Job Description

Career Category Regulatory



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 Manager

Live

What you will do

Let's do this. Let's change the world. In this key 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 highly competent professional we seek is a go-getter with these qualifications.

Basic Qualifications:

Doctorate degree OR Master's degree and 3 years 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 field

5+ years of demonstrated professional experience in writing clinical and regulatory documents Ability to operate optimally in an environment that involves negotiation, persuasion, collaboration, and analytical judgment

Capability to analyze medical data and interpret its significance

Extensive knowledge of scientific/technical writing and editing and of related regulatory guidance (e.g., ICH) governing regulatory submissions and industry compliance

Outstanding written and verbal communication ability

Proficient in managing and evaluating complex, detailed information Understanding and application of principles, concepts, theories, and standards of scientific/technical field

Strong time and project management and prioritization skills, commitment, and perseverance with a drive for results

Foundational leadership skills and familiarity with supervision/ mentoring of others and oversight of their work

Strong leadership and collaboration experience in a team setting

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also 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 increase 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.

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