Senior Regulatory Writing Manager
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Job Description
Regulatory writing leader developing complex product submissions for Amgen, a global biotechnology company. Leading document authoring, product-team strategy, reviewers, and junior writers.
Responsibilities:
- Serve as the functional area lead on product teams
- Lead writing activities for complex product submissions
- Author or oversee 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 formal review and approval of authored documents following applicable standard operating procedures
- Lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
- Serve as functional area lead on Global Regulatory Team, Evidence Generation Team, Global Safety Team, and 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
- Generate document timelines
Requirements:
- 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
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry
Benefits:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
- Career development opportunities
- Work/life balance
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