- 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 cross-functional 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 cross-functional 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
- 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 problem-solving skills
- Time management skills
-
Senior Manager, Global Labeling Strategy
1 week ago
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 ...
-
Associate Director, Global Labeling Strategy
5 days ago
Varite Short Hills, United StatesPay rate range: $60-65/hr. · Job 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 (Targe ...
-
Senior Manager Global Labeling Strategy
3 weeks ago
TSR Consulting New York, United StatesOur client, an established pharmaceutical company is in search of a Senior Manager Global Labeling Strategy to join their team on a W2 contract. · Job ID 79211 · Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Compa ...
-
Director Advertising
3 days ago
Bayer Whippany, United States**At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique pers ...
-
Secretary Department, Mental Health
2 weeks ago
RWJBarnabas Health Elizabeth, United States**Job Overview**: · In busy outpatient Behavioral Health program, make reminder calls to patients; copying, filing, faxing and scanning documents; scanning into electronic medical record; work orders; respond to medical record requests; provides phone and receptionist coverage fo ...
-
Unit Secretary, Day Stay Medical
3 weeks ago
RWJBarnabas Health Elizabeth, United States**Job Overview**: · Attend nursing station and perform clerical duties, reception duties, and requisition supplies, equipment and services as directed. · **Qualifications**: · - Required:_ · - High school diploma or equivalent · - Knowledge of medical terminology preferred · - Ab ...
-
Operator
2 weeks ago
Pembina Pipeline Corporation Morris, United States**Work Arrangement**: At Office / Facility · **Department**: Plant Operations Function · Pembina Pipeline Corporation is a dynamic energy transportation and midstream provider, serving customers for more than 65 years. Chances are, we do more than you think. We own pipelines that ...
-
Technical Consultant, Pci
3 weeks ago
Computer Design & Integration LLC Parsippany, United States**Computer Design & Integration (CDI LLC), an AHEAD Company** is an award-winning, nationally recognized organization that architects, deploys, and manages multiplatform hybrid IT solutions, including traditional IT, public, private and hybrid clouds. Recognized since 2000 as one ...
-
Merck Sharp & Dohme Rahway, United StatesWe are currently recruiting for a **Director, Global Marketing for Women's Cancer** for the oncology portfolio. The Global Marketing Director will lead overall strategy development for Women's cancer portfolio, develop our Women's cancer portfolio narrative and commercialization ...
-
Associate Vice President/therapeutic Area Head
2 weeks ago
Merck Sharp & Dohme Rahway, United StatesThe Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development. The AVP provides strategic over ...
-
Program Manager
3 days ago
OPARC Montclair, United States**Title**: Explore Program Manager** · **Function**:Supervise daily operations, employees, participants and services of OPARC's Explore Program (OE). · **Essential Functions**:Program Development** · - Develop and implement lesson plans/activities and curriculum. Evaluation of pr ...
-
Warehouse, Repack
4 days ago
Performance Foodservice Elizabeth, United States**Company Description** · Performance Foodservice, PFG's broadline distributor, maintains a unique relationship with a variety of local customers, including independent restaurants and hotels, healthcare facilities, schools, and quick-service eateries. A team of sales reps, chefs ...
-
Production Manager
4 days ago
Spectrum Ventures Parsippany, United StatesProduction Manager (m/f/d) Food Industry · You've found it - one of the most delicious jobs with spicy challenges: At Griesson - de Beukelaer, we love baking tasty cookies and snacks. Every day, we combine baking tradition with the latest technical standards. As a modern family-o ...
-
Brand Manager
5 days ago
B&G Foods, Inc. Parsippany, United StatesReady to be part of something special? · Join our Family · Job Description: The Brand Manager is responsible for managing the day-to-day marketing and general management duties across a portfolio of the company's largest grocery brands, as well as the development of long-term str ...
-
Production Supervisor
2 weeks ago
New Classic Cooking LLC Avenel, United States**SCOPE / POSITION DESCRIPTION**: · The Production Supervisor is an individual knowledgeable of factory's processes both in the Process as well as the packaging area. Trained in Food Safety principles and handles well the Food Safety Plan developed for our products. Is capable of ...
-
Executive Director, Global Marketing Hiv –
3 days ago
Merck Sharp & Dohme Rahway, United StatesThe Executive Director of Global Marketing for HIV - Long-Acting Treatment Programs, will be at the forefront of driving our global commercial success and making a meaningful impact on people living with HIV worldwide. In this critical role, you will lead the strategic commercial ...
-
Head of Operations, Genai
3 weeks ago
Meta New York, United StatesMeta is looking for an experienced, self-motivated Operations leader to join the Product Data Operations (PDO) team leading our work in GenAI. The PDO GenAI team provides critical data labeling that powers AI products across Meta's family of apps. As the Head of the PDO GenAI tea ...
-
Project Manager, Product Data Operations
2 weeks ago
Facebook App New York, United StatesThe Product Data Operations (PDO) team plays a critical role in product development at Meta. We provide data and insights that power artificial intelligence (AI), measurement and insight at the core of all Meta products. The team partners closely with product and engineering team ...
-
Partnerships Manager
3 weeks ago
Downtown Music New York, United StatesDowntown Artist & Label Services offers distribution, bespoke marketing solutions, and funding to entrepreneurial artists and their partners, ranging from emerging talent at the forefront of pop culture to the most storied managers and record labels. Downtown Music is owned and o ...
-
Associate Account Manager
2 weeks ago
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 ...
The Associate Director, Global Labeling Strategy - Short Hills, United States - Ampcus Incorporated
Description
Job 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 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.
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
