The Global Labelling Lead has overall accountability for the initial creation and relevant updates to labelling documents for their assigned products. This includes guiding the Labelling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralised, Mutual Recognition or Decentralised Procedures, and their associated Patient Labelling Documents.
Location: 100% Home based with occasional travel to the office for important meetings or training.
- Regulatory Authority driven documents such as the Core Safety Profile.
- Advise the Labeling Team on internal labeling guidance’s and policies and will raise awareness of important factors to consider when revising the label.
- Keep up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles.
- Knowledgeable on key labeling requirements worldwide, in order to ensure that CDS updates may be implemented globally.
- Review the downstream impact of CDS updates on Local Product Documents (LPD) and ensure that downstream impact on LPDs is considered during Labeling Team discussions.
- Advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text.
- Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
For further information on this opportunity please get in touch with Natalie Hopkins on 0207 183 5059
- SmPC experience
- CCDS experience
- USPI experience is beneficial but not necessary