Regulatory Affairs Application Support Business Analyst
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Proclinical are recruiting a Regulatory Affairs Application Support Business Analyst for a biotech organisation. This role is on a permanent basis and is located in Frankfurt.
- Responsible for offering application assistance to crucial users for the eDMS, RIMS and eSM platforms, such as business functional operations, high-level data analytics, data management, change management, etc.
- Produce and uphold all necessary user requirement specifications and quality control documents when needed by SOPs and procedures.
- You will federate the user community engaging on new regulatory alterations being executed within the eDMS, RIMS and eSM systems, leading business operations impact assessments and any other industry best practices execution.
- Assist with the system data management actions, such as master data management, data quality, security and integrity, preparation and execution of data-connected alterations.
- The ideal candidate will analyse, handle and align solution releases, such as process and data needs, the design, test scripts writing and implementation.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a scientific field, such as computer science/information systems, engineering, mathematics, natural sciences, medical, or biomedical science.
- Know-how of systems in the regulatory affairs domain, which involves Regulatory Information Management, electronic Document Management and publishing mgmt. systems, with exhibited familiarity in handling assistance and demand requirements for these systems.
- Expertise on regulatory affairs business domain and GRA business procedures and data management.
- Capable of comprehending multifaceted functional needs/requests from business users translate them into pragmatic and workable technology solutions.
- Acquaintance with regulatory data standards such as IDMP/XEVMPD.
- An agile process management mindset with the ability to be customer focused.
If you are having difficulty in applying or if you have any questions, please contact Sheridon Lloyd on +41 61 563 1243.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.