Regulatory Writing Senior Manager — Remote Submissions

Amgen; Thousand Oaks (CA); Hybrid; USD 140,000 - 189,000; Full time

Benefits offered by this job

Flexible work options including remote

Comprehensive benefits package

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off plans

Job summary

Amgen is seeking a Regulatory Writing Senior Manager to lead the authoring and oversight of regulatory submission documents for complex product programs in Thousand Oaks, CA. This role drives cross-functional collaboration and ensures adherence to SOPs while mentoring contract writers and guiding timelines.

The position requires advanced degrees and extensive medical writing experience within biotech/pharma, with flexible work arrangements and a comprehensive benefits package.

Qualifications

• Doctorate degree and 2 years of directly related experience
• Master’s degree and 6 years of directly related experience
• Bachelor’s degree and 8 years of directly related experience
• Associate’s degree and 10 years of directly related experience
• High school diploma / GED and 12 years of directly related experience

Responsibilities

• 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

Skills

Regulatory writing

Leadership

Cross-functional collaboration

Document management

People management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen is seeking a Regulatory Writing Senior Manager to lead the authoring and oversight of regulatory submission documents for complex product programs in Thousand Oaks, CA. This role drives cross-functional collaboration and ensures adherence to SOPs while mentoring contract writers and guiding timelines.

The position requires advanced degrees and extensive medical writing experience within biotech/pharma, with flexible work arrangements and a comprehensive benefits package.