Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve been pioneering the biotech industry in our fight against the world’s toughest diseases. Focused on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As part of the Amgen team, you'll make a lasting impact on the lives of patients while also transforming your own career.
Our award-winning culture is collaborative, innovative, and science-based. If you thrive on challenges and the opportunities they present, you will thrive with Amgen. Join us to transform the lives of patients while advancing your career.
What You Will Do
In this vital role, you will author and gain approval of scientific and regulatory submission documents, ensuring alignment with global regulatory standards. You will maintain key business relationships within the product teams and, when requested, serve as a functional area lead on product teams. Additionally, you may manage regulatory writing activities, train and mentor junior writers, and assist with departmental initiatives.
Roles & Responsibilities
Regulatory Document Authoring: Author regulatory submission documents, such as:
Clinical Study Reports
Investigator Brochures
Responses to Questions
Protocols & Protocol Amendments
Informed Consent Forms
Clinical Overview Addenda
eCTD Module 2 Clinical Summary Documents
Briefing Documents
Pediatric Investigation Plans
Other regulatory documents
Document Review & Approval: Conduct formal review and approval of documents, ensuring compliance with standard operating procedures (SOPs).
Regulatory Writing Management: Under supervision, manage writing activities for product submissions, including new and supplemental drug applications and biologics license applications.
Team Leadership: Serve as functional area lead on product teams like the Global Regulatory Team, Evidence Generation Team, and others.
Training & Mentoring: Help train and mentor junior writers.
Document Timelines: Generate timelines for documents with input from the team.
Stay Informed: Keep abreast of relevant industry information and technology.
What We Expect of You
At Amgen, we recognize that everyone brings unique contributions to the table. We encourage individuals to use their unique skills to serve patients and contribute to our mission.
Basic Qualifications
Doctorate degree, OR
Master’s degree and 4 to 6 years of directly related experience, OR
Bachelor’s degree and 6 to 8 years of directly related experience, OR
Diploma and 10 to 12 years of directly related experience
Preferred Qualifications
Proficiency with Microsoft Office: Skilled in word processing and other Microsoft tools.
Scientific/Technical Writing: Strong knowledge of scientific writing, editing, and the clinical development process for new compounds.
Regulatory Knowledge: Understanding of ICH, GCP guidance, SOPs, and work instructions.
Project Management: Strong time and project management skills.
Leadership & Collaboration: Ability to lead teams, negotiate, collaborate, and make analytical judgments.
Communication Skills: Excellent written and oral communication with attention to detail.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We are committed to providing reasonable accommodations for individuals with disabilities throughout the job application process. Please contact us to request accommodation.
What You Can Expect From Us
We care about your professional growth and personal well-being. In addition to a competitive salary, Amgen offers a comprehensive Total Rewards Plan aligned with local industry standards. From collaborative culture to competitive benefits, we'll support your journey every step of the way.
Apply Now
Take the next step in your career by joining a company that transforms lives. Amgen is where your future begins.
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Sheffield |Oxfordshire :
Witney |Ontario :
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Greece |North Island :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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