Senior Regulatory Writing Manager

🔥 16 minutes ago

🇺🇸 United States – Remote

💵 $139.6k - $188.8k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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