Manager, Global Labeling
Cision
full-time
Posted on:
Location Type: Hybrid
Location: Nutley • Connecticut • Illinois • United States
Visit company websiteExplore more
Salary
💰 $102,300 - $134,300 per year
About the role
- Develops, revises, tracks and approves packaging documents including issuance of Core Labeling Change Notifications, International Labeling Change Notifications, and New Core Labeling Notifications;
- Ensures packaging content and artwork is compliant with internal labeling policies, standard operating procedures and worldwide health authority regulations.
- Maintains and tracks labeling/packaging documents in the labeling repository and/or electronic system.
- Monitors worldwide regulations pertaining to labeling and assists in the maintenance of standard operating procedures.
- Assists with preparing submission-ready labeling documents.
- Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for labeling medical products.
- Develops product labeling such as target product profiles (TPP), company core data sheets (CCDS), instructions for use, and safety data sheets.
- Monitors process of any changes in labeling regulations in the US and/or abroad.
- Reviews labeling change information, and ensures that it is supported by the data and consistent with the application.
- May review promotional and commercial communication material.
- Support Global Labeling Leads in daily operational labeling activities (US and global);
- Manage and maintain US SPL, drug listings, and establishment registrations;
- Triage, review, and track Country Product Information (CPI); and perform operational activities that support Global Labeling deliverables.
Requirements
- BS degree (or higher) in life science
- A minimum of 4 years of experience in the pharmaceutical industry
- A minimum of 2 years of experience in product labeling/labeling regulations
- Strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral)
- Attention to detail and ability to work under tight timelines, and across teams and regions
- Experience in both local and global regulatory labeling environments
- Must be a team-oriented individual with personal commitment to human relations, integrity, giving and receiving feedback, adaptability, and a diverse working environment
- Able to work under pressure and enforce company-wide standards
- Strong working knowledge of Microsoft Office applications, document management systems, labeling text verification systems as well as related labeling software and trackers
Benefits
- Eisai Inc. Annual Incentive Plan
- Company employee benefit programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
product labelinglabeling regulationslabeling compliancelabeling document preparationlabeling text verificationsubmission-ready documentstarget product profilescompany core data sheetssafety data sheetsdrug listings
Soft skills
project managementproblem solvingstrategic thinkingnegotiationinterpersonal skillscommunication skillsattention to detailadaptabilityteam-orientedintegrity
Certifications
BS degree in life science