Job Description

Pay Rate: $65 - $72/Hour

The Sr. Business Analyst is responsible for eliciting and translating business requirements from internal customers into functional and non-functional requirements to be used by IT project teams and commercial software vendors in supporting the delivery of technical solutions to meet the business objectives.

The key activities for this position include:

• Collaborate with business SMEs to elicit business requirements. Translate business to technical requirements. Document business processes and use cases. Prioritize system requirements. Backlog grooming.
• Write detailed, GxP-compliant SDLC - business requirements, use cases, As-Is and To-Be business flow diagrams, functional specifications, integration and data requirements, and any other project-specific documentation. Oversee organization of project documents and ensure completeness.
• Assist the Validation Testing team with test script planning, preparation and execution.
• Create/update system management documentation.
• Present/demonstrate software functionality to business stakeholders and facilitate Q&A sessions.
• Support Production deployment and hypercare activities.
• Complete other ad hoc tasks, as requested.

Qualifications:

• Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.
• 10+ years' experience as a Sr. Business Analyst, with working command of requirements engineering, analysis techniques & tools. Highly experienced in SDLC & iterative systems development methodologies
• Product management - change and release management (ITIL), validation planning and execution
• Excellent oral and written communication skills; able to organize and clearly present ideas in a convincing and compelling manner.
• Diplomatic, results-driven interpersonal skills to gain understanding of requirements and priorities, manage stakeholder expectations, recognize non-verbal requirements and illuminate them, ask “Why?” to define business value.
• Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
• Ability to work on multiple projects in parallel.
• Familiarity with GxP, 21 CFR Part 11 and systems validation.
• Pharmaceutical or Biotech industry experience preferred.

Desired Skills & Knowledge:

Minimum 10+ years of experience in Pharmaceutical/Biotech industry – Clinical Development processes, project and portfolio management, forecasting and analytics preferred

CRO services, SaaS vendors; IT Infrastructure operations

Tools/Technologies:

MS Office, Planisware; Snowflake; simulation tools, Power BI; SSO; ALM VERA; JIRA; Veeva Vault eTMF(GxP) and MS Project.

Education Requirements:

• BA or BS in Clinical Development Sciences or Life Sciences required.
• Advanced degree is strongly preferred
• CBAP is strongly preferred.

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