Global Labelling Strategist

Varite • Virtual, NJ

83d • $40 - $50

About The Position

We are inviting applications for the role of Global Labelling Strategist. Global Labeling Strategy is part of Global Regulatory Strategic Operations which sits within Global Regulatory and Safety Sciences. The Associate Director, Global Labeling Strategy has overall accountability for initial creation and relevant updates to labeling documents (Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure.

Requirements

• Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience (CCDS / USPI / SmPC) or Bachelor of Life Sciences and at least 7 years of Labeling / Regulatory Experience

Nice To Haves

• Knowledge of Global Labeling Guidances, Drug Development and Commercialization of prescription medicines
• Proven understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS
• Proven ability to understand regulatory implications of product strategy related to labeling development, assessment and management

Responsibilities

• Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, internal processes and competitor analyses) for CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentralized Procedure) for high or medium complex projects in the Development and Lifecycle Management (LCM) projects
• Serves as primary contact for cross-functional Labeling Team Member (CFLT), eg Global Regulatory Team Lead (GRTL), Medical Surveillance Team Lead (MSTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally
• Coordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality
• Ensures effective planning of all cross-functional labeling activities
• Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities
• Reviews country labels to ensure labeling compliance
• Train and provide guidance for other Global Labeling Leads as needed
• Participates in / Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals
• Identifies opportunities to influence regulatory policy and climate with respect to labeling content

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree
• Number of Employees: 251-500 employees