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Skills Alliance Limited
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London, Greater London
Regulatory Affairs Data Manager
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Salary: £50000 - £60000 per annum, Benefits 15% Bonus + Benefit Package |
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Overview
A leading European specialist pharmaceutical company are currently recruiting a Regulatory Affairs Data Manager located just outside of North West London. The role requires a Regulatory Affairs Data Manager with oversee the day to day management of Regulatory Affairs Core Data, XEVMPD and IDMP data. In addition to maintain subject matter expertise regarding RA data legislation, guidelines and requirements. Responsibilities: Keep up to date on RA data legislation, including IDMP. Communicate changes to ensure RIMS Steering Committee and other key stakeholders are kept well informed of the impact to the company. Participate in industry forums on data legislation. Identify and anticipate impacts of changes to RA data legislation, including IDMP Act as a SPOR Super User for the company, ensuring that SPOR processes are followed and the companies data is kept up to date within SPOR Ensure controlled vocabularies and referentials are aligned within SPOR and applied consistently across RA systems. Ensure that changes are implemented according to best practise for data quality and standards. Provide RA data expertise in support of data governance policies at the company and carry out required data governance activities Provide subject matter expertise to support the creation of training and educational material and deliver initial training Create and maintain RA data management processes, procedures and work instructions. Support continuous improvement of data and processes, collecting feedback from users and acting as Veeva RIMS SuperUser Requirements: Bachelor’s degree in Computer Science, Business Administration, or related technical field or equivalent experience. Significant business systems / business process experience, with demonstrable experience in a regulatory affairs/Regulatory Operations/Clinical Operations environment. Experience in Manufacturing is desirable. In depth knowledge and understanding of pharmaceutical science processes and standards including XEVMPD, ISO IDMP, EMA SPOR, Pharmacopeia, Standard Terms/Referential, CMC and regulatory dossier lifecycle, MedDRA codes, etc. Deep understanding of the ISO IDMP data model and ability to interpret and articulate this model and legislative requirement to key stakeholders. Experience and understanding of the use of electronic data management systems, such as regulatory publishing systems, regulatory or clinical tracking databases, and ideally, also in manufacturing inventory systems This Regulatory affairs Data manager position is an office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package. Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on 44 (0) 207 220 6204 or click APPLY NOW This job was originally posted as www.totaljobs.com/job/89631989