Remote Senior Regulatory Writing Manager - Submissions

Amgen Inc.; Oregon; Hybrid; USD 140,000 - 189,000; Full time

Benefits offered by this job

Retirement and Savings Plan with team‑

Health and welfare plans

Stock-based long-term incentives

Flexible work models including remote

Job summary

Amgen in Oregon is seeking a Regulatory Writing Senior Manager to serve as the functional area lead on product teams and to manage writing activities for complex regulatory submissions.

You will mentor junior medical writers, supervise contract staff, and drive timelines for multiple documents across submissions, including CT Peers and Pediatric plans. Collaboration with regulatory, safety, and submission teams is essential to success.

Qualifications

• Doctorate, Master’s, Bachelor’s or Associate’s degree with years of related experience as listed in Basic Qualifications.
• Bachelor’s degree with 8+ years of related experience; Doctorate with 2+ years; Master’s with 6+ years; Associate’s with 10+ years; High school with 12+ years.

Responsibilities

• Author or oversee the authoring of regulatory submission documents (Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, ICFs, tables, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans).
• Conduct the formal review and approval of authored documents per SOPs.
• Lead regulatory writing activities for complex product submissions (new and supplemental drug/ biologics license applications).
• Serve as functional area lead on product teams (Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group).
• Provide functional area input for Global Regulatory Plan and team goals.
• Supervise contract and freelance writers and mentor junior medical writers.
• Lead departmental and cross-departmental initiatives and generate document timelines.

Skills

Regulatory writing

Medical writing

Leadership

Document management

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Job description

Amgen in Oregon is seeking a Regulatory Writing Senior Manager to serve as the functional area lead on product teams and to manage writing activities for complex regulatory submissions.

You will mentor junior medical writers, supervise contract staff, and drive timelines for multiple documents across submissions, including CT Peers and Pediatric plans. Collaboration with regulatory, safety, and submission teams is essential to success.