Regulatory Writing Senior Manager

Amgen; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Time-off program

Remote work options

Job summary

Amgen in Washington, DC is seeking a Regulatory Writing Senior Manager to lead the authoring and oversight of key regulatory submission documents, including Clinical Study Reports, Investigator Brochures, and eCTD Module 2 Clinical Summary Documents. This role requires advanced degrees and extensive medical writing experience in biotech/pharmaceuticals.

The position includes mentoring contract and freelance writers, coordinating timelines, and collaborating across Global Regulatory Plans and

Qualifications

• Advanced degree in a relevant field and substantial experience in regulatory writing.
• Experience composing or supervising regulatory documents for biotech/pharmaceutical products.
• Proven ability to lead cross-functional regulatory teams and mentor writers.

Responsibilities

• Author or oversee regulatory submission documents (CSRs, Investigator Brochures, Responses to Questions, Protocols, ICFs, eCTD modules).
• Lead regulatory writing activities for complex product submissions with limited supervision.
• Serve as functional area lead on product teams and provide input for Global Regulatory Plans.

Skills

Regulatory writing

Medical writing

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Regulatory Writing Senior Manager

Live

What you will do

• Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
• Conduct the formal review and approval of authored documents, following applicable standard operating procedures
• With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
• Provide functional area input for Global Regulatory Plan and team goals
• Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
• Lead departmental and cross-departmental initiatives, as appropriate
• Generate document timelines

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 and 2 years of directly related experience
• OR
• Master’s degree and 6 years of directly related experience
• OR
• Bachelor’s degree and 8 years of directly related experience
• OR
• Associate’s degree and 10 years of directly related experience

Or

High school diploma / GED and 12 years of directly related experience

Preferred Qualifications:

• Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
• 5+years of experience in medical writing in the Biotech/Pharmaceutical industry

Thrive

What 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.

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

for a career that defies imagination

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

careers.amgen.com

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your 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.