Description
Senior Regulatory Publisher - Global Pharmaceutical - FDA Experience - up to £50,000 + 20% bonus + home workingSenior Regulatory Publisher - Global Pharmaceutical - FDA Experience - up to £50,000 + 20% bonus + home working
We are currently looking for a Senior Regulatory Publisher to work on behalf of a leading global pharmaceutical company based in the South East of England. Your role will involve some hands on publishing as well as acting as an advisor to clients and other team members. You will be involved with training other members of staff and there is definite opportunity to move into management further down the line.
Key Skills/Experience
- You MUST have experience working with the FDA
- At least 2 - 5 years experience working in publishing of electronic (eCTD/NeeS) and paper submissions (Ideally 5+ years)
- Commercial awareness
- Experience of working in operational publishing teams
- Extensive knowledge of ICH/US FDA regional submission guidelines
- Compliance checking, Hyper-linking , bookmarking, QC/ review of documents, Rendering Multiple documents to PDF, Creation of external links , Compilation/Publishing of Modules 1-5 in electronic and paper formats, QC/review of dossier & Validation
- Experience in Documentum-based dossier repositories.
- Good working knowledge of eCTDXpress, ISIPublisher, Adobe Acrobat, ISIToolbox, Compose.
- Ability to prioritise and multitask
The company offer a great benefits package and the opportunity to progress into management. They are looking for someone who is self motivated, proactive and has the ability to prioritise and multitask. Someone who has excellent communication skills and strong commercial awareness would be desirable.
If this is of interest to you and you would like to find out more information on this position or any other regulatory affairs positions, please contact Amanda Edwards on or please email a.edwards(a)realstaffing.com
To find out more about Real please visit www.realstaffing.com