PRA Health Sciences

Senior Regulatory Systems Specialist

United Kingdom
13 Jan 2021
12 Feb 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

PRA Health Sciences are an award winning CRO.

We are proud to have won Pharma Times ‘Clinical Research Company of the Year’ in 2017 for the fourth consecutive year. In December 2020 we were awarded ‘Best Company Culture’, ‘Best Company for Women’ and ‘Best Company for Diversity’. We aren’t winning these awards by chance; PRA is being recognised industry-wide for our dedication to the future of clinical development. Most importantly for you, at PRA we recognise that our success is down to our people.

As a Senior Regulatory Systems Specialist, you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors PRA’s commitment to career development.

As a Senior Regulatory Systems Specialist you will be responsible for executing data and document clean-up projects following a migration to a new Document Management System. You will also be responsible for:

  • Analysing data quality issues and defining the tasks required to remediate
  • Communicating and training the team on the remediation tasks
  • Overseeing the remediation activities of the team and reviewing their work
  • Updating document properties individually or using bulk update tools
  • Routing documents on review or approval workflows according to agreed processes
  • Identifying data quality issues for remediation and escalating for resolution

To be successful in this position you will need to have:

  • Regulated Pharmaceutical/CRO industry experience.
  • Substantial experience of regulatory document management systems (ideally DXC FirstDoc)
  • Excellent organizational, communication, and time management skills
  • Ability to work well with peers, clients, buyers and partners
  • Working knowledge of the software development life cycle and software development methodologies
  • Ability to learn new applications, processes and procedures of varying complexity

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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