Document Specialist I

Position Summary: The primary role of the position is to maintaining project documentation files and provides strategic planning, and oversight to allow the department to consistently achieve their mission, provide quality support to project teams and achieve departmental and corporate goals and objectives on time and on budget. Major Duties and Responsibilities:  Performs filing, scanning, sorting and quality control of case report forms and study related documents.  Assist in logging, processing and entry of all documents arriving in the document room into the database designed for tracking and report generation.  Create and maintain index of study documents in preparing for document archiving in-house and archiving closed study files for off-site storage.  Proactively manage the Trial Master File (TMF) to support clinical trials and regulatory submissions.  Reviews data discrepancies and consult with functional leader groups for resolution.  Other duties as assignedRequirements/Qualifications:  1+ year of clinical trial experience with a minimum of 1 year directly involved in TMF / regulatory document review and management.  Must have the ability to cope and adapt to rapidly changing situations and timelines, be comfortable changing direction and leading the team through periods of ambiguity.  Must be able to constructively work through conflicts within the group as well as cross-functionally and be able to persuasively influence outcomes.  Must have a strong work ethic and be self-motivated to maintain expertise in all areas related to TMF as well as personnel management in order to ensure the efficient and compliant operation of TMF at all times.  Must be enthusiastic about work with an ability to manage multiple projects concurrently while maintaining a positive attitude and work environment.Education: 1+ year of relevant experience 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: Document Specialist I Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Administrative/Clerical Company: MedImmune Inc.