Senior Manager, Global Labeling

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🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $129k - $169.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Cision

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2000

🤝 B2B

📱 Media

B2B • Media • Marketing

Cision is a global leader in media intelligence, offering a comprehensive suite of communications and PR solutions. The company's platform, CisionOne, provides media monitoring, analytics, and relationship management services to help clients understand, influence, and amplify their stories. Cision assists its customers in identifying and connecting with journalists and influencers, distributing meaningful public relations and marketing communications, and measuring their impact. With a range of brands including Brandwatch and PR Newswire, Cision supports PR and corporate communications, brand reputation management, social media insights, and investor relations.

📋 Description

• Facilitate and lead the development, review, approval, and maintenance of CCDS for assigned products • Represent the Global Regulatory Network Global Labeling Group on project teams • Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements • Coordinate and lead cross-functional teams in the development and lifetime maintenance of TPP, CCDS and CPI components for assigned products/projects • Provide tactical and strategic guidance to CPI development teams • Manage direct reports • Maintain labeling history documents and assist in responding to labeling-related queries

🎯 Requirements

• Minimum BS degree or higher in life science. • 8+ years of experience in drug development environment • Minimum 3-5 years of regulatory experience within the pharmaceutical industry. • Experience in global and/or local regulatory labeling environments is preferred. • Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling. • Knowledge of and experience with Asia and other markets labeling desirable. • Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines. • Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) • Attention to detail and ability to work under tight timelines.

🏖️ Benefits

• Eisai Inc. Annual Incentive Plan • Employee benefit programs