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323 - Business Analyst (CDER)
Next Phase Solutions and Services, Inc. seeks a 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).
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.
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.
Education
If you are a talented Business Analyst with experience working on FDA/CDER projects and are passionate about making a positive impact in the pharmaceutical industry, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter outlining your relevant experience and qualifications.
General Requirements:
Physical Requirements:
Additional Information about this opening:
ABOUT NEXT PHASE SOLUTIONS AND SERVICES, INC.
Innovation. It’s What Defines Us.
Next Phase Solutions and Services, Inc. provides insights and solutions for healthcare, engineering, and science research. Next Phase commits to creating an environment where our employees achieve their full potential, increase productivity, and expand their professional and personal horizons. We look for bright, innovative people who achieve results, understand the importance of being productive and supportive team members, and prioritize customer satisfaction. Next Phase leadership is looking for new leaders, scientific and technical subject matter experts, and technically savvy people interested in putting forth the effort and commitment needed to grow our company.
Will you join us to share in the success?
Benefits include, but are not limited to:
HEALTH AND WELLNESS BENEFITS
PERSONAL INSURANCE BENEFITS
PAID LEAVE
RETIREMENT
PROFESSIONAL DEVELOPMENT
PET INSURANCE
COMPETITIVE BONUS PROGRAM
Next Phase Solutions and Services, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
"EOE, including disability/vets"
“APPLICANTS HAVE RIGHTS UNDER FEDERAL EMPLOYMENT LAWS”
KNOW YOUR RIGHTS: WORKPLACE DISCRIMINATION IS ILLEGAL
FAMILY AND MEDICAL LEAVE ACT (FMLA)
PAY TRANSPARENCY
EMPLOYEE RIGHTS EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER USERRA
JOB SAFETY AND HEALTH: IT'S THE LAW!
EMPLOYEE RIGHTS UNDER THE FAIR LABOR STANDARDS ACT
NEED ASSISTANCE?
If you are a person with a disability requiring assistance with the electronic submission process, please contact us at HRDirector@npss-inc.com.
Our ADA Process Steps include:
1. Initiate Communication:
Our dedicated HR representatives promptly reach out to applicants to discuss their specific needs and explore how we can support them throughout the application process.
2. Offer Reasonable Accommodations:
Our HR team asks about the nature of assistance needed, ensuring we are ready to provide reasonable accommodations that enable applicants to complete the electronic submission process comfortably.
3. Engage in an Interactive Process:
We engage in open and effective communication with individuals, seeking to understand their limitations and unique requirements.
4. Document the Interaction:
We maintain detailed records of communication and any accommodations provided, ensuring compliance with the ADA and facilitating future inquiries or audits. All documentation is treated confidentially.
5. Ensure Confidentiality:
We prioritize the confidentiality of information related to an applicant's disability, sharing it only with individuals who have a legitimate need to know, such as those involved in providing accommodations.
6. Provide Assistance as Needed:
Based on the applicant's information, our HR representatives offer assistance tailored to accommodate individual disabilities, whether it be additional time, alternative formats, or other reasonable adjustments.
7. Educate Staff:
Our HR staff and relevant personnel are well-versed in ADA requirements and our commitment to providing reasonable accommodations. We provide ongoing training to ensure our team responds appropriately to similar requests, fostering an inclusive and supportive environment.
Full Time
IT Outsourcing & Consulting
$97k-117k (estimate)
04/04/2024
06/03/2024
npss-inc.com
COLUMBIA, MD
25 - 50
2010
JASON HEAVENER
<$5M
IT Outsourcing & Consulting
Next Phase Solutions and Services (Next Phase) is rethinking problem solving. We are a consulting and technology services firm providing insight and solutions for Health IT, Science Mission Support and Engineering. Our technical solutions and expertise in healthcare informatics/statistical analysis improve the understanding of the nation's challenges surrounding health care costs, quality and patient safety. Our software systems improve insight into fraud, waste and abuse in major federal healthcare programs, and our identity management experts develop systems to securely exchange private heal...th and personal data. Our engineering services support next generation space systems development, science data analysis and research in the areas of earth and space science. Next Phase is an 8(a) certified, HUBZone, Woman-owned small business. We are experts in Agile software delivery and are appraised as a CMMI for Dev Level 3 company.
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The job skills required for 323 - Business Analyst (CDER) include Business Requirements, Project Management, Initiative, Computer Science, Futures, Leadership, etc. Having related job skills and expertise will give you an advantage when applying to be a 323 - Business Analyst (CDER). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by 323 - Business Analyst (CDER). Select any job title you are interested in and start to search job requirements.
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