Global Labelling Lead - Maidenhead, United Kingdom - Proclinical
Description
Proclinical are recruiting for a Global Labelling Lead to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.Responsibilities:
- Suggest the method to be followed in core labelling documents, guarantee to be in line with international regulatory methods.
- Supervise the execution of CDS updates in regional labels and oversee compliance to labelling procedures in a timely manner.
- Monitor the preparation of assisting documents for core labelling alterations, in cooperation with medical writing, guaranteeing alignment to the core labelling method and international regulatory tactic.
- Produce, preserve and update regulatory labelling processes and SOPs as well as assist with pertinent audits and inspections.
- Uphold expertise of present rules and guidelines managing international labelling actions.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a scientific or medically linked field would be ideal.
- Demonstrable experience working within a pharmaceutical/biotechnology organisation in regulatory, which involves international regulatory labelling, EU labelling and/or US labelling.
- Knowhow and comprehension of suitable guidelines, pharmacology, medicine, pharmacovigilance and drug development.
- Familiarity with document management and regulatory tracking systems.
- Capable of comprehending regulatory implications of product method with concerns to the product label, examination and practical management of affiliated impacts.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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Procurement&SupplyChain
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