Regulatory Submission Publisher
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| Job Type | Temporary / Contract |
| Location | Sandwich, Kent |
| Area | Kent, UK |
| Sector | Office Support |
| Salary | £12.00 to £17.00 per hour |
| Start Date | ASAP |
| Advertiser | Kim Williams |
| Telephone | 01372818299 |
| Job Ref | KW 11675 |
- Description
- Lloyd Recruitment Services are delighted to be recruiting for a long-standing pharmaceutical client who are seeking Regulatory Submission Publisher.
Please note: this role is being offered on a temporary 12-month basis (paid week by week).
This role works within a team to create Regulatory Agency Submission Packages (Dossier) using build and publishing tools. The Dossiers are compiled in paper and/or electronic format with documentation received from Hub Submission Managers and submitted to Regulatory agencies (often within very tight timelines) to seek clinical trial and/or marketing authorisation approval for pharmaceutical products.
Major Duties
Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.
Adhering to quality control procedures and standards related to submission publishing.
Adhering to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps to ensure Regulatory compliance.
Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
Responsible for key projects within a specific region to implement and train on any external agency updates for procedures or requirements
Responsible for leading major submissions. Coordinating the allocation of all publishing activities around the global publishing hubs to meet agreed deadlines, whilst tracking and monitoring all issues.
Liaising with Global Submission Managers, Hub Submission Managers and contributing lines to discuss and agree expectations and publishing timelines.
Monitoring local mailbox for any urgent publishing requests
Support global/local publishing teams when the need arises
Adhere to compliance standards
Training and Education Preferred
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
Functional and technical knowledge and skills to do the job at a high level of accomplishment
Prior Skills/Experience Preferred
Proven technical aptitude
Experience of using publishing tools such as Liquent InSight and proven knowledge of eCTD formats would be preferred
Quick learner with ability to multi-task
Ability to work with accuracy and attention to detail
Ability to work with autonomy and/or part of a team in a busy environment
Demonstrated ability to work in a highly regulated environment
Demonstration of experience working in a customer service environment
All offers are subject to security screening checks, which includes Employment, CCJ and DBS checks
NB: Unfortunately, due to the high level of applications received by Lloyd Recruitment Services, we are only able to contact shortlisted.
