Pharma Business Analyst

Key Responsibilities

• Support of regulatory applications enhancements, escalated issues and GxP requirements.
• Work with stakeholders to elicit and validate use cases and requirements, both functional and non-functional for both waterfall and agile projects.
• Facilitate business requirements gathering process through best practices.
• Be able to elicit requirements and document them using multiple different requirements writing methodologies.
• Develop the necessary documentation for IT solution projects - e.g. project objectives & metrics, business requirements, use cases, functional specifications, deployment plans, systems & end-user documentation.
• Work with the technical teams to ensure that business requirements are understood so that plan, build and run can effectively deliver.
• Draws from experiences to develop solutions to complex problems that require a high degree of ingenuity, creativity and innovation within the boundaries of industry compliance regulation.
• Identifies and recommends business process improvements.
• Able to articulate complex technical problems and solutions to a wide business audience.
• Supports training deliverables for stakeholders and technical/functional software support experts during implementations and prototypes/pilots.
• Able to work independently, be self-motivated to accomplish tasks, and have great attention to detail.

Qualifications

• Thorough knowledge of GxP and 21 CFR Part 11 regulations and guidelines is required.
• Minimum of 3-5 years' experience as a business analyst within the pharmaceutical or biotech industry is required.
• Experience with regulated system projects, including requirements gathering, planning, execution, and deployment is required.
• Excellent communication skills are necessary- particularly organizing and presenting project information to management.
• Should be capable of multi-tasking across projects and highly organized.