Senior Regulatory Writing Lead — Remote

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

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