Job description Posted 20 November 2019

Clinical Trial Application (CTA) Submission Support
GSK Stockley Park
6 Month Contract
Pay: up to £27 per hour (PAYE)

Job Purpose

The Job holder works with the Clinical Study Support Team Manager to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK processes and policies as they apply to the role.

Key Responsibilities

  • Responsible for development & refinement of the CTA lifecycle strategy and implementation of submissions.
  • Coordination of CTA lifecycle submissions to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures
  • Accountable to the Clinical Study Support Team Manager for overall work plans.
  • Accountability for agreed tasks and projects.
  • Ensure independent communication, with a range of internal GSK staff, in support achievement of the assigned goals.
  • Ensure compliance with GSK CTA and maintenance process through timely action and completion of records in internal GSK systems
  • Ensure quality of own work to agreed timeframes, including compliance with GSK systems and record keeping.
  • May provide additional support to Project Cleo

Educational Background

  • Biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
  • Scientific or Regulatory Affairs (CTAs) background

Job-Related Experience

  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • A good understanding of Clinical Trial Directive and CTA submission requirements for multiple countries/submission types
  • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to interpret and advise on guidelines and requirements on a global basis
  • Ability to build effective working relationships and work in a matrix environment effectively
  • Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
  • Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Additional information about the process

All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.