Principal Labelling Executive

Harefield, England, United Kingdom · Regulatory Affairs

Description

The Labelling Team work in close collaboration with Regulatory Affairs, Artwork, Medical, Clinical and Pharmacovigilance to ensure excellence in the quality of information contained within Norgine’s Company Core Data Sheets, co-ordinating safety submissions for centrally and locally registered details within agreed timelines and liaising with Regulatory and the Supply Chain to enable the implementation of such changes within the artwork components in pack. The Principal Labelling Executive is an integral part of the labelling process maintaining global product information to a high standard, ensuring that all changes that relate to the safety and efficacy of Norgine products are progressed efficiently and reach the patients and prescribers.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:


Requirements

Qualifications

Good degree in a relevant life science subject or equivalent

Competencies

A good understanding of the drug development and life-cycle management principles and processes, specifically labelling processes from signal to pack implementation

Excellent verbal and written communication skills. Ability to produce written regulatory or scientific communications with clarity, accuracy and rigor

Good attention to detail, ability to quickly assimilate therapeutic/product knowledge

Demonstrates an ability to analyse and summarise data to a high level

Excellent interpersonal skills

Works collaboratively and effectively both within RA and cross functionally

Ability to communicate clearly in English

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