Regulatory Affairs Systems Manager

Position Summary:Reporting to the Associate Director for Regulatory Operations Systems, this position will support MedImmune’s ongoing regulatory initiatives by assisting in the planning and implementation of departmental information systems required for Regulatory Operations. The role provides system analysis, business analysis, and technical support for the implementation, validation, and life cycle management of Regulatory systems/databases. The position also includes involvement in the full system development lifecycle and requires knowledge of the project implementation and management process. This will involve participation in workshops, interviewing key staff, authoring and reviewing related requirement documents, and providing support in the selection, implementation, and validation of Regulatory systems/databases. Major Duties and Responsibilities (including supervising others):1. Assists in the analysis and implementation of Regulatory systems/databases by: a. Defining and authoring user requirement specifications b. Participating in the selection of Regulatory systems/databases c. Assisting in the design, build (as needed), testing, validation, and documentation processes d. Performing project management activities (as needed) 2. Tracks status of all ongoing Regulatory system projects 3. Recommends system improvements and coordinates implementation 4. Assists in providing system automation needs and support for Regulatory 5. Supports system-related initiatives in support of Regulatory submissions 6. Acts as liaison between Regulatory and IT by: a. Ensuring departmental strategy integrates with enterprise-wide IT technology strategy b. Informing the IT department of Regulatory’s IT needs 7. Ensures validation requirements are in compliance with FDA 21CFR Part 11 and related regulations 8. Creates an effective, collaborative relationship with IT 9. Initiates new solutions to aid in the automation of Regulatory processes by being aware of advancements in scientific computing technologies and current Regulatory guidelinesRequirements/Qualifications:Education: BS/BS degree in a scientific discipline or Information Technology required. MS in Computer science, chemical, or biological science preferred.Experience: Five years of industry experience within a pharmaceutical or biotech environment with a minimum of three years experience in systems analysis and development of Regulatory systems.Special Skills/Abilities: Experience should include: 1. Implementation and validation of Regulatory systems such as submission publishing software 2. Business requirements gathering skills 3. Project management and business process improvement skills 4. Working knowledge of pharmaceutical submissions 5. Experience supporting business users in a Regulatory environment 6. Broad knowledge of current technologies used within an IT infrastructure (network, Citrix, performance), computer systems (Windows), database (MS SQL, Oracle) and software development architecture (MS.NET Framework), and the ability to apply technical knowledge to support the business need 7. Ability to develop and deliver effective presentations 8. Excellent written and verbal communication skills 9. Highly organized with a strong attention to detail 10. Ability to handle multiple tasks simultaneously and effectively with limited oversightJob Complexity: 1. Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors 2. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutionsSupervision: Has the ability to work independently with minimal supervision.  MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Regulatory Affairs Systems Manager Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Biotech/R&D/Science Company: MedImmune Inc.