Description
Our client is seeking a Specialist IS Business Systems Analyst (Senior Business Analyst) for an 8 month contract to support a critical, compliance driven project in the Clinical and Regulatory space.
For this role you must have Pharma Regulatory experience, this is essential.
The role has been scoped INSIDE of IR35 and is remote working with the occasional visit to client site.
Key experience:
- Serve as a client facing partner working with business and IS stakeholders to implement and support business systems that achieve project objectives
- Responsibilities include process and systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, developing and communicating business cases for proposed solutions, and serving as the lead business analyst throughout and post implementation
- Engage with key vendors and platform owners to understand functionality and how those platforms can be leveraged to tackle project problems
- Meet regulatory requirements and adhere to IS standards including following GxP Quality processes
Additional qualifications:
- Deep experience working in an IS capacity with business stakeholders
- Prior experience and strong knowledge of European Pharmaceutical Regulations, particularly for Clinical Trials.
- Ability to explain complex technical concepts to non-technical clients
- Possess analytical skills and techniques to evaluate, interpret and resolve complex situations/problems using multiple sources of information
Preferred Qualifications:
- Solid understanding of Veeva Vault RIM or other Veeva Vault products
- Knowledge of DevOps, Continuous Delivery, and Agile product development
- Experience in computer systems validation, GCP, and FDA 21 CFR Part 11
Due to the volume of applications received for positions, it will not be possible to respond to all applications and only applicants who are considered suitable for interview will be contacted.
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