Business Analyst

Job #323
Business Analyst – U.S. Food and Drug Administration (FDA) experience required!
Next Phase Solutions and Services, Inc. seeks a skilledBusiness Analystwith experience working on projects related to 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 FDA related projects. 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 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 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 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 processes, systems, and tools. Provide ongoing support and troubleshooting assistance to ensure smooth implementation and adoption of new solutions.
Document Business Processes:Document current and future state business processes, workflows, and standard operating procedures (SOPs). Identify process improvement, automation, and optimization opportunities to enhance efficiency and effectiveness.
Stay Current on Industry Trends:Stay abreast of industry trends, regulatory changes, and best practices related to drug evaluation and regulatory affairs. Continuously expand knowledge and expertise in processes, guidelines, and requirements to support informed decision-making and drive business success.
Collaborate Cross-Functionally:Work collaboratively with internal and external stakeholders, including regulatory affairs, clinical research, quality assurance, and IT teams, to achieve project objectives and deliver high-quality solutions that meet business needs and regulatory requirements.

– Experience eliciting business requirements from business users and subject matter experts, and documents in various forms of technical documents anduser stories
– Proven experience working as a Business Analyst on FDA projects
– In-depth knowledge of FDA regulations, processes, and requirements
– Strong analytical skills with the ability to gather, analyze, and document complex business requirements
– Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders
– Experience with project management methodologies, tools, and techniques.
– Familiarity with software development lifecycle (SDLC) processes and methodologies
– Detail-oriented minds t with a focus on delivering high-quality results on time and within budget

Education

Bachelors degree in Computer Science (C.S.) or Software Engineering. Related fields (e.g., Engineering, Mathematics, Information Technology) may be relevant if the programs contain, at minimum, a concentration of courses in foundational C.S. areas.