General Information
Job Advert Title
Regulatory Medical Writing Scientist
Location
United Kingdom
Function/Business Area
Missing req details TBC
Employment Class
Permanent
Description
Regulatory Medical Writing Scientist About 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.
Learn more at Astellas.com.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 Regulatory 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 regulatory and 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 regulatory 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.
- Applying experience to adapting document content within established templates to meet specific project needs.
- Supporting a Medical Writing Lead in delivering program-level activities, particularly within early-stage global development projects.
Required Qualifications - BA/BS degree or equivalent and/or advanced degree with relevant experience
- Experience as a regulatory writing scientist in the pharmaceutical industry
- Excellent communication and interpersonal skills
- Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment
- Ability to exercise sound judgment, tact, diplomacy, integrity and professionalism in all interactions.
- Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
- Proficiency in computer systems including MS Word, MS Excel, MS PowerPoint, and MS Outlook
Preferred Qualifications - MS/MA/advanced degree with proven experience as a Regulatory Writing Scientist in the pharmaceutical industry
- Technical expert for several the major document types produced by medical writing, including IND/NDA/MAA components.
What awaits you at Astellas? - Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors - Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits Careers | Astellas
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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