GxP Business Analyst (Planisware)

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 a commercial software vendor in support of delivering a technical solution to meet the business objectives. The key activities for this position include:

· Collaborate with business SMEs to elicit and understand business requirements.

· Translate business to technical requirements. Document business processes and use cases.

· Write detailed, GxP-compliant SDLC - business requirements, use cases, As-Is and To-Be business flow diagrams, functional specifications, data requirements, and any other project-specific documentation. Gain approvals for documentation. Oversee organization of all project documents and ensure they are complete, current and archived properly.

· Assist the Validation Testing team with test script planning, preparation and execution.

· Create/update system management documentation.

· Work with the business areas to identify and prioritize system requirements throughout the duration of the project.

· Verbally present software functionality to business stakeholders and facilitate question and answer discussions. Demonstrate functionality using the systems.

· Support 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, 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, CFR 21 Part 11 and systems validation.

· Pharmaceutical or Biotech industry experience preferred.

Skills & Knowledge:

· Minimum 10+ years of experience in Pharmaceutical/Biotech industry – Clinical Development processes, study planning, forecasting and analytics preferred

· CRO services, SaaS vendors; IT Infrastructure operations

· Tools and Technologies: Planisware; simulation tools, SSO; VERA for ALM; MS Project and Office.

Education Requirements:

· BA or BS in Clinical Development Sciences or Life Sciences required.

· Advanced degree is strongly preferred

· CBAP is strongly preferred.