Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary . Provides global support related to information and records management systems and ancillary support systems. Essential Duties and Responsibilities can include, but are not limited to, the following . Implement and maintain document repositories and archives . Coordinate review and revision of controlled documents . Perform intake review of documents for completeness and accuracy while maintaining document workflow . Issue controlled documentation to departmental groups upon request i.e. Master manufacturing records, performance copies, logbooks, etc . Maintain an accurate and comprehensive inventory of documentation issued by document control i.e. Master manufacturing records, performance copies, logbooks, etc . Provide end user guidance in use of Electronic Document Management System EDMS . Coordinate document requests and stage documents for presentation during regulatory inspections . Identify areas for continuous improvement for processes based on experience and customer feedback . Participate in site-wide project teams as necessary . Maintain departmental databases . Prepare metrics/reports for management. Knowledge, Skills, and Abilities . Knowledge of document databases and other electronic document management tools e.g. eDocCompliance, FileMaker Pro . Attention to detail and organizational skills . Ability to work independently with moderate supervision . Ability to work in a team environment . Ability to work well under time restraints . Experience with Microsoft Office - Word, PowerPoint, Excel, Access, and Outlook . Education and Experience . Associates degree with 0-2 years relevant experience or . Equivalent combination of education and experience Level will be determined by education and experience. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
