Submissions Publisher (Pharmaceuticals)

Recruiter
Red Eagle Recruitment Limited
Location
Sandwich
Salary
£25,040 per annum
Posted
01 Feb 2019
Closes
18 Feb 2019
Contract Type
Permanent
Hours
Full Time
Red Eagle Recruitment (AGY) is looking to recruit a Submissions Publisher for our client based in Sandwich. Our client is a research-based, global pharmaceutical company, which develops and manufactures vaccines and medicines. Working within a team to create Regulatory Agency Submission Packages (Dossier) using a number of 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 authorization approval for pharmaceutical products. Responsibilities include: 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 and assigning to resources available within India or Sandwich Support global/local teams publishing teams when the need arises Adhere to compliance standards. Prior Skills/Experience Preferred Proven technical aptitude Experience of using various publishing tools such as ISI Publisher and proven knowledge of eCTD formats 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 This is a 6 month fixed term contract, working 37 hours a week. Salary is £25,040 per annum. To find out more and to be considered for the role of Submissions Publisher, please apply via your CV. This job was originally posted as www.totaljobs.com/job/84737545

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