IT Business Analyst, Regulatory Systems - LS Solutions
Boston, MA 02108
About the Job
Title: IT Business Analyst, Regulatory Systems
Duration: 18-24 Months with possible extension
Location: Remote
Pay Rate:$70.00/hr on W2
POSITION DESCRIPTION:
Summary of the Position:
Client's Information Technology seeks a Business Analyst responsible for all aspects of computer systems related to Regulatory. This position serves as a functional resource and subject matter expert for regulatory systems. The position reports to the Associate Director of Business Technology for Regulatory systems.
Responsibilities include but are not limited to:
· Serves as functional resource and subject matter specialist for Regulatory Information Management (RIM) Systems.
· Determines methods and procedures on new assignments, utilizing business process modeling, data modeling, and analysis.
· Partners with assigned client(s) to identify and evaluate systems and procedures for business solutions.
· Builds strong partnerships with clients and vendors.
· Participates in projects with varying levels of complexity; identifies, manages, and communicating risks associated with projects; may function as a project manager or team lead for projects.
· Collects, documents, and manages user, functional, and technical requirements for regulatory information management systems for the vaccines biologics business space.
· Supports development of business cases; evaluates and qualifies opportunities for business process and technology improvements; and provides insight for development of multi-year strategic roadmaps.
· Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures.
· Participates in system validation, release, and post-deployment support activities with Quality, Validation, System Owners, IT Operations, and IT Service Desk.
· Provides application support for validated applications.
· Interacts with end users on a regular basis to understand their needs and provide guidance and training on technical solutions.
· Troubleshoots technical issues and manage problems through to resolution.
· Develops processes to ensure high availability of supported application systems.
· Documents common resolutions/solutions and application support processes in the IT Service Management knowledgebase.
· Travel to other sites may be required.
Minimum Requirements:
· Bachelor or equivalent qualification level, preferably in Information Technology, Biological Science, or equivalent combination of education and experience is required.
· 5+ years of experience working with regulatory information systems
· Practical knowledge and application of cGMPs (industry experience/awareness) especially relating to regulatory processes and procedures
· Must possess excellent customer service, problem solving, troubleshooting, and verbal/written communication skills
· Practical knowledge of SDLC principles, industry best practices, and assigned system(s) (SDLC/ADLC)
Preferred Qualifications:
· IT-related certification or equivalent experience, project management experience preferred
· Content management, Data Migration, PL/Transact SQL, XML, object-oriented design, Trial Master File, Computer System Validation (CSV), and GAMP5 experience a plus
· Experience with any of the following Regulatory solutions highly desirable: Lorenz docuBridge, Veeva RIMS, Parexel InSight Manager, GlobalSubmit, ACUTA, eCTD review, and/or ISIToolbox.
Employment Type: Contractor
Salary: $ 65.00 70.00 Per Hour
Duration: 18-24 Months with possible extension
Location: Remote
Pay Rate:$70.00/hr on W2
POSITION DESCRIPTION:
Summary of the Position:
Client's Information Technology seeks a Business Analyst responsible for all aspects of computer systems related to Regulatory. This position serves as a functional resource and subject matter expert for regulatory systems. The position reports to the Associate Director of Business Technology for Regulatory systems.
Responsibilities include but are not limited to:
· Serves as functional resource and subject matter specialist for Regulatory Information Management (RIM) Systems.
· Determines methods and procedures on new assignments, utilizing business process modeling, data modeling, and analysis.
· Partners with assigned client(s) to identify and evaluate systems and procedures for business solutions.
· Builds strong partnerships with clients and vendors.
· Participates in projects with varying levels of complexity; identifies, manages, and communicating risks associated with projects; may function as a project manager or team lead for projects.
· Collects, documents, and manages user, functional, and technical requirements for regulatory information management systems for the vaccines biologics business space.
· Supports development of business cases; evaluates and qualifies opportunities for business process and technology improvements; and provides insight for development of multi-year strategic roadmaps.
· Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures.
· Participates in system validation, release, and post-deployment support activities with Quality, Validation, System Owners, IT Operations, and IT Service Desk.
· Provides application support for validated applications.
· Interacts with end users on a regular basis to understand their needs and provide guidance and training on technical solutions.
· Troubleshoots technical issues and manage problems through to resolution.
· Develops processes to ensure high availability of supported application systems.
· Documents common resolutions/solutions and application support processes in the IT Service Management knowledgebase.
· Travel to other sites may be required.
Minimum Requirements:
· Bachelor or equivalent qualification level, preferably in Information Technology, Biological Science, or equivalent combination of education and experience is required.
· 5+ years of experience working with regulatory information systems
· Practical knowledge and application of cGMPs (industry experience/awareness) especially relating to regulatory processes and procedures
· Must possess excellent customer service, problem solving, troubleshooting, and verbal/written communication skills
· Practical knowledge of SDLC principles, industry best practices, and assigned system(s) (SDLC/ADLC)
Preferred Qualifications:
· IT-related certification or equivalent experience, project management experience preferred
· Content management, Data Migration, PL/Transact SQL, XML, object-oriented design, Trial Master File, Computer System Validation (CSV), and GAMP5 experience a plus
· Experience with any of the following Regulatory solutions highly desirable: Lorenz docuBridge, Veeva RIMS, Parexel InSight Manager, GlobalSubmit, ACUTA, eCTD review, and/or ISIToolbox.
Employment Type: Contractor
Salary: $ 65.00 70.00 Per Hour
Source : LS Solutions