Job Title: Medical Writer (Regulatory Submissions)
Location: United States (with flexible working arrangements available)
Contract Type: Full-time
Overview:
At Amgen, our shared mission to serve patients drives everything we do. We’re focused on pioneering innovative therapies in oncology, inflammation, general medicine, and rare diseases to improve the lives of millions. If you're passionate about transforming science into meaningful therapies, join our team of experts at Amgen. Together, we’ll change the world of healthcare and make a real difference in patient lives.
What You Will Do:
As a Medical Writer in our Regulatory Affairs team, you’ll be responsible for authoring key regulatory submission documents to ensure alignment with global regulatory standards. You’ll also contribute to product teams, collaborate with cross-functional colleagues, and potentially mentor junior writers.
Key Responsibilities:
Regulatory Submission Documents:
Author and gain approval for documents like Clinical Study Reports, Investigator Brochures, Protocols, Clinical Summaries, Pediatric Investigation Plans, and more.
Document Review:
Perform formal reviews of written documents, following applicable standard operating procedures (SOPs).
Manage Submission Writing:
Supervise the regulatory writing activities for product submissions (e.g., drug applications, biologics license applications).
Functional Area Lead:
Serve as the functional area lead on various product teams (e.g., Global Regulatory Team, Evidence Generation Team).
Mentorship & Training:
Mentor and train junior writers and contribute to their development.
Timelines & Planning:
Develop and manage document timelines with team input and ensure adherence to deadlines.
Continuous Learning:
Stay updated on professional advancements and relevant regulatory developments in clinical and scientific writing.
What We Expect from You:
Amgen is seeking a Medical Writer with strong technical and communication skills, a passion for regulatory science, and an ability to work collaboratively in a dynamic, fast-paced environment.
Basic Qualifications:
Doctorate degree
OR
Master’s degree and 4-6 years of relevant experience
OR
Bachelor’s degree and 6-8 years of relevant experience
OR
Diploma and 10-12 years of relevant experience in a related field
Preferred Qualifications:
Functional Skills:
Proficiency in Microsoft Office programs
Strong knowledge of scientific/technical writing and clinical development processes
Familiarity with International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines
Ability to understand and apply SOPs, guidance documents, and work instructions
Soft Skills:
Excellent written and oral communication skills
Strong leadership, negotiation, and collaboration abilities
Self-starter with the ability to manage multiple projects and deadlines
Strong attention to detail and problem-solving skills
What You Can Expect From Us:
At Amgen, we’re committed to the professional and personal growth of our employees. Along with a competitive base salary, we offer comprehensive benefits, including:
Healthcare and wellness plans for you and your family
Retirement savings plan with company contributions
Paid time off and company-wide shutdowns
Flexible work models, including remote work options
Career development opportunities to help you grow in your career
Apply Now and join Amgen to play a key role in transforming the lives of patients while advancing your own career.
Visit Amgen Careers to apply.
Amgen is an Equal Opportunity Employer. We encourage diversity and inclusion in the workplace and provide accommodations for individuals with disabilities during the application and interview process.
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