The Associate Director Global Labeling Strategy

Job Description: Job Description The Associate Director Global Labeling Strategy
Location: Remote
Bill rate: $55/hr

The Associate Director Global Labeling Strategy for Early Asset 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.

Drive the labeling strategy to early development activities to ensure consideration of labeling in claims development programs. Ensures that the labeling strategy is aligned with the overall product regulatory registration commercial and development strategy.
Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations and competitor analyses) for Target Product Labeling 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 crossfunctional 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
Contributes from the labeling perspective/labeling environment to Clinical Study designs protocols Investigator Brochures and Briefing Books.
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 crossfunctional labeling activities
Reviews country labels to ensure labeling compliance and adequacy to the regulatory strategy.
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


o 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
o Knowledge of Global Labeling Guidances Drug Development and Commercialization of prescription medicines
o Understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS
A understanding of pharmaceutical drug development.
Previous experience with Health Authorities bodies
Proven understanding of the dynamics and purpose of the Target Product Labeling and Company Core Data Sheets (CCDS) and their implications
Experience in developing of Target Product Labeling Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling. Proven ability to understand regulatory implications of product strategy related to labeling development assessment and management
Demonstrated ability to develop strong and positive working relationships across diverse teams and within a global environment
Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making
Experience in managing high to medium complex projects
Excellent project management verbal and written communication skills
Keen attention to detail and accuracy coupled with the ability to think strategically
Ability to assimilate clinical and scientific information and present it in a concise manner and translate them into labeling content
Ability to think creatively and good excellent problemsolving skills
Time management skills
Additional Sills: Skills: No items to display.