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.
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 (phase 1 through 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 (e.g., RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)
Manage 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 guidance 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 professional we seek is a standout colleague with these qualifications.
BASIC QUALIFICATIONS
Doctorate degree
Or
Master’s degree and 3 years of Writing Regulatory or scientific submission/documents experience
Or
Bachelor’s degree and 5 years of Writing Regulatory or scientific submission/documents experience
Or
Associate’s degree and 10 years of Writing Regulatory or scientific submission/documents experience
Or
High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
PREFERRED QUALIFICATIONS
MS or higher degree in biology, chemistry or other scientific discipline
5+ years of experience in writing clinical and regulatory documents
Ability to effectively operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
Ability to analyze medical data and interpret its significance
Advanced knowledge of scientific/technical writing and editing and of related regulatory guidance (e.g., ICH) governing regulatory submission documents and industry compliance
Advanced written/oral communication skills and attention to detail
Understanding and application of principles, concepts, theories and standards of scientific/technical field
Strong time and project management skills, negotiating skills, and perseverance with a drive for results
Knowledge of management skills and supervising the work of others
Strong leadership in a team environment
Strong negotiator