Business Analyst

5 days ago

Columbia, Maryland, United States Next Phase Solutions and Services, Inc. Full time
Job Description

Job Summary:

We are seeking a highly skilled Business Analyst with experience working on projects related to the Center for Drug Evaluation and Research (CDER) for the U.S. Food and Drug Administration (FDA). As a Business Analyst, you will analyze business requirements, facilitate stakeholder meetings, and support project management activities.

Key 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.
  • Document Business Processes: Document current and future state business processes, workflows, and standard operating procedures (SOPs) related to CDER activities. 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 CDER 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.

Requirements:

  • Three (3) years of proven experience eliciting business requirements from business users, and subject matter experts, and documents in various forms of technical documents and user stories.
  • Proven experience working as a Business Analyst on FDA projects (CDER-related preferred).
  • 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 mindset with a focus on delivering high-quality results on time and within budget.

Education:

  • Bachelor's 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.

Additional Requirements:

  • Strong organizational and communication skills.
  • Ability to manage multiple tasks and prioritize workload based on the needs of the client.
  • Ability to deal with ambiguity and frequent changes in priorities.
  • Ability to work with minimal supervision.
  • Excellent technical writing skills and proven experience in systems with complex requirements.
  • Excellent teamwork and interpersonal skills with the ability to team with others to meet project objectives.
  • Understanding of the system development lifecycle as implemented with Agile; SAFe knowledge a plus.

Physical Requirements:

  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to navigate in an office setting unassisted.
  • Must be able to lift up to 10 pounds.
  • Strong speaking skills, including the ability to articulate thoughts in a clear manner and excellent word enunciation skills are required.

  • Lead Business Analyst

    2 weeks ago

    Columbia, Maryland, United States Cogent People Inc Full time

    Cogent People Inc - Lead Business AnalystCogent People Inc is seeking a skilled Lead Business Analyst to enhance our team within the Healthcare industry. In this pivotal role, you will be instrumental in engaging with clients to extract business needs, interpret data, and guide fellow analysts in the organization.Work Arrangement: Hybrid (in-office presence...

  • Business Systems Analyst

    2 weeks ago

    Columbia, Maryland, United States Global Alliant Inc Full time

    Position: IT Business AnalystLocation: Washington DCRole Overview:The IT Business Analyst will be responsible for evaluating and enhancing business operations. This role involves anticipating organizational needs, identifying opportunities for improvement, and implementing effective solutions.Key Responsibilities:Assessing current business processes and...

  • Business Controls Analyst

    23 hours ago

    Columbia, Maryland, United States Freedom Mortgage Full time

    Job SummaryWe are seeking a highly skilled Business Controls Analyst to join our team at Freedom Mortgage. As a Business Controls Analyst, you will play a critical role in ensuring the effective execution of various processes within our Default Business Controls team.Key ResponsibilitiesProcess Management: Manage inbound and outbound service transfers,...

  • Business Development Analyst Intern

    5 days ago

    Columbia, Maryland, United States Rekor Systems Inc Full time

    Job DescriptionRekor Systems, Inc., a leading provider of intelligent infrastructure solutions, is seeking a highly motivated and analytical Business Analyst Fall Intern to join our team. As a trusted global authority in traffic management, public safety, and commercial markets, we collect, connect, and organize the world's mobility data to deliver...

  • CRM Business Analyst

    7 days ago

    Columbia, Maryland, United States Howard Community College Full time

    Job SummaryWe are seeking a highly skilled CRM Business Analyst to join our Enrollment Services team at Howard Community College. As a key member of our team, you will be responsible for managing the administration, maintenance, and support of our CRM platform, providing expert-level knowledge and guidance to our staff and stakeholders.Key...

  • Senior NETSS Functional Analyst

    1 week ago

    Columbia, Maryland, United States GCOM Information Technology Inc Full time

    NETSS Functional Analyst SMEGCOM Information Technology Inc is seeking a highly skilled NETSS Functional Analyst SME with a robust background in the software development lifecycle and NETSS functionalities. The successful candidate will possess a Bachelor's or Master's degree in Computer Science, Information Systems, Engineering, Mathematics, Business, or a...

  • Investment Analyst

    2 weeks ago

    Columbia, Maryland, United States Ames Watson Full time

    About Ames WatsonAmes Watson is a privately owned diversified operating entity that acquires, transforms, and collaborates with mid-market firms to generate sustainable value. Our approach goes beyond mere capital infusion; we provide expertise, problem-solving capabilities, extensive resources, and experience to foster growth and help businesses navigate...

  • Senior NETSS Functional Analyst

    1 week ago

    Columbia, Maryland, United States GCOM Information Technology Inc Full time

    NETSS Functional Analyst Subject Matter ExpertGCOM Information Technology Inc is seeking a NETSS Functional Analyst Subject Matter Expert with a robust background in the software development lifecycle and specialized knowledge in NETSS functionalities. The successful candidate will possess a Bachelor's or Master's degree in fields such as Computer Science,...

  • Senior NETSS Functional Analyst

    2 weeks ago

    Columbia, Maryland, United States GCOM Information Technology Inc Full time

    NETSS Functional Analyst Subject Matter ExpertGCOM Information Technology Inc is seeking a NETSS Functional Analyst Subject Matter Expert with a profound understanding of the software development lifecycle and NETSS functionalities. The successful candidate will possess a Bachelor's or Master's degree in fields such as Computer Science, Information Systems,...

  • Healthcare Integration Analyst

    2 weeks ago

    Columbia, Maryland, United States Dexian Full time

    Position: Integration Business AnalystEmployment Type: Full-TimeOverviewWe are in search of a skilled Business Analyst to become a vital part of our Technical Operations division. This role is essential for the establishment of B2B interfaces, facilitating the growth into new practices and diverse business scenarios.Key ResponsibilitiesDocument the...

  • Signals Analyst

    5 days ago

    Columbia, Maryland, United States DCCA Full time

    About DCCADCCA is a veteran-owned IT business specializing in providing innovative solutions to a variety of government agencies and commercial enterprises since 1982. As a trusted partner, we offer career growth opportunities and a competitive compensation and benefits package.Job SummaryWe are seeking a skilled Signals Analyst to join our team. The ideal...

  • Cultural Insights Analyst

    2 weeks ago

    Columbia, Maryland, United States Global Dimensions Full time

    Company Overview:Global Dimensions is a HUBZone, service-disabled, veteran-owned small business dedicated to providing exceptional services in various fields including language and culture, training and education, IT, cyber security, and intelligence analysis.Position Summary:We are currently looking for a Cultural Insights Analyst specializing in CI/HUMINT...

  • **Signals Intelligence Analyst**

    7 days ago

    Columbia, Maryland, United States DCCA Full time

    About DCCADCCA is a veteran-owned IT business that specializes in providing innovative solutions to government agencies and commercial enterprises. With over 40 years of experience, we have established ourselves as a trusted partner in the industry.Job SummaryWe are seeking a highly skilled **Signals Intelligence Analyst** to join our team. As a key member...

  • Financial Project Analyst

    1 week ago

    Columbia, Maryland, United States Insight Global Full time

    Position OverviewInsight Global is looking for a Project Financial Analyst to contribute to our operations. The ideal candidate will possess strong analytical skills and a solid understanding of Government Contracting.Key ResponsibilitiesSupport the Director of Finance, Program Management, and Executive Management in overseeing assigned programs.Manage...

  • EVM Financial Operations Analyst

    2 weeks ago

    Columbia, Maryland, United States Insight Global Full time

    Position OverviewInsight Global is in search of a skilled Financial Analyst to contribute to our financial operations. The ideal candidate will possess a comprehensive understanding of finance, accounting, and business methodologies.Key ResponsibilitiesSupport Financial Leadership: Assist the Director of Finance and Program Management in overseeing program...

  • Senior Compliance Analyst, Licensing

    2 weeks ago

    Columbia, Maryland, United States Adtalem Global Education Full time

    Company OverviewAbout Adtalem Global EducationAdtalem Global Education stands as a prominent entity in the realm of post-secondary education, recognized for its commitment to delivering professional talent to the healthcare sector. Our mission is to educate and empower students, equipping them with the essential knowledge and skills to emerge as leaders...

  • Sustainability Program Analyst

    2 weeks ago

    Columbia, Maryland, United States ICF International Inc Full time

    Sustainability Program Analyst, Operations (Hybrid) Location - Remote and Office-Based Are you prepared to drive impactful change? Are you passionate about supporting innovative Utility Programs and Services? As a key contributor to the Maryland Operations team, you will engage in the creation of high-quality deliverables while collaborating with a diverse...

  • Energy Analyst Internship Opportunity

    18 hours ago

    Columbia, Maryland, United States ICF International Inc Full time

    About the RoleWe are seeking a highly motivated and detail-oriented intern to join our Energy Efficiency Division at ICF International Inc. As an Energy Analyst Intern, you will have the opportunity to contribute to the development of innovative and high-quality products and services.Key ResponsibilitiesAssist in data collection and analysis to support...

  • Senior Threat Intelligence Analyst

    1 week ago

    Columbia, Maryland, United States Lumen Technologies Full time

    About LumenLumen connects the globe, driving business expansion by linking individuals, data, and applications seamlessly and securely. We are cultivating a culture and organization rooted in teamwork, trust, and transparency. Our people are the catalyst for progress.Commitment to InclusionLumen's dedication to workplace diversity and employee support is...

  • Senior Threat Intelligence Analyst

    2 weeks ago

    Columbia, Maryland, United States Lumen Technologies Full time

    About LumenLumen connects the globe, driving business advancement by linking individuals, data, and applications in a swift, secure, and seamless manner. We are fostering a culture and organization built on collaboration, trust, and transparency. Our workforce is the catalyst for progress.Commitment to InclusionLumen's dedication to workplace diversity and...