Position will design, develop and implement the electronic registration dossier processes within the local facility, as well as to and from other sites in North America involved in regulatory documentation. This position will liaison with all external CROs and organizations involved in providing documentation to facilitate receiving electronic documentation that meets local and international requirements. Additionally, will monitor electronic tool evolution, determine appropriate updates, monitor regulatory agency requirements and trends and cooperate fully with international operations to insure commonality of IT tools in conjunction with corporate standards, in order to make regulatory submissions to FDA, or other world wide Regulatory Agencies. Experience with Documentation and Core Dossier is required.
Experience developing and managing projects in a regulated environment is beneficial.
The ideal candidate will possess excellent interpersonal, organizational and time management skills, and have proven experience in training. The ability to manage in a fast-paced environment with the flexibility and adaptability to adjust to frequently changing priorities is a must. Send e-resume with narrative cover letter elaborating on your qualifications and interest in this job, current salary data, and daytime phone. Copyright 1997 Alpha Systems,Inc. All rights reserved.