Labelling Consultant - 6 month contract
An excellent opportunity has arisen for an experienced labelling consultant to join a growing team based in High Wycombe.
This is an urgent requirement and the ideal person will be able to join as soon as possible!
- Manage the development of updates to Company Core Data Sheets (CCDSs)
- Centralised/MRP EUPIs, and USPIs in accordance with GL CoE and GRA end-to-end labeling processes.
Qualifications experience and skills:
- Minimum of Bachelor's degree in a scientific discipline.
Advanced degree (MS, PharmD, PhD, or MD) desirable.
- At least 5 years' experience in the pharmaceutical industry or health authority, with at least 4 years' experience in regulatory affairs with experience associated with product labeling (prescribing and patient information).
- Product labeling experience should include authoring text for inclusion in CCDSs, EUPIs, and USPIs, including drafting text based on scientific source data, supporting rationale, regulatory requirements, standards, and templates, and liaison with subject matter experts and regulatory professionals.
- Advanced Microsoft Word skills.
- Experience working in a Documentum-based document management system.
- Basic Excel and PowerPoint skills.
- Excellent project management, verbal, and written communication skills.
For further details about this role or other vacancies within Regulatory Affairs please contact Tim Barratt on +44(0)1727 817 626 or send a copy of your CV to firstname.lastname@example.org
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