Senior Manager, Global Labeling Strategy - Summit, United States - Ivory Systems

Description

Position available in the following locations:

Summit, NJ

Lawrenceville, NJ

New Brunswick, NJ

Devens, MA

San Diego, CA

Seattle or Bothell WA

Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (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.

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 medium to low complex projects in the Lifecycle Management (LCM) projects

Serves as primary contact for Labeling Strategy Team (LST), eg Global Regulatory Lead (GRL), Safety Management Team Lead (SMTL), 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

Reviews country labels to ensure labeling compliance

Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities

Participates in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals

o Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of Life Sciences with at least 2 years of Labeling / Regulatory Experience

Good Understanding of Drug Development and Commercialization of prescription medicines

Ability to understand regulatory implications of product strategy related to labeling development, assessment and management

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 medium complex projects

Excellent verbal and written communication skills

Keen attention to detail and accuracy

Ability to assimilate clinical and scientific information and present it in a concise manner

Ability to think creatively and good excellent problem-solving skills