About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
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 have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
As a Medical Writing Lead at Astellas Pharma, you will play a pivotal role in shaping the future of healthcare. You will lead the development of high quality regulatory documents that are essential for advancing innovative therapies. Your expertise will directly contribute to our mission of improving lives worldwide through cutting-edge innovation and precision medicine. Join us in our commitment to changing tomorrow and make a meaningful impact in the lives of patients.
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:
• Act as the primary Global Medical Writing Lead (GMWRL) for all assigned programs, focusing on mid- to late-stage development.
• Provide intellectual leadership and contribute document knowledge and expertise to the global project team.
• Review documents within various therapeutic area to ensure consistency with established strategies and document history, ensuring high-quality outputs that meet regulatory requirements.
• Independently implement adjustments in document content to meet specific team requirements while adhering to provided templates.
• Participate in departmental project activities and initiatives to enhance performance and improve processes.
Essential Knowledge & Experience:
• Strong track record in medical writing within a pharmaceutical or healthcare related environment.
• High level of technical expertise in all document types produced by medical writing.
• Experience managing/supervising activities associated with the creation of regulated documents.
• Substantial experience leading and managing creation of IND/IMPD and NDA/MAA components, briefing documents and responses to regulatory authorities.
• Excellent communication and leadership skills, with a strategic mindset and ability to manage multiple priorities.
• Ability to work independently as well as with cross-functional teams.
Preferred Experience:
• Familiarity with preparing for advisory committees is a plus.
Education:
• Bachelor's Degree, PhD/Pharm D or MS/MA/MPH an advantage or equivalent.
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. Candidates must be located within a commutable distance of the office.
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-PG1