Submissions Publisher

Red Eagle Recruitment (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.