Medical Writing Lead

Astellas Pharma Inc.; United Kingdom; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Medical Writing Lead to join their team. In this role, you will shape the future of healthcare by leading the development of high-quality regulatory documents essential for advancing therapies, while contributing to the mission of improving lives worldwide through innovation in medicine. The position offers a hybrid working model, allowing flexibility in work location while ensuring collaborative in-office engagement.

Qualifications

• Proven track record in medical writing within the pharmaceutical or healthcare sector.
• Technical expertise in various document types produced by medical writing.
• Experience with IND/IMPD, NDA/MAA components, briefing documents, and regulatory responses.

Responsibilities

• Lead the development of high-quality regulatory documents.
• Provide leadership and expertise to the global project team.
• Review documents to ensure consistency, quality, and regulatory compliance.

Skills

Communication

Leadership

Strategic Skills

Education

Bachelor's Degree

PhD/PharmD or MS/MA/MPH

Job description

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Description

Medical Writing Lead

About Astellas:

At Astellas, we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on areas of greatest potential and developing solutions for high patient need, often in rare or under-served diseases and critical conditions. We work directly with patients, doctors, and healthcare professionals to ensure patient and clinical needs guide our development activities at every stage.

Our global vision for Patient Centricity emphasizes supporting the development of innovative health solutions through a deep understanding of the patient experience. Patient Centricity is a guiding principle for action at Astellas, and we aim to embed this awareness into our daily practices across all roles and divisions.

We collaborate with regulatory authorities and payers to improve access to therapies, leveraging real-world evidence to inform decisions that benefit patients and caregivers. Beyond medicines, we support initiatives that enhance awareness, education, access, and standards of care.

The Opportunity:

As a Medical Writing Lead at Astellas Pharma, you will shape the future of healthcare by leading the development of high-quality regulatory documents essential for advancing therapies. Your expertise will contribute to our mission of improving lives worldwide through innovation and precision medicine. Join us in making a meaningful impact in patients' lives.

Hybrid Working:

We offer a hybrid working model that balances in-office collaboration with remote work flexibility, enabling a productive environment tailored to your success.

Key Activities:

1. Act as the primary Global Medical Writing Lead (GMWRL) for assigned programs, focusing on mid- to late-stage development.
2. Provide leadership and expertise to the global project team on document development.
3. Review documents across therapeutic areas to ensure consistency, quality, and regulatory compliance.
4. Implement content adjustments independently to meet team requirements using provided templates.
5. Participate in departmental initiatives to enhance performance and processes.

Essential Knowledge & Experience:

• Proven track record in medical writing within the pharmaceutical or healthcare sector.
• Technical expertise in various document types produced by medical writing.
• Experience managing regulated document creation activities.
• Experience with IND/IMPD, NDA/MAA components, briefing documents, and regulatory responses.
• Strong communication, leadership, and strategic skills, with the ability to manage multiple priorities.
• Ability to work independently and with cross-functional teams.

Preferred Experience:

• Familiarity with preparing for advisory committees is advantageous.

Education/Qualifications:

• Bachelor's Degree or equivalent; PhD/PharmD or MS/MA/MPH is a plus.

Additional Information:

• This is a permanent, full-time role based in the United Kingdom.
• Follows our hybrid working model with at least 1 day per quarter in the Addlestone office.
• Flexibility may be required based on business needs.

We are an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, veteran status, or other protected characteristics.