Labeling Strategist

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and uphold quality core and regional labeling documents.

• Lead the global labeling strategy to ensure the safe and effective use of Amgen products.

• Oversee and manage the complete labeling processes for both pre- and post-marketed products throughout their lifecycle.

• Spearhead the development of Core Labeling documents and US labeling deliverables.

• Chair and guide Labeling Working Groups, as well as presentations at 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 within product-specific global regulatory teams.

• Influence decisions made by the global regulatory team that affect portfolio assets.

• Offer strategic guidance on Target Product Labeling.

• Manage compounds that possess medium to high labeling complexity.

• Advise Labeling Strategists regarding labeling regulations, requirements, competitor labeling, and industry trends.

• Provide guidance to internal and external experts on document creation and manage annotations.

• Deliver strategic labeling insights for major regions.

• Collaborate with cross-functional teams to ensure global regulatory labeling plans align with overall strategies.

• Review, provide feedback on, and approve any deviations from core labeling.

• Escalate any deviations from labeling procedures and policies.

• Assist in responding to Health Authority queries related to labeling.

• Manage the review and approval process of core DHCP letters.

• Contribute to Annual Reports, DSURs, PBRERs, and Product Quality Complaint reviews.

• Collaborate to devise solutions for labeling challenges.

• Supervise direct reports and support their career development, if applicable.

• Travel approximately 10% as necessary.

⛳️ Requirements

• Doctorate degree with 2 years of relevant experience, OR a Master’s degree with 4 years of relevant experience, OR a Bachelor’s degree with 6 years of relevant experience, OR an Associate’s degree with 10 years of relevant experience, OR a high school diploma/GED with 12 years of relevant experience.

• Extensive knowledge of regulatory affairs and familiarity with related concepts, procedures, practices, and industry standards.

• Understanding of global labeling regulatory requirements, standards, and processes.

• Proven knowledge of product development.

• In-depth understanding of biology and pharmacology pertinent to the therapeutic area.

• Strong analytical thinking and critical judgment abilities.

• Capability to manage multiple assignments and timeline-driven priorities.

• Significant project management expertise.

• Ability to independently formulate thorough and practical solutions.

• Proven capability to lead teams effectively.

• Strong interpersonal, organizational, negotiation, conflict resolution, and communication skills.

• Excellent technical writing skills.

• Exceptional project management skills and attention to detail.

• Experience with a Regulatory Information Management system.

• Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.

• Preferred: degree in life sciences or medicine.

• Preferred: experience in pharmaceutical industry regulatory affairs and/or product labeling.

• Preferred: expertise in product labeling 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 position is not guaranteed.

🏝️ Benefits

• Retirement and Savings Plan with generous contributions from the company.

• Comprehensive 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 feasible.

• Opportunities for career development.

• Support for work/life balance.

• Reasonable accommodations for individuals with disabilities.