Submissions Publisher (Pharmaceuticals)

Red Eagle Recruitment/Job & Talent (AGY) is looking to recruit a Submissions Publisher for our client, a global pharmaceutical manufacturer based in Sandwich, Kent. 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. Responsibilities: Responsible for the building, publishing and associated tasks for assigned Regulatory submissions within agreed timelines. Administrative activities such as tidying and reducing backlogs on the submission fileshares and maintenance of publishing systems 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 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 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. This is a 6 month fixed term contract, working 37 hours a week Monday to Friday. This is paying an hourly rate of £13 per hour To find out more and to be considered for the role of Submissions Publisher, please apply via your CV.