Regulatory Data Migration Consultant

Proclinical have partnered with a large pharmaceutical company in search for a Regulatory Data Migration Consultant. This is a significant role that will transform the way it manages regulatory information. You will be expected to support the business data migration lead in executing the migration of all products, registration and process information from the old system to the new tool.

Job Responsibilities

• The migration will fall into 4 key stages, each one will build on the last and result in a final migration run which will have to meet the required quality standards
• There will be a sizeable remediation effort which will entail. Analysing the outputs of the previous data migration dry run and pursuing strategies to correct, complete or enrich this complex data set.
• Use of Excel to identify mismatches and missing data and working on the data to ensure that the subsequent iteration contains less errors, outliers and missing data by:
• Comparing data with that contained within approved regulatory documentation
• Following up with stakeholders to complete quality checks in line with the data remediation strategy
• Enriching the data as required with reference to approved documentation ( Quick to learn new data structures and their source or able to leverage existing experience with regulatory data)
• Able to use excel skills, reporting and other measures to identify new and efficient ways of reconciling data and comparing source and target values

Skills and Requirements

• 3+ years of experience in the pharmaceutical or similar industry, with specific experience related to large scale data migrations
• Ability to bring complex assignments through to completion
• Any knowledge of applicable standards such as IDMP, xEVMPD, MEDRA
• Expert user of Excel
• Tenacity and good interpersonal skills to retrieve and verify data, ability to work to tight deadlines and targets
• Experience of regulatory information management tools and techniques
• Ability to work with minimal direction and understand complex data relationships
• Understanding of data management principles and practices
• Understanding of GxP CSV documentation requirements for regulated systems

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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