The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Melbourne, a leading biotech hub in Australia. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global professionals committed to making a meaningful impact. At Moderna, you will play a pivotal role in transforming complex clinical data into transparent, scientifically rigorous and regulatory‑compliant documentation that advances our clinical development programs. Reporting to the Senior Director of Medical Writing Delivery and Excellence, you will drive the planning, coordination, authoring and delivery of high‑quality clinical and regulatory documents while collaborating with cross‑functional teams across time zones. Through your technical expertise, strategic judgment and commitment to operational excellence, you will help strengthen our medical writing capabilities and contribute directly to the advancement of innovative mRNA medicines for patients.

Here’s What You’ll Do:

- Lead clinical and regulatory medical writing activities: Apply advanced conceptual and practical knowledge of medical writing principles, scientific communication and regulatory documentation to plan, develop, author, review and deliver accurate, scientifically robust clinical and regulatory documents supporting Moderna's clinical development programs, from initial planning through final draft delivery.
- Drive strategic document planning and execution: Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions, establishing clear deliverables,



timelines, dependencies and review milestones. Coordinate medical writing activities to ensure timely, efficient execution while maintaining scientific integrity and alignment with broader clinical development objectives.
- Deliver operational excellence through project management: Independently oversee multiple medical writing deliverables, proactively identifying risks, resolving competing priorities and ensuring deadlines are achieved. Adapt functional plans and priorities to meet short‑term operational objectives while maintaining visibility of program‑level requirements and longer‑term development goals.
- Strengthen cross‑functional scientific collaboration: Partner closely with clinical development, regulatory and other relevant cross‑functional stakeholders to ensure scientific consistency, accuracy and integration across clinical and regulatory documents. Communicate complex scientific information effectively, explain difficult or sensitive issues and build consensus when stakeholders hold different perspectives.
- Enable seamless global delivery and regional coordination: Collaborate closely with the Medical Writing Delivery and Excellence team to support effective “follow‑the‑sun” working practices, including coordinated time‑zone hand‑offs,



continuity of document development and efficient cross‑regional collaboration. Address regionally specific activities, requirements and processes as needed to maintain high‑quality, timely deliverables.
- Ensure regulatory compliance and scientific quality: Maintain rigorous adherence to applicable regulatory requirements, industry standards, corporate guidelines and established medical writing practices. Implement and oversee quality control processes throughout document development and review, ensuring accuracy, completeness, consistency, traceability and scientific credibility.
- Translate complex clinical data into compelling scientific narratives: Critically interpret, synthesize and present clinical data and other complex scientific information, transforming technical findings into coherent, evidence‑based clinical and regulatory documentation that supports informed decision‑making and regulatory review.
- Maintain document accuracy throughout development: Proactively update, revise and refine clinical and regulatory documents to incorporate emerging clinical information, evolving program requirements, stakeholder feedback and relevant regulatory changes, ensuring documentation remains current and fit for purpose.
- Exercise independent judgment and solve complex challenges: Navigate complex medical writing and regulatory documentation challenges by evaluating multiple sources of information, questioning existing approaches and identifying practical solutions. Apply sound scientific judgment and introduce new perspectives where established processes may benefit from improvement.
- Contribute to medical writing strategy and continuous improvement: Provide expert input into departmental goals

📌 Senior Manager, Medical Writing (Melbourne)
🏢 Moderna Therapeutics
📍 Melbourne