• 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.

• Maintain and expand Hauler Hero’s Help Center content in Intercom to ensure articles and videos are accurate, complete, and customer-friendly. • Develop customer-facing product training materials including video tutorials, walkthroughs, and feature overviews using Loom. • Create clear, easy-to-follow documentation that helps customers troubleshoot, adopt new features, and get value from the platform faster. • Use Figma to create visuals, annotated screenshots, and diagrams that enhance written documentation and video content. • Translate technical details from Product and Engineering into customer-ready materials and release notes. • Partner with Customer Success to identify knowledge gaps and proactively create resources to address them. • Partner with Implementation to ensure Implementation Associates have materials to provide customers in onboarding high-quality training materials specific to their use cases. • Work with QA and Product to document new releases, validation steps, and test outcomes. • Organize and manage internal documentation in Notion so teams have access to consistent, up-to-date information. • Monitor feedback from customers and internal teams to continuously improve clarity, tone, and coverage of documentation. • Identify opportunities to leverage AI for scaling customer education, documentation updates, or translation support while ensuring accuracy and brand alignment. • Occasionally assist with customer support coverage during busy periods and to ensure first-hand understanding of customer needs and pain points.