- 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
- 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
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The Associate Director, Global Labeling Strategy
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Ampcus Incorporated Short Hills, United StatesJob Description: Job Description - The Associate Director, Global Labeling Strategy · 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 C ...
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Senior Manager, Global Labeling Strategy
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Ampcus Incorporated Short Hills, United StatesJob Description: Job Description - Senior Manager, Global Labeling Strategy · Location: Remote · Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) an ...
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Millwork Holdings Co., Inc. New York, United StatesAre you a movement maker? Are you seeking new and exciting career opportunities? · Here is what you need to know about the job: · We are seeking a highly skilled and customer-centric Associate Account Manager with expertise in costing within the swimwear industry to join our team ...
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Regulatory Affairs Specialist
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Director, Digital Marketing
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Pfizer New York, United StatesROLE SUMMARY · - Provide leadership for in line Lung Cancer products on behalf of the Medical Affairs team. · - Collaborates with Brand partners in developing product strategy and ensures consistency of approach and quality deliverables. · - As an integrated member of the Brand T ...
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Pfizer New York, United States**Job Description**: · - ROLE SUMMARY- Provide leadership for in line Lung Cancer products on behalf of the Medical Affairs team. · - Collaborates with Brand partners in developing product strategy and ensures consistency of approach and quality deliverables. · - As an integrated ...
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Analyst, Business Intelligence
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Phlebotomist-faculty Group Practice
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Wholesale Marketing Assistant
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Director of Pay Commercialization
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Pfizer New York, United StatesROLE SUMMARY · The Medical Director Hospital Products and Sterile Injectables is an integral member of the Specialty Care Hospital medical affairs team reporting to the VP, Global Medical Affairs Hospital. · - Drives the medical strategy and planning for the assigned Global Hospi ...
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AMC Networks Inc. New York, United StatesJob Description · - AMC Networks is home to many of the greatest stories and characters in TV and film and the premier destination for passionate and engaged fan communities around the world. · - We create and curate celebrated series and films across distinct brands and make the ...
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Ralph Lauren New York, United StatesRef #: · W146987 · Department: · Marketing · City: · New York · State/Province: · New York · Country: · United States · **Pay Range**: The pay range for this job is $ $186000 annually; actual pay is dependent on experience and geographic location. · **Benefits**:Base pay is only ...
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Allocator, Mens Polo, Dtc
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Senior Manager Global Labeling Strategy - New York, United States - TSR Consulting
Description
Our client, an established pharmaceutical company is in search of a Senior Manager Global Labeling Strategy to join their team on a W2 contract.
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.
Senior Manager Global Labeling Strategy professionals in New York City
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