Marketing / Communications - Advertising Manager II

Location : Remote

Job title : Global Labelling Strategist

Key Skills : Labelling, CCDS, SmPC, USPI

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.

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

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 LifeSciences and at least 7 years of Labeling / Regulatory Experience

Desired Experience

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