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 ; liaise with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
- 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 across regions, requesting medical advice from others when appropriate.
- Engagement in necessary labelling team meetings to discuss any decisions for not making any label updates or discuss any findings of meaningful differences for registration types specific to USPIs, CRP-SmPCs and MRP/DCP-SmPCs as necessary.
- 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.
- Ensure all actions taken within role follow applicable SOPs and IGs so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labelling projects via defined procedures and optimal use of systems. Champion and/or participate in continuous improvement efforts related to business practices and tools utilised within role.
- For deliverables in scope, support responses to inquiries from client colleagues in
response to inspection activities and regulatory agency questions.
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.