Regulatory Writing Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Regulatory Writing Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.

• Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4)
• Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
• Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)
• Lead study timelines for regulatory documents and regulatory submission strategy
• Act as a functional area representative and lead on product teams
• Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
• Ensure quality of regulatory submission documents at all stages of development
• Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams
• Participate in departmental meetings, as well as departmental and cross-departmental initiatives

Win

What we expect of you

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

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Writing Regulatory or scientific submission/documents experience

Or

Bachelor’s degree and 4 years of Writing Regulatory or scientific submission/documents experience

Or

Associate’s degree and 8 years of Writing Regulatory or scientific submission/documents experience

Or

High school diploma / GED and 10 years of Writing Regulatory or scientific submission/documents experience

Preferred Qualifications:

• Masters or higher degree in biology, chemistry, or other scientific field
• 5+ years in writing clinical and regulatory documents
• Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical …