Role: Regulatory Business Analyst

Visa-USC, GC

Location-Tarrytown, NY(Onsite)

Essential Job Functions:

· Able to work independently with little or no guidance.

· Author SDLC Documentation such as requirements specification for the implementation of a cloud-based solution where the gathering of requirements is conducted in-line with configuration workshops.

· Work with Project team to gather all relevant information.

· Help with Service now request and change control

· Understanding of change management process.

· Organize and host requirements session with the end users and facilitate to reach consensus on requirements/business goals.

· Translate vague / high level business requirements into verifiable data models / system functionalities / specifications.

· Create requirements/design documents with attention to details, always maintain their accuracy and correctness.

· Be creative when communicating to end users and facilitate their understanding in complicated software design and solution using diagrams, charts, and data flows and other visual aids.

· Plan and facilitate entire UAT activities by preparing documentation (Test Plan, schedule, participants, scenario, and test cases) and driving till the UAT sign-off.

· Participate in regular meeting.

· Work flexibly with dynamic environment were priority changes frequently.

· Conduct system testing in lower environment and validate implemented solution with structured testing.

· Adhere and follow standard protocols including Change Management, and other administrative/governance standards and procedures.

· Responsible for document and distribution of meeting notes/minutes

· Support the organization and manage of project collaboration portal and deliverables

· Actively facilitate the entry and progress of the project RAID log

Experience:

· Minimum 10 years of experience working in a pharmaceutical environment as a business/system analyst.

· Experience in Veeva Vault RIM.

· Experience of System Development Life Cycle and GxP validation

· Knowledge of the Pharmaceutical Registration process

Required Skills/Abilities:

· Experience working on an enterprise solution implementation as Business/System analyst.

· Work experience with a formal release management, change management, versioning and build process enforced at an institutional level.

· Excellent oral and written communication skills and the ability to articulate highly technical topics to non-technical stakeholders.

· Excel at organizing and managing own tasks, deliverables, meeting minutes, presentations, and other documentation/communications.

· Expert level competency using standard productivity tools specifically MS Visio/MS Excel/MS PowerPoint with diagrams/charts and other visual aids to document technical details such as system flow/architecture/dataflow.

· Reasonable hours to east coast time zone.

Job Types: Full-time, Contract

Pay: $54,403.39 - $150,000.00 per year

Experience level:

• 9 years

Application Question(s):

• Note: This is an onsite opportunity @ Tarrytown, NY.

May I know your visa status and comfortable going onsite?

Experience:

• pharmaceutical environment as a business/system analyst.: 10 years (Required)
• Pharmaceutical Registration process: 2 years (Required)
• Veeva Vault RIM: 2 years (Required)
• GxP validation: 2 years (Required)

Work Location: In person

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