323 - Business Analyst - (CDER/FDA) Experience Required

Description

U.S. Food and Drug Administration (FDA) experience required!

U.S. Food and Drug Administration (FDA).

Position Overview:

Duties and Responsibilities:

Conduct Requirements Analysis:

 Collaborate with stakeholders to

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.

General 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

Additional Information about this opening:

• Employees of Next Phase shall, as an enduring obligation throughout their term of employment, adhere to all information security requirements as documented in company policies and procedures
• Enjoy the flexibility of a hybrid work environment, with three days in the office per week (Tuesday, Thursday, and Friday) and two days working remotely
• We are committed to your professional growth, providing opportunities for advancement and exposure to exciting projects and initiatives
• This position is suited for candidates within commuting distance to Columbia, MD and not eligible for a fully remote schedule
• As a healthcare and science research company, Next Phase embraces the recommendations from the CDC regarding vaccines for highly infectious diseases. Unless qualified for a religious or medical exemption, employees are required to be vaccinated against COVID-19.
• We offer a competitive salary, a comprehensive benefits package, and professional growth and development opportunities. If you meet the above requirements and are looking for a challenging and rewarding career opportunity, please submit your application for consideration.
• The pay range for this job level is a general guideline only, not a compensation or salary guarantee. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, abilities, internal equity, alignment with market data, applicable bargaining agreement (if any), or other laws.

ABOUT NEXT PHASE SOLUTIONS AND SERVICES, INC.

Innovation. It’s What Defines Us.

Will you join us to share in the success?

Benefits

HEALTH AND WELLNESS BENEFITS

• Choose from three medical healthcare plans.
• Dental and Vision Insurance plans.
• Enjoy a Flexible Spending Account (FSA) and Health Savings Account (HSA), and a company-sponsored Wellness Program.

PERSONAL INSURANCE BENEFITS

• Next Phase offers life insurance, accidental death, and dismemberment (AD&D) insurance, as well as short-term and long-term disability insurance, all of which are paid for by the company.

PAID LEAVE

• Employees receive competitive paid time off, including 11 holidays and maternity leave for recovering mothers.

RETIREMENT

• Next Phase contributes 5% to a 401K plan without requiring employee contributions.

PROFESSIONAL DEVELOPMENT

• Employees can be reimbursed for professional development expenses such as classes, books, technical certification/testing fees, professional dues/subscriptions, and professional licenses required for their position.

PET INSURANCE

• You have two options to ensure the happiness and health of your pets.

COMPETITIVE BONUS PROGRAM

• At Next Phase, we believe in sharing our success with the employees who make it happen!

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”

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

.