Principal Scientist (Director) – Global Labeling Lead Full-time

Principal Scientist, Global Labeling Lead

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 which provide the safe and effective use of products for patients and healthcare providers globally.

As part of Labeling Strategy function in Global Labeling, you will be accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU), US Labeling, and EU Labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of other country's Local Labeling.

Responsibilities include:

• Developing, maintaining, and implementing Core Labeling and target labeling for assigned products in line with internal standards and guidelines
• Developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
• Assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products
• Providing labeling expertise and guidance to teams, assimilating labeling precedence and competitor labeling, while ensuring compliance with applicable regulatory requirements
• Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products
• Leading (both direct reports and cross-functional teams) to develop, review and approve Core and Local Labeling documents
• Independently recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority
• Providing information to Global Labeling Compliance, as required, to support internal and external (i.e., Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert
• Evaluating risks associated with Core or Local Labeling content, developing mitigation strategies, and appropriately escalating issues to Global Labeling management and the Global Regulatory team
• Proficiency in crucial labeling requirements worldwide
• Contributing to the continuous improvements to the end-to-end labeling process, including labeling policies, procedures, quality, and system tools
• Providing guidance, coaching, training and may provide management support to other Global Labeling Leads

Education:

• Required: Bachelor's degree in a scientific or medically-related discipline.
• Preferred: Advanced degree (M.S., Pharm.D, Ph.D.).

Required Experience & Skills:

• Minimum of 7 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance)
• Skilled and effective at leading and mentoring team members and leading cross-functional labeling team (including senior management), exhibiting a combination of active listening skills and the confidence to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling project.
• Independent ability to assimilate clinical and scientific information, including labeling precedent and competitor labeling, and present it concisely. Understanding of medical concepts and terminology and how it applies to regulatory requirements and labeling strategy.
• Strong project management skills with the ability to handle multiple projects and prioritize work accordingly.
• Proactive problem-solving ability with the ability to make appropriate recommendations/decisions.
• Tolerance for ambiguity and action-oriented.
• 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

Salary range for this role is $173,200.00 – $272,600.00.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.