Vacancy caducado!
Role: Principal IS Business Systems Analyst Description - Project will be supporting data integrations with Veeva vault. Experience in publishing tools and the publishing space, Veeva Vault is highly recommended. Having a regulated background would be helpful (not a must have). Need to hold vendor accountable for the design, and deliverables in this space. AWS components will be used and is a nice to have. Having SaaS technical and functional experience is required, and have worked with developers, Quality, validation processes in a GxP (full set of documentation) regulatory pharma environment is needed.
Responsibilities:- 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
- Deep experience working in a technology capacity with business stakeholders
- Prior experience and strong knowledge of global pharmaceutical regulations, regulatory submissions and regulatory publishing process.
- Outstanding written and verbal communication skills
- 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, including data analysis.
- Sharp learning agility, problem solving and analytical thinking
- Experience in computer systems validation, GxP, and FDA 21 CFR Part 11
- Familiarity with Veeva Vault RIM
- Knowledge of DevOps, Continuous Delivery, and Agile product development
Vacancy caducado!