Manager RA / 08-5108

Sanofi Pasteur in the USA is a leader in the research, development, manufacture, marketing and sales of vaccines and immunological products because here we clearly see a better tomorrow for all mankind.We have a wide range of vaccines that protect against 20 diseases, but we believe there is still much work to be done. On every continent there exists viruses and bacteria, and we won’t rest until they are eradicated and all people can live healthy, full lives. We’re confident we can achieve our goals. As a subsidiary of Sanofi Aventis, the global pharmaceutical corporation, we have access to the resources needed to continue our boundary-breaking innovations far into the future.Our US site is located in Swiftwater, Pennsylvania, among the scenic Pocono Mountains, sanofi pasteur is housed in state-of-the-art facilities on a 269-acre campus. It is here that our multidisciplinary teams of 1900+ professionals work together to develop and provide new and improved immunological products. Our company is comprised of three global functions: Research & Development, Industrial Operations, and Commercial Operations, as well as seven support functions: Communications, Corporate Development, Finance and Purchasing, Human Resources, Information Solutions, Legal and Corporate Affairs, and Public Policy.For those who wish to make a difference in the world by aiding in the development, production or marketing of vaccines that are critically important to public health, sanofi pasteur offers superb opportunities. Our modern research, production and administrative facility attracts exceptional talent from businesses and universities around the world. Our location offers our people the best of outdoor living close to the cultural, culinary and recreational attractions of Philadelphia and New York City.sanofi pasteur US is a place for those who desire a challenging and rewarding career without compromising their quality of life. If you have the passion, desire, ambition, vision and talent we’re looking for, we invite you to explore our opportunities and to apply online at: www.sanofipasteur.us

Position Description:

The Manager, RA ORIM is responsible for development, implementation, and operation of global RA and cross-functional processes for electronic document management, regulatory publishing, archiving, and data management. The Manager RA ORIM is responsible for priority submission development activities such as section-and file-level publishing, as assigned. Additionally, the Manager RA ORIM is responsible for developing and implementing short- and long-term strategies for future RA information management needs including planning for compliance with emerging external requirements (e.g., eCTD, SPL, PIM, secure information exchange, etc.). The major results are the establishment of functional, efficient cross-functional submission and data processes, and meeting schedules for key submission projects.We are an equal opportunity employer M/F/D/V.

Qualifications:

Minimum BS/MS in Scientific discipline, Information Systems, or Health Information Management with 4-6 years relevant regulatory affairs experience.Working knowledge of IND/CTA, eNDA/eBLA, CTD,eCTD submissions, XML, document management systems, regulatory databases, clinical data standards (H17/CIDSC), electronic labeling standards (PIM, SPL), E2B safety reporting.