, parts lists, specifications, mockups, and product samples to integrate and delineate technology, operating procedure, and production sequence and detail. • Organizes material and completes writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology, may maintain records and files of work and revisions, select photographs, drawings, sketches, diagrams, and charts to illustrate material, assist in laying out material for publication arrange for typing, duplication and distribution of material, and may specialize in writing material regarding work methods and procedures.

• Author, review, and finalize high-quality CMC sections (Module 2.3 and Module 3) for Phase 3 and Marketing Authorization Applications • Prepare briefing documents and responses to Health Authority questions as required • Collaborate with CMC technical teams (process development, formulation, analytical, manufacturing) to collect and interpret data • Ensure alignment of all documentation with global regulatory requirements (ICH, FDA, EMA) • Develop, maintain, and continuously improve CMC regulatory dossier templates in line with evolving guidelines • Manage submission workflows within the electronic document management system (eCTD environment) • Ensure consistency, accuracy, and scientific integrity of all regulatory narratives • Manage timelines across multiple projects and proactively communicate risks • Provide guidance and support to internal stakeholders when needed

• Create, update, and maintain a comprehensive library of software documentation, including system design and requirements, user guides, internal process documents, API references, release notes, and technical specifications. • Collaborate closely with software engineers, product managers, architects, and QA teams to gather, understand, and accurately document technical requirements, designs, and implementation details. • Write clear, concise, and well-structured technical documents tailored to different audiences (developers, testers, stakeholders, end-users). • Ensure consistency, version control, and traceability across all documentation artifacts. • Apply best practices in technical writing, including the use of templates, style guides, and structured authoring techniques. • Format, edit, proofread, and finalize documents using advanced features of Microsoft Word (styles, templates, tables, headers/footers, track changes, references, TOC automation, etc.). • Manage document repositories, implement version control processes, and ensure documentation remains current throughout the software development lifecycle. • Participate in peer reviews, gather feedback, and continuously improve documentation quality and usability. • Assist in creating visual aids (diagrams, tables, flowcharts) to enhance understanding when appropriate.

• Develop, edit, and format technical documents by incorporating technical and performance data. • Ensure documents are consistent with organizational and marketing standards. • Build, maintain, and manage a comprehensive library of technical documents. • Develop and maintain a cross-referencing and cataloging system for easy document retrieval. • Collect, organize, and update supporting attachments for technical documents. • Ensure all technical documents meet internal quality standards and external compliance requirements. • Review and update technical documents on a scheduled basis to maintain accuracy and relevancy. • Work closely with the Quality Assurance Department to ensure documentation supports quality initiatives. • Collaborate with engineers, quality assurance, and marketing teams to ensure alignment of documentation with product performance and marketing messages. • Provide document control support for other teams as needed.