Clinical Documentation Lead

Astellas Pharma Inc.; United Kingdom; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading global pharmaceutical company in the United Kingdom is seeking a Clinical Documentation Lead to manage clinical trial documentation. Responsibilities include coordinating documentation, collaborating with stakeholders, and ensuring compliance with regulatory standards. The role offers a hybrid working model, requiring a blend of home and office work. The ideal candidate will have strong project management skills and attention to detail.

Benefits

Hybrid working model

Flexible working schedule

Qualifications

• Experience in a pharmaceutical, CRO or healthcare environment preferable.
• Strong project and document governance management skills.
• Confident communicator, comfortable working with senior stakeholders.

Responsibilities

• Coordinate protocol and governance documentation for clinical trials.
• Collaborate with SMEs and stakeholders to ensure documents are review-ready.
• Manage multiple projects under tight timelines, adapting to shifting priorities.

Skills

Project management

Document governance

Communication with stakeholders

High attention to detail

Understanding of regulatory requirements

Education

BA/BS degree or equivalent experience

Job description

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Description Clinical Documentation LeadAbout Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: Pivotal role responsible for the coordination, governance, and management of clinical trial documentation across a diverse portfolio. Collaborates with subject matter experts and senior stakeholders to ensure all trial-related documents meet regulatory and internal standards and are managed efficiently throughout the lifecycle of the study. Hybrid Working: At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver. Key Responsibilities: •Coordinate protocol and governance documentation for clinical trials • Collaborate with SMEs and stakeholders to ensure documents are review-ready, correctly formatted, and submitted on time • Lead meetings, track feedback, and manage documentation workflows • Oversee document reviews in internal systems, ensuring compliance and accuracy • Manage multiple projects under tight timelines, adapting to shifting priorities Essential Knowledge & Experience: • Experience in a pharmaceutical, CRO or healthcare environment preferable • Strong project, document governance and protocol management • Confident communicator, comfortable working with senior stakeholders • High attention to detail and understanding of confidentiality and regulatory requirements Education: • BA/BS degree or equivalent experience. Additional Information: • This is a permanent, full-time position. • This position is based in the United Kingdom. • This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone office. Flexibility may be required in line with business needs. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Addlestone #LI-Hybrid #LI-ND1