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Job Description

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, US - Remote

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 (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 another 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
• Sophisticated 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 skills
• 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 environment
• Ability to influence others and effectively negotiate

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.

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