• Provide writing and editorial support for a government agency's program operation, monitoring, compliance, and reporting activities • Author and disseminate content related to policy statements, guidance, and memoranda • Conduct quality assurance reviews of correspondence, reports, presentations, and other written communications • Drafts new and reviews existing content including reports, letters, memoranda, presentations, and webpages • Contributes to the development of monitoring and compliance-oriented reports • Ensures adherence to agency standards regarding quality, format, and style • Assists with dissemination of information using various online platforms • Reviews and remediates written content for accessibility standards • Manages multiple writing and review assignments concurrently • Participates in meetings as required and assists with additional duties as assigned

• Create, edit, and maintain technical documentation using Markdown and reStructuredText • Develop and improve product documentation, including installation and deployment guides, configuration and usage documentation, API references and examples, troubleshooting and best-practices guides • Write clear, concise, and accurate documentation for both technical and non-technical audiences • Manage documentation repositories on GitHub, including version control, reviews, and contributions • Collaborate with engineers to document new features, APIs, and architectural changes • Ensure documentation aligns with product releases and open-source standards • Review and accept documentation contributions from the community • Work closely with Engineering, Product, and Customer Success teams to gather technical insights • Participate in design discussions to understand technical workflows and system behavior • Validate documentation by testing features, APIs, and workflows hands-on

• 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