Hub Labelling Manager
Proclinical are in search for Hub Labelling Manager to be responsible for the preparation of local product documents and their local language documents for their assigned markets. This is an opportunity to work for a large pharmaceutical organisation while supporting global label development, submission and approvals.
- Interaction with other cross functional roles in the delivery and management of labelling text through the appropriate processes and systems
- Communicate, plan, prioritise and deliver labelling documents according to company targets and submission requirements.
- Development of subject matter expertise for assigned markets or products, and ongoing development of labelling expertise
- Utilisation of analytical skills to review and develop appropriate content for local labelling documents, based on core content, also recording the decisions made
- Working within a framework of internal SOPs and working practices, and external regulatory requirements
- Supporting the use of relevant tools and technologies within the course of the label development and translation process
- Utilisation of regulatory expertise to review, develop and deliver core/local labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities
- Ensure that decisions taken for labelling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion.
Skills and Requirements
- Knowledge of global/regional regulatory regulations and guidelines pertaining to labelling, and/or general regulatory background/experience, potentially gained in a country office environment, is preferred.
- Ability to understand, analyse and propose information into local labelling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.