Senior Regulatory Writing Lead - Remote & Mentorship

Regulatory Toolkit; United States; Hybrid; USD 140,000 - 189,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Discretionary annual bonus

Flexible work options

Job summary

Amgen seeks a Regulatory Writing Senior Manager to lead writing for complex regulatory submissions and mentor junior writers. You will oversee authoring for Clinical Study Reports, Investigator Brochures, and eCTD Module 2 Clinical Summary Documents, coordinating with cross-functional teams and ensuring SOP compliance.

Responsibilities include supervising contract/freelance writers, guiding publication strategies, and generating timelines for regulatory deliverables.

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

Responsibilities

• Author or oversee the authoring of regulatory submission documents.
• Conduct the formal review and approval of authored documents.
• With limited supervision, lead regulatory writing activities for complex product submissions.
• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team).
• 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.

Education

Doctorate degree (2+ years related exp)

Master’s degree (6+ years related exp)

Bachelor’s degree (8+ years related exp)

Associate’s degree (10+ years related exp)

High school diploma / GED (12 years related exp)

Job description

Amgen seeks a Regulatory Writing Senior Manager to lead writing for complex regulatory submissions and mentor junior writers. You will oversee authoring for Clinical Study Reports, Investigator Brochures, and eCTD Module 2 Clinical Summary Documents, coordinating with cross-functional teams and ensuring SOP compliance.

Responsibilities include supervising contract/freelance writers, guiding publication strategies, and generating timelines for regulatory deliverables.