• 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.

• Create "High-Floor" Content: Write highly technical blog posts, landing pages, email sequences, and ads that respect the reader's intelligence, featuring code, architectural diagrams, and honest discussions of production tradeoffs • Drive the Narrative: Translate complex distributed systems concepts like Durable Execution, idempotency, and compensation logic into opinionated content that speaks peer-to-peer with engineers • Customer Storytelling: Produce developer-focused case studies and customer co-marketing content that highlight real-world use cases • Collaborate with SMEs: Work with engineering subject matter experts and customers to deeply understand systems, workflows, and design decisions • Own the Content Lifecycle: Take content from research and interviews through drafting, iteration, and publication • Develop Your Craft: Refine your technical writing skills and deepen your understanding of distributed systems concepts

Role Description Join Excelya as a Senior CMC Regulatory Technical Writer, where Audacity, Care, and Energy define who we are and how we work. You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements. This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding. Main Responsibilities: - 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 Qualifications - Minimum 10 years of experience in CMC within the pharmaceutical industry and CMC regulatory technical writing - Excellent writing, editing, and organizational skills - Strong understanding of regulatory requirements and guidelines (ICH, FDA, EMA, etc.) - Ability to work collaboratively in a fast-paced environment - Degree in Pharmacy or a relevant scientific field (Chemistry, Biology, or equivalent) - Fluent in written and spoken English Benefits - Excelling with care means benefiting from an environment that values your natural talents - Pushes boundaries with audacity - Nurtures your potential, allowing you to contribute fully to our shared mission