[Hiring] Director, Global Labeling @Eisai US

Role Description

The Director of Global Labeling is a leadership position within the global labeling organization, responsible for shaping and executing global regulatory labeling strategies to support business objectives and patient needs. The incumbent will have both direct product responsibilities and will also provide oversight to a high-performing team of Labeling Strategists. Responsibilities include:

• Development and maintenance of labeling documents for US, EU, Growth, and Rest of World Markets.
• Management of labeling operations and contribution to regulatory labeling strategy for marketed products and products in development (neurology and oncology portfolios).
• Expertise on regulations governing labeling of pharmaceutical products globally.
• Acting as the global regulatory labeling representative on international project teams.
• Supporting a team of professionals located in the US and UK, including resource management, performance management, coaching, and mentoring.

Essential Functions:

• Leads cross-functional teams in the timely development of content for new or revised CCDS, USPI, EU SmPC, and Growth and Rest of World Markets labels for products.
• Acts as liaison between co-promote partners and Eisai stakeholders in the labeling process.
• Establishes and maintains processes and standards for global labeling.
• Maintains a centralized labeling repository within Eisai’s electronic document management system.
• Manages labeling development, review, and approval workflows within the electronic documents management system.
• Provides labeling support for Eisai US and EU Packaging Engineering functions.
• Ensures consistency of labeling across product lines and compliance with Eisai policies and procedures.
• Maintains expertise regarding key labeling requirements worldwide and stays current with labeling guidelines and regulations.

Qualifications

• Bachelors degree in life sciences required; higher degree preferred.
• Minimum of 10 years of experience in Regulatory, R&D, or related areas.
• Pharmaceutical experience required.
• Solid working knowledge of drug development process.
• Solid working knowledge and experience of global regulatory labeling environments and requirements.
• Strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal, and communication skills (written and oral).
• Ability to work under tight timelines and thrive under pressure.
• Attention to detail and ability to articulate findings.

Requirements

• Bachelors degree in life sciences required; higher degree preferred.
• Minimum of 10 years of experience in Regulatory, R&D, or related areas.
• Pharmaceutical experience required.
• Solid working knowledge of drug development process.
• Solid working knowledge and experience of global regulatory labeling environments and requirements.
• Strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal, and communication skills (written and oral).
• Ability to work under tight timelines and thrive under pressure.
• Attention to detail and ability to articulate findings.

Benefits

• The annual base salary range for the Director, Global Labeling is from $188,900-$247,900.
• This position is eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
• Employees are eligible to participate in Company employee benefit programs.
• For additional information on Company employee benefits programs, visit Eisai Benefits .