Regulatory Systems Business Analyst

IT Business Analyst, Regulatory Systems

Duration: 18-24 Months with possible extension

Location: Remote

Pay Rate:$70.00/hr on W2

Summary

Join our client's Information Technology team as an experienced Business Analyst specializing in Regulatory Systems. In this role, you will be responsible for all aspects of computer systems related to Regulatory. Acting as a subject matter expert, you will serve as a valuable resource for regulatory information management systems. Reporting to the Associate Director of Business Technology for Regulatory systems, you will play a crucial role in ensuring efficient and compliant regulatory processes.

Responsibilities

As a Business Analyst, your responsibilities will include:

Functional Expertise: Utilize your in-depth knowledge of Regulatory Information Management (RIM) Systems to provide expertise and guidance.

Solution Development: Collaborate with clients to identify, evaluate, and improve systems and procedures to meet business needs.

Strong Partnerships: Build and maintain strong relationships with clients and vendors to ensure seamless collaboration and effective project implementation.

Project Management: Participate in complex projects, effectively managing and communicating risks. Additionally, you may have the opportunity to lead project teams.

Requirements Gathering: Collect and document user, functional, and technical requirements for regulatory information management systems in the vaccines biologics business space.

Strategic Insight: Contribute to the development of business cases, evaluate opportunities for process and technology improvements, and provide input for long-term strategic roadmaps.

Configuration Management: Manage application configuration changes following IT Change Management and GxP Change Control procedures.

System Validation and Support: Participate in system validation, release, and post-deployment support activities, working closely with Quality, Validation, System Owners, and IT Operations.

Application Support: Provide application support for validated systems, interacting with end users to understand their needs and offering technical guidance and training.

Troubleshooting and Resolution: Troubleshoot technical issues and manage problems through to resolution, ensuring high availability of supported application systems.

Knowledge Management: Document common resolutions/solutions and application support processes in the IT Service Management knowledgebase to improve efficiency.

Required Qualifications

To be successful in this role, you should have the following qualifications:

Education: Bachelor's degree or equivalent qualification, preferably in Information Technology, Biological Science, or a related field.

Experience: Minimum of 5 years of experience working with regulatory information systems.

Knowledge: Practical understanding and application of cGMPs, particularly in relation to regulatory processes and procedures.

Skills: Excellent customer service, problem-solving, troubleshooting, and verbal/written communication skills. Proficiency in SDLC principles and industry best practices.

Preferred Qualifications

The following qualifications are preferred but not required:

Certification: IT-related certification or equivalent experience. Project management experience is a plus.

Expertise: Content management, Data Migration, PL/Transact SQL, XML, object-oriented design, Trial Master File, Computer System Validation (CSV), and GAMP5 experience is highly desirable.

Regulatory Solutions: Experience with Regulatory solutions such as Lorenz docuBridge, Veeva RIMS, Parexel InSight Manager, GlobalSubmit, ACUTA, eCTD review, and/or ISIToolbox.

Travel: Some travel to other sites may be required.

Join a dynamic team focused on regulatory systems. Apply your skills and expertise to ensure compliance and efficiency in the field. We look forward to reviewing your application!