Job Description
* To work closely with the Line Manager to ensure completion of tasks within agreed time lines
* Provide updates to key stakeholders on variations/ new marketing authorisation applications, as directed, in line with SOP's and WI's
* Monitor team inboxes
* Provide general support for business tasks such as couriers, scanning, archiving, letters, presentations, spreadsheets and general filing
* Administrative support and management of documents in the Document Management System
* Provision of SmPC as requested by Pharmacovigilance
* Ensure that paper and electronic files are up to date and maintained in accordance with procedures
* Identify and escalate areas of administrative process improvement
* Accurately updating regulatory information systems following updates
* Running reports to extract data from the regulatory information systems
* Provide support to the UK/IE RA team for all projects which include specific documentation requests
* Proof reading of mock-ups ensuring compliance at all times
* Providing adhoc support to requests from various department functions
* Other duties as required at the direction of senior Regulatory Affairs personnel.
Required Knowledge, Skills, and Abilities
Qualifications:
* School education essential
Experience:
* Ideally experience in the Pharmaceutical Industry, or other regulated environment
Knowledge:
* Basic understanding of processes and departments within a pharmaceutical company
* Microsoft Word, Excel and Outlook
Skills:
* Excellent oral and written communication
* Ability to work under pressure and to tight time deadlines
* Effective time and organisation management
* Being able to work under your own Initiative and as part of a team.
* Computer literacy
Reference no: 100029