Principal Scientist (Director) - Global Labeling Lead

Job Description We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high‑quality and compliant labeling documents that provide the safe and effective use of products for patients and healthcare providers worldwide. Responsibilities Develop, maintain, and implement core labeling and target labeling for assigned products in line with internal standards and guidelines. Develop, maintain, and implement US labeling for assigned products in accordance with regulatory requirements and internal standards. Assist with developing and maintaining local labeling (EU and other regions) for assigned products. Provide labeling expertise and guidance to cross‑functional teams, assimilating labeling precedents and competitor labeling while ensuring regulatory compliance. Serve as the global regulatory labeling point of contact on Regulatory Affairs sub‑teams to deliver labeling documents that meet quality, compliance, and regulatory requirements for timely submissions. Lead direct reports and cross‑functional teams to develop, review, and approve core and local labeling documents. Recommend labeling strategies and language for inclusion in core or local labeling during development or responses to health authorities. Provide information to Global Labeling Compliance to support internal and external requirements and audit/inspection activities. Evaluate risks associated with core or local labeling content, develop mitigation strategies, and appropriately elevate issues to Global Labeling management and the Global Regulatory team. Maintain proficiency in labeling requirements worldwide and contribute to continuous improvement of the end‑to‑end labeling process, including policies, procedures, quality, and system tools. Provide guidance, coaching, and training, and offer management support to other Global Labeling Leads. Qualifications Education : Bachelor's degree in a scientific or medically related discipline (required); advanced degree (M.S., Pharm.D., Ph.D.) preferred. Experience & Skills : Minimum 7 years of labeling experience or related experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance). Skilled at leading and mentoring team members and cross‑functional labeling teams, exhibiting active listening, confidence, and the ability to drive consensus and oversee project completion. Independent ability to assimilate clinical and scientific information, labeling precedents, and competitor labeling, and present it concisely. Understanding of medical concepts and terminology and how they apply to regulatory requirements and labeling strategy. Strong project management skills with the ability to handle multiple projects and prioritize work. Proactive problem‑solving ability with the capacity to make appropriate recommendations or decisions. Tolerance for ambiguity and an action‑oriented mindset. Excellent written and oral communication skills. Strong interpersonal skills. Attention to detail and accuracy. Ability to influence and negotiate. Required skills: Adaptability, Clinical Judgment, Data Quality Assurance, Detail‑Oriented, Innovation, Policy Implementation, Publications Management, Records Retention Management, Regulatory Compliance Audits, Regulatory Submissions, Regulatory Training, Team Collaboration, Technical Documentation Management, Technical Writing, Training and Development. Preferred skills: Current employees, contingent workers, and US & Puerto Rico residents (applicable). Salary and Benefits Salary Range: $173,200.00 – $272,600.00. Employees may be eligible for annual bonus and long‑term incentive plans, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, and other insurance benefits for employees and families; retirement benefits, including 401(k); paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity Statement We are an Equal Employment Opportunity Employer. All employees and applicants for employment are provided equal opportunities and protected from discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr