Labeling Strategist

🔥 7 minutes ago

🇺🇸 United States – Remote

💵 $133k - $179.9k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

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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

• Develop and maintain quality core and regional labeling documents • Drive global labeling strategy for safe and effective use of Amgen products • Facilitate and manage end-to-end labeling processes for pre- and post-marketed products throughout their life cycle • Lead development of Core Labeling documents and US labeling deliverables • Chair and lead Labeling Working Groups and presentations to Cross-Functional Executive Labeling Board meetings • Develop and maintain Core Data Sheets, core patient information leaflets, core instructions for use, US Prescribing Information, patient prescribing information, and medication guides • Represent labeling on product-specific global regulatory teams • Inform global regulatory team decisions affecting portfolio assets • Provide strategic guidance on Target Product Labeling • Manage compounds with medium to high labeling complexity • Advise Labeling Strategists on labeling regulations, requirements, competitor labeling, and trends • Advise internal and external experts on document creation and manage document annotations • Provide strategic labeling advice for major regions • Collaborate with cross-functional teams to align global regulatory labeling plans with strategies • Review, provide feedback on, and approve deviations from core labeling • Escalate deviations from labeling procedures and policies • Assist with responses to labeling-related Health Authority queries • Manage review and approval of core DHCP letters • Contribute to Annual Reports, DSURs, PBRERs, and Product Quality Complaint reviews • Collaborate to provide solutions to labeling issues • Supervise direct reports and support career development, if applicable • Travel approximately 10% as needed

🎯 Requirements

• Doctorate degree and 2 years of related experience, OR Master’s degree and 4 years of related experience, OR Bachelor’s degree and 6 years of related experience, OR Associate’s degree and 10 years of related experience, OR high school diploma/GED and 12 years of related experience • Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, and industry standards • Knowledge of global labeling regulatory requirements, standards and processes • Demonstrated understanding of product development • Comprehensive understanding of biology and pharmacology relevant to the therapeutic area • Analytical thinking and critical judgment • Ability to manage multiple assignments and timeline-driven priorities • Substantial project management skills • Ability to independently develop thorough, practical solutions • Demonstrated ability to lead teams • Interpersonal, organizational, negotiation, conflict resolution, and communication skills • Strong technical writing skills • Excellent project management and attention to detail • Experience working in a Regulatory Information Management system • Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint • Preferred: degree in life science or medicine • Preferred: pharmaceutical industry regulatory affairs and/or product labeling experience • Preferred: product labeling expertise within a therapeutic area • Preferred: knowledge of FDA, EMA, and other international labeling regulations • Preferred: experience managing individual and group projects of high to moderate complexity • Preferred: experience with Veeva/Documentum-based document management systems • Sponsorship for this role is not guaranteed

🏖️ Benefits

• Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support • Reasonable accommodation for individuals with disabilities