Senior Regulatory Writing Lead - Remote Options

Amgen SA; United States; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Generous PTO

Flexible remote work options

Job summary

Amgen seeks a Regulatory Writing Senior Manager to serve as the functional area lead on product teams, directing writing activities for complex regulatory submissions and mentoring junior writers.

You will oversee the preparation and review of key documents, including clinical study reports, investigator brochures, and eCTD modules, coordinating with cross-functional partners to ensure timely, compliant submissions.

Qualifications

• Doctorate or professional equivalent with related experience in regulatory writing.
• Advanced degree combinations acceptable with sufficient regulatory submissions experience.
• Experience leading writing teams and cross-functional collaboration is preferred.

Responsibilities

• Lead authoring or oversee regulatory submission documents (clinical study reports, investigator brochures, responses to questions, and eCTD modules).
• Supervise contract and freelance writers; mentor junior medical writers.
• Coordinate with Global Regulatory Team and other stakeholders to ensure timely submissions.
• Generate document timelines and supervise submission processes.

Skills

Regulatory writing

Leadership

Mentoring

Cross-functional collaboration

Timeline management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

eCTD tools

Job description

Amgen seeks a Regulatory Writing Senior Manager to serve as the functional area lead on product teams, directing writing activities for complex regulatory submissions and mentoring junior writers.

You will oversee the preparation and review of key documents, including clinical study reports, investigator brochures, and eCTD modules, coordinating with cross-functional partners to ensure timely, compliant submissions.