Description Lead, Medical Writing ScientistAbout Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.
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Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Location and Working Environment This position is hybrid and will require you to be onsite 1 day per quarter in our Addlestone office. This position is a based in the UK. Astellas’ Responsible Flexibility Guidelines Statement - At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Purpose & Scope As a Medical Writing Scientist, you’ll take the lead on high-impact regulatory documents, driving strategy and clarity across complex submissions. Acting as the document lead, you’ll guide cross-functional teams through the development of critical materials such as INDs, NDAs, MAAs, regulatory responses, and integrated briefing packages. In this role, you won’t just write—you’ll shape the narrative. You’ll coordinate contributions from multidisciplinary experts, ensure consistency and scientific rigor, and keep projects moving forward with confidence and precision. You’ll also mentor and review the work of other writers, elevating the overall quality of deliverables. We’re looking for someone who brings strong scientific insight, a strategic mindset, and a passion for clear communication. Your expertise will be central to translating complex data into compelling, submission-ready documents that make a real impact. Role and Responsibilities •Acting as a lead medical writer for complex, strategically significant documents, including IND/NDA/MAA components, regulatory authority responses, and multi-component briefing packages. •Coordinating, managing, and facilitating all activities required for document completion within a cross-functional document team. •Developing comprehensive, agreed-upon document work plans, outlining all tasks and subtasks to enable efficient and effective team execution. •Providing intellectual leadership as a document specialist, contributing deep expertise and strategic insight to the team.. Continue: Role and Responsibilities •Participating in departmental project activities and collaborative initiatives. •Collecting, monitoring, and maintaining metrics related to document development and quality review, including supporting performance evaluation of contributing writers. •Resolving issues related to template usage, document content, and established processes to ensure consistency and compliance. •