Regulatory Submissions Publisher

Job Ref: J33223
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 23 August 2019
  • Kent, England, UK Kent Kent UK CT13 9NJ
  • Competitive
    HOUR
  • Natasha Rollason
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SRG are recruiting on behalf of a Global Pharmaceutical Company who have opened a new vacancy and are looking to recruit a Regulatory Submissions Publisher on an initial 6 Month contract to be based at their offices in Kent.

Responsibilities:

  • Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.
  • Adhere to quality control procedures and standards related to submission publishing.
  • Adhere 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.
  • Liaise with Global Submission Managers, Hub Submission Managers and contributing lines to discuss and agree expectations and publishing timelines.
  • Monitor local mailbox for any urgent publishing requests.
  • Support global/local publishing teams when the need arises
  • Adhere to compliance standards

Education/Skills:

  • Degree minimum in any Life Sciences
  • 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
  • Proven technical aptitude
  • Experience of using publishing tools such as Liquent InSight 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

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@SRG.co.uk or +441753 589673

SRG
22/09/2019 11:30:49
GBP