Job Title : Senior Manager, Global Labeling
Duration : 12 months
Position type : W2 contract
Senior Manager, Global Labeling Strategy (50% Onsite)
Job Description :
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
Education :
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
Senior Marketing Manager - Global Launch Marketing
A company is looking for a Senior Marketing Manager, Launch Marketing for Petcare Dermatology. Key Responsibilities:Develop and execute global pre-launch plans, asset and market development for new productsAlign markets to specific pre-launch and launch activities and ensure local supportCollaborate...
Tax Senior Manager - Global Information Reporting
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC's Global Information Reporting (GIR) practice helps our clients comply with an international set of rules that are focused on information reporting and with...
Senior Program Manager Global Ship Design
A company is looking for a Senior Program Manager. ...
Tax SAP Global Trade Services Senior Manager
As a practitioner within Deloitte's Global Trade Advisory Practice, you'll have the opportunity to help clients get the most from their SAP investments-and help position businesses for the evolving digital economy. Our Global Trade Advisory practice is a national practice within Deloitte Tax LLP's I...
Senior Manager Global Payroll
A company is looking for a Senior Manager, Global Payroll. ...
Tax Senior Manager - US Payroll Operations - Global Employer Services
As part of the Global Employer Services (GES) business in Deloitte Tax, you will join a dynamic team delivering and growing the offering globally. If you are prepared and poised to take the next step in your career where you can help drive strategic initiatives across a global business platform, we ...
Senior Global Labeling Manager
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 Dec...
Senior Manager, Global Strategic Sourcing
The role reports to our Senior Director, Global Strategic Sourcing, and is part of the larger Foot Locker Global Procurement Center of Excellence. As Senior Manager of Global Strategic Sourcing, you will play a crucial role in developing, managing, and executing category strategies that support stra...
Senior Customer Success Manager
Every day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services. The Customer Success Manager functions as our customers’ trusted advisor and helps identify opportunities for co...
Senior Manager, Global Billing and Collections
Sprinklr is looking for an experienced and driven Global Senior Manager, Credit & Collections to join our team. The Senior Manager will play a key role within the Order to Cash team and broader Finance organization to provide real-time support and analytics. Manage and build a robust collection team...