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Senior Manager, Global Labeling Strategy
3 months ago
Job Title:
Senior Manager, Global Labeling Strategy
Job ID:
(phone number removed)
Location:
Lawrenceville, NJ, 08648
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.
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
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.
Contact
Satya S | Direct:
(phone number removed) | Email: |
URL:
(url removed)
