Medical Writing Lead

Job title:

Medical Writing Lead

Company

Astellas Pharma

Job description

Medical Writing LeadAbout Astellas:At Astellas we are a progressive health partner, delivering value and outcomes where needed.We pursue innovative science, focussing 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: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 activities:

• 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/Qualifications:

• Bachelor’s Degree or equivalent. PhD/Pharm D or MS/MA/MPH an advantage.

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-UK#LI-Hybrid#LI-EG1

Expected salary

Location

United Kingdom

Job date

Tue, 20 May 2025 22:02:35 GMT

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