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IS Business Analyst III, Regulatory

Company: RCM Technologies
Location: Gaithersburg
Posted on: September 17, 2020

Job Description:

Reference # : 20-00717 Title : IS Business Analyst III, Regulatory Location : Gaithersburg, MD Position Type : Direct Placement Experience Level : Start Date : 08/31/2020 Description 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.

Keywords: RCM Technologies, Washington DC , IS Business Analyst III, Regulatory, Professions , Gaithersburg, DC

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