Labeling Project Manager
|Job Title:||Labeling Project Manager|
|Location:||South East England,|
|Contact Name:||Catherine West|
|Job Published:||February 01, 2017 08:16|
I am currently exclusively working with a client who is looking for a Hub Labelling Project Manager. This contract role is based in South East England for a 6 month initial contract.
They are looking for someone with at least a year in the pharmaceutical industry, with PM experience in a global context.
The role will require the candidate to act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence. Additionally, this role will support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries.
Key activities include:
- Project management support for global initiatives in line with assigned responsibilities and working to timeframes defined by the project team
- Utilisation of analytical skills to review and develop appropriate content for local labeling documents, based on core content, also recording the decisions made
- Working within a framework of internal SOPs and working practices, and external regulatory requirements
- 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 utilized within role.
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