Senior Associate, Regulatory Data Quality Specialist

21 Aug 2019
20 Sep 2019
Sam Whyley-Smith
Full Time
Contract Type
Experience Level
Senior Management
Sam Whyley-Smith at CK Clinical is recruiting for a Senior Associate, Regulatory Data Quality Specialist to join a Global Pharmaceutical Company based in Hertfordshire on a permanent basis.

The Role:
The main purpose of the role will be to provide support, strategies and business solutions for the development and maintenance of regulatory systems. Establishing, managing and supporting regulatory systems according system requirements. The development of regulatory requirements and business and system support processes. Ensuring the integrity of the data either managed within the system or migrated from legacy systems. Use of QC processes and training end users for key tasks within the managed systems.

Main duties/responsibilities:
· Maintain the data integrity of data within the regulatory systems
· Ensure that Regulatory Information Systems are supported and managed according to business need and regulatory compliance
· Capture and implement system enhancements to optimise their operational capabilities according to business need
· Develop user requirements specifications for future information systems and create business justification for new systems
· Initiate UAT Scripts, deployment of software, design and deliver training for systems accordingly
· Stay current with industry best practice and software regards Regulatory Information Management, identifies opportunities to shorten approval timelines through enhanced knowledge sharing
· Engage with vendors and internal partners to drive future state of-the shelf software packages
· Ensure completeness of content contained in information management systems specifically as it relates to compliance

Your Background, Skills & Experience:
· College or University degree in an associated functional discipline (Chemistry or Pharmacy)
· Experience with Systems, in relation to document management and publishing is required.
· Knowledge of Regulatory and Submissions processes for EU, US and possibly ROW regions would be required.
· Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus.
· Experience in handling multiple tasks
· Knowledge of MS Office (Word, Excel, PowerPoint, Project), Adobe acrobat as well as being familiar with the use of multiple regulatory system applications

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46335 in all correspondence.