Regulatory Writing Manager

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Regulatory Writing Manger

Live

What you will do

Let's do this. Let's change the world. In this vital role you will prepare scientific and regulatory documents that align with global regulatory standards.

• Independently write clinical study reports, Investigator Brochures, Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Bio-pharmaceutics, Clinical Overview, Table of All Studies, Briefing Documents, Risk Management Plans, Responses to Regulatory Agency Questions
• Independently write protocols, protocol amendments, and informed consent forms, as assigned
• Coordinate and manage the formal review and approval of scientific and regulatory documents
• Participate in the development of timelines for regulatory documents and lead preparation of assigned deliverables
• Contribute to regulatory submission strategy for teams in assigned product areas
• May serve as functional area representation on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
• May provide functional area input for Global Regulatory Plan and team goals
• May work with contract and freelance writers
• May participate in training and mentoring of junior medical writers
• May participate in departmental and cross-departmental initiatives, as appropriate
• Stay on top of professional information and technology through literature, symposia, and conferences

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The technical professional we seek is a strong writer with these qualifications.

Education & Experience (Basic)

• Doctorate degree OR
• Master's degree and 3 years of directly related experience OR
• Bachelor's degree and 5 years of directly related experience OR
• Associate's degree and 10 years of directly related experience OR
• High school diploma / GED and 12 years of directly related experience

Preferred Knowledge and Skills:

• Experience with regulatory documents in Regulatory Affairs, Research, Development, or related area with 5+ years experience in medical writing in the Biotech/Pharmaceutical industry
• Knowledge of scientific/technical writing and editing
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
• Understanding and application of principles, concepts, theories and standards of scientific/technical field
• Understands the core business process and purpose of the functional area in Amgen's commercialization process
• Leadership in a team environment

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.