Job Title: Medical Writer – Regulatory Submissions
Location: Flexible (Remote and On-Site Opportunities Available)
Employment Type: Full-Time
For over 40 years, Amgen has been at the forefront of biotechnology, using cutting-edge science and data to discover, develop, manufacture, and deliver medicines that make a real difference in the lives of millions of patients. Our commitment to innovation and excellence has driven breakthroughs in oncology, inflammation, general medicine, and rare diseases. Now is your chance to join our team and help transform healthcare worldwide.
Let’s do this. Let’s change the world.
As a Medical Writer, you’ll play a vital role in developing and delivering regulatory and scientific submission documents. Collaborating across teams, you will ensure compliance with global regulatory standards while supporting Amgen’s mission to provide innovative treatments for patients.
Document Creation:
Author and secure approval for regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Protocols, Briefing Documents, Pediatric Investigation Plans, and more.
Review and Approval:
Conduct thorough reviews of documents, ensuring adherence to applicable standard operating procedures (SOPs).
Project Leadership:
Manage regulatory writing activities for submissions, including drug applications and biologics license applications.
Functional Team Leadership:
Act as a functional area lead on key teams such as the Global Regulatory Team, Evidence Generation Team, or Label Working Group.
Collaboration:
Work with contract and freelance writers as necessary, providing functional input for global regulatory plans and team goals.
Training and Mentorship:
Train and mentor junior writers, contributing to their professional growth.
Timelines and Planning:
Develop and manage timelines for document completion, ensuring alignment with team goals.
Continuous Learning:
Stay current with advancements in technology and industry regulations to ensure compliance and innovation.
We value diversity and the unique contributions of each team member. For this role, we seek an experienced professional with the following qualifications:
Technical Skills:
Soft Skills:
At Amgen, we’re not just developing medicines—we’re building careers. From our competitive salaries to our comprehensive benefits, we are dedicated to your growth and well-being.
Benefits Include:
Join us for a career that defies imagination. Transform lives, including your own, by becoming part of Amgen’s mission-driven team.
Visit careers.amgen.com to apply.
Amgen is an Equal Opportunity Employer, committed to diversity and inclusion. We welcome applicants from all backgrounds and provide accommodations for individuals with disabilities throughout the hiring process.
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Sheffield |Oxfordshire :
Witney |Ontario :
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