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Job Details

Hub Labelling Manager - Surrey

Company: CK Clinical
Location: Surrey
Reference: CL41158
Closing Date: 06 Mar 18
Type: Contract
Salary (£): Negotiable

Job Summary:

Mary Bolt is recruiting for a Labelling Manager to join a leading, innovative biopharmaceutical company at their site based in Surrey on a contract basis....


Mary Bolt is recruiting for a Labelling Manager to join a leading, innovative biopharmaceutical company at their site based in Surrey on a contract basis.

The main purpose of the role will be to:
-Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence as well as interacting 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 and present information in an optimal format and level of information for that audience.
-Develop subject matter expertise for assigned markets/products and ongoing development of labelling expertise and utilise analytical skills to review and develop appropriate content for local labelling documents, based on core content.

Further responsibilities will include:
-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.
-Ensuring 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 as well as following applicable SOPs and IGs so that high quality delivery of outputs and compliance is maintained and championing/participating in continuous improvement efforts.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in life science or a related field with experience of working within labelling in Regulatory Affairs and knowledge of global/regional regulations and guidelines.
-The 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.
-Excellent project management skills, the ability to plan and prioritise, working within specific deadlines and strong written and verbal communication skills.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41158 in all correspondence.

Apply for this job: Hub Labelling Manager - Surrey

Contact Information:

Address:  Head Office
9 High Street
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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