Regulatory Writing Manager, US - Remote

1HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this. Lets change the world. In this vital role, you will prepare and coordinate the preparation of regulatory submission documents that align 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 -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)
• 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 professional we seek is a standout colleague with these qualifications.

Basic Qualifications

• Doctorate degree Or
• Masters degree and 3 years of Writing Regulatory or scientific submission/documents experience Or
• Bachelors degree and 5 years of Writing Regulatory or scientific submission/documents experience Or
• Associates 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

• Masters or higher degree in biology, chemistry, or other scientific fields
• 5+ years in writing clinical and regulatory documents
• Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
• Ability 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 submission documents and industry compliance
• Strong 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, engaging approach, and perseverance with a drive for results
• Leadership skills and ability to guide and influence the work of others
• Strong leadership in a collaborative team environment

ThriveWhat you can expect of us

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.

This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is 108,801 - 132,979.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now for a career that defies imagination

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

careers.amgen.com

Ready to Apply for the Job?

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Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a Partially Meets Expectations or higher. Please visit our Internal Transfer Guidelines for more detailed information.

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 cancers, 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.

We will ensure that individuals with disabilities are provided 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 accommodation.