Title Regulatory Information Associate  About the Organization My company shares my passion for helping to improve human health around the world." "This is My MedImmune." Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.   Description Title: Regulatory Information Associate Location: MD, Gaithersburg - Corporate Headquarters Req: 02090 Position Summary: The Regulatory Information Associate oversees the daily operation and maintenance of the electronic regulatory repository or EDMS, and ensures that official paper regulatory files are maintained, according to regional agency requirements. Ensure the appropriate indexing of all documents, including relationships and document lifecycle management, to insure that subsequent searches are successful. Major Duties and Responsibilities: • Manages regulatory files by overseeing the indexing and maintenance of electronic and paper documents • Provides regulatory searching expertise in support of Regulatory Affairs by performing complex search and retrieval functions on the official regulatory repository or EDMS • Provides submission history information on all MedImmune products • Represents regulatory information area, when needed, in any submission related working groups that may need their expertise to support submission activities • Supports the regulatory staff in submitting documentation to regulatory agencies, including the preparing, copying and shipping activities required • Supports Regulatory Affairs by indexing documents and filing within the Document Control Room (DCR) • QCs archival documents for inclusion in regulatory submissions as needed • Adheres to official retention and archiving schedules for the DCR • Maintains document archival workflow, as it pertains to archiving and filing in DCR • Supports Regulatory Affairs on all Due Diligence activities as required • Supports the Legal department with discoveries, as they pertain to Regulatory issues • Responsible for quality control of all documents, both paper and electronic, prior to entering the Regulatory Archives, to ensure accuracy and consistency • Responsible for the daily production and submission to Agencies of all maintenance dossiers e.g. Protocols, Amendments, Safety Reports, Annual Reports, etc.   Position Requirements Job Complexity: Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors Supervision: Manages and coordinates the archival/retention/storage of paper and electronic records for the department   Educational Requirements Education: • Undergraduate degree in Information Science, Business, English, Communications or related field, or relevant experience Experience: • Two years of Pharmaceutical experience • Knowledge of document management technology and electronic publishing preferred • Skilled in using desktop applications • Skilled in indexing Regulatory documents • Experience in organizing discovery processes • Good knowledge of indexing methods • Good understanding of regional Agency regulations and submission process • Ability to work under pressure and adhere to deadlines • Skilled in managing multi-project tasks • Must demonstrate the following job competencies: results orientation; thoroughness, critical information seeking, concern for impact, concern for standards   Company Info None Specified  This position is currently not accepting applications. To search for an open position, please go to http://medimmune.appone.com/

 

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