IS Business Analyst III, Regulatory

RCM Technologies (USA)
Gaithersburg, MD
Sep 22, 2020
Sep 29, 2020
IT, Systems Analyst
Full Time
Responsibilities include but are not limited to: Serves as functional resource and subject matter specialist for Regulatory Information Management (RIM) Systems Acts independently to determine methods and procedures on new or special assignments Provides advice, guidance, and training to colleagues Makes recommendations on vendor selection and oversees vendor activities Participates in projects with varying levels of complexity Collects, documents, and manages user, functional, and technical requirements for regulatory information management systems for the vaccinesbiologics business space Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures Manages qualification/data migration protocols for supported applications Participates in system release and post-deployment support activities with Quality, 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 Biological Science or equivalent combination of education and experience is required IT-related certification or equivalent experience, project management experience preferred 8+ years of experience working with regulatory information systems Practical knowledge and application of cGMPs (industry experience/awareness) especially relating to quality assurance 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) 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, Parexel InSight Manager, GlobalSubmit, ACUTA, eCTD review, and/or ISIToolbox. Experience with ITIL, COBIT, or other IT good practices desirable Contributes to building high performing teams Motivates self and others RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. RCM Technologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages. #Monster #CB #Dice