Remote Regulatory Writing Senior Manager, Biotech

Amgen Inc.; United States; Remote; USD 140,000 - 189,000; Full time

Benefits offered by this job

Comprehensive benefits

Annual bonus program

Stock-based incentives

Paid time off programs

Flexible remote work options

Job summary

Amgen Inc. in the United States is seeking a Regulatory Writing Senior Manager to lead writing activities for complex product submissions. You will serve as the functional area lead on product teams, oversee the preparation of key documents, and mentor junior writers.

This role requires advanced degrees and substantial regulatory writing experience in biotech/pharma. You will collaborate with cross-functional teams, manage timelines, and supervise contract writers while advancing global

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.
• Experience with regulatory documents in Regulatory Affairs, Research, Development or related area.
• 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry.

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

Project management

Mentoring

Cross-functional collaboration

Strategic planning

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen Inc. in the United States is seeking a Regulatory Writing Senior Manager to lead writing activities for complex product submissions. You will serve as the functional area lead on product teams, oversee the preparation of key documents, and mentor junior writers.

This role requires advanced degrees and substantial regulatory writing experience in biotech/pharma. You will collaborate with cross-functional teams, manage timelines, and supervise contract writers while advancing global