Global Labelling Manager

Ipsen

Jun 17

Applications are closed

Job
Full-time
Senior & Expert Level
Science
Business, Operations & Strategy
London

Requirements

Education / Certifications:
Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Safety, Biological Sciences, Medical Writing)
Graduate degree in Regulatory or related discipline preferred
Familiarity with labelling regulations in other countries/region (e.g. USA, EU, Japan, China) is desired
Experience:
Minimum of 7 years of experience in global labelling activities or management of EU/US product information
Experience in Pharma/biotechnologies and Global labelling - Knowledge of labelling within a Therapeutic area
Regulatory, safety, scientific, or medical writing experience
Project Management experience, experience managing individual and group projects of moderate complexity
Languages:
Fluency in English as business language
Key Technical Competencies Required;
Regulatory Affairs experience is essential with direct experience managing CCDSs, labeling submissions and related activities: experience and working knowledge with SPL and PLR requirements and/or SmPC and QRD requirements
Knowledge of pharmaceutical regulation related to product information in EU and US and ability to maintain awareness of new external guidelines/policies pertaining to product information
Excellent writing skills especially suitable for labelling, proven experience in drafting labelling content
Data analysis skills and high level of attention to detail - ability to work proactively through labelling revisions and the product review process
Knowledge of therapeutic area(s) and be able to develop a sound knowledge of a product portfolio
Strong collaboration, presentation, communication and interpersonal skills with ability to establish effective working relationships with a diverse range of stakeholders
Proven project management, leading teams from multiple functional areas
Excellent verbal and written communication skills; strong technical writing and presentation skills
Strong scientific background and/or experience, working knowledge of medical terminology and drug safety
Highly organized with the ability to manage complex projects and timelines
Must be able to work as a team member and independently
Experience with E2E global labeling processes
Experience in review process, standards, and industry best practice pertaining to labeling
Experience working in a Documentum-based document management system (EDMS)

Responsibilities

Leads and works collaboratively with submission/product teams to develop & maintain Company Core Data Sheet (CCDS) and other key global labelling documents for assigned products
Provides strategic guidance on labelling requirements and labelling trends, gets alignment on proposed wording
Presents to Executive Labelling Committee (ELC) with product team or circulates CCDS updates (in conjunction with EU-USPI updates when required) to obtain internal approval or escalate significant labelling issues, as appropriate
Manages and disseminates CCDS updates to defined stakeholders within required timelines and as per agreement with partners, as appropriate
Works closely with GRA Compliance group and Global Regulatory teams to ensure oversight of CCDS updates in Ipsen territory by monitoring timely implementation in countries
Supports Global and Local Regulatory Affairs teams for the implementation of CCDS content in local product information and reporting of non-conformances (non-alignment with required CCDS changes)
Works with the Global Regulatory/Submission teams on planning, managing and implementing labelling updates
Maintains all labelling documents in accordance with Ipsen company policies, procedures and technologies
Participates in other projects and activities for the implementation of changes to processes within Global Labelling
Ensures Global Labelling documents are of the highest quality and represent the safe and effective use of the product
Provides input for the production of high-quality documents supporting changes to the CCDS
Manages CCDS annotations and check consistency with source documents and within CCDS sections
Assists in preparation of responses to labeling-related Health Authority queries
Reviews and approves non-conformances from CCDSs; ensures deviations from labeling procedures and policies are addressed appropriately and escalated to ELC as appropriate
Maintains awareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information
Represents labelling on product-specific global regulatory subteams
Participates to mandatory trainings and completes training records
Knowledge, abilities & experience

FAQs

What are the main responsibilities of a Global Labelling Manager?

The main responsibilities of a Global Labelling Manager include developing and maintaining core labelling documents, providing guidance on labelling strategy, overseeing global labelling activities, contributing to the development of the labelling function, and ensuring compliance with SOPs.

What is the purpose of developing and maintaining core labelling documents?

Developing and maintaining core labelling documents ensures that product information is accurate, up-to-date, and compliant with regulatory requirements throughout the product life cycle.

How does a Global Labelling Manager support product teams and senior management?

A Global Labelling Manager provides labelling guidance to support product teams and senior management in defining labelling strategy, ensuring that product information is clear, accurate, and compliant with regulatory requirements.

What is the role of a Global Labelling Manager in implementing labelling processes?

A Global Labelling Manager guides teams to ensure compliance with SOPs and contributes to the development of the labelling function, implementing processes to streamline the labelling process and ensure accuracy and compliance.

Ipsen

Manufacturing & Electronics

Industry

5001-10,000

Employees

Mission & Purpose

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in 88 countries