[Next Phase Solutions and Services, Inc. seeks a skilledBusiness Analystwith experience working on projects related to the Center for Drug Evaluation and Research (CDER) for the U.S. Food and Drug Administration (FDA).

**[Position Overview:

[As a Business Analyst, you will analyze business requirements, facilitate stakeholder meetings, and support project management activities. You will collaborate closely with cross-functional teams to ensure the successful delivery of projects related to pharmaceutical product evaluation and regulatory compliance.

**[Duties and Responsibilities:

[Conduct Requirements Analysis:[Collaborate with stakeholders to **elicit, analyze, and document business requirements for projects related to the Center for Drug Evaluation and Research (CDER). Translate business needs into clear and concise user stories, functional specifications, and system requirements.

[Facilitate Stakeholder Meetings[: **Organize and facilitate meetings, workshops, and focus groups with cross-functional teams and CDER stakeholders to gather requirements, define project scope, and obtain feedback. Foster open communication and collaboration to align business objectives and project deliverables.

**[Support Regulatory Compliance:[Ensure compliance with CDER regulations, guidelines, and best practices throughout the project lifecycle. Collaborate with regulatory affairs teams to understand and address regulatory requirements for pharmaceutical product evaluation, submission, and approval processes.

**[Perform Data Analysis:[Conduct data analysis and interpretation to support decision-making and inform business strategy. Utilize analytical tools and techniques to analyze quantitative and qualitative data related to drug evaluation, clinical trials, adverse events, and regulatory submissions.

**[Assist in System Testing:[Support the development and execution of test plans, user acceptance testing (UAT), and quality assurance (QA) processes for CDER-related systems and applications. Identify defects, discrepancies, and areas for improvement and collaborate with stakeholders to address them effectively.

**[Provide Training and Support:[Develop training materials and conduct training sessions to educate end users and stakeholders on CDER-related processes, systems, and tools. Provide ongoing support and troubleshooting assistance to ensure smooth implementation and adoption of new solutions.

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