Consultant, Regulatory Strategies

Thomson Reuters is a global leader in providing essential information to the world's businesses and professionals in Law, Financial Services, Tax & Accounting, Media, Healthcare and Scientific Research. With our deep expertise and understanding of theses professions, we are able to offer our customers a broad range of innovative products and services.  The relevant, insightful information and intuitive supporting systems we provide enable our customers to be successful.  Thomson Reuters has operations in 93 countries around the globe.  More information about Thomson Reuters and its financial performance can be found on www.ThomsonReuters.com.The Scientific business of Thomson Reuters provides information and knowledge to accelerate research, discovery and innovation. Our authoritative, accurate and timely information is essential for drug companies to discover new drugs and get them to market faster; researchers to find relevant papers and know what’s newly published in their subject; and businesses to optimize their intellectual property and find competitive intelligence.  We will create the research platforms and services of the future that will power our customers toward business and personal success.This position’s overall responsibility is to assist the Regulatory Strategies team with identification and review of regulatory issues likely to impact Scientific’s solution suite, including registration tracking, submission management, document management, and submission publishing software and services offerings.This position will perform three key functions at Scientific:  input into product strategy, regulatory advisor, and business process consultant for Scientific. Key product strategy input activities include the following: Providing input into changing regulatory requirements may impact key life sciences clients and other industry members. Provide input into Scientific product requirements for addressing changing requirements. Communication and training of Thomson Reuters employees on key regulatory initiatives for product strategy.Key regulatory advisor activities include the following: Perform reviews and summarize relevant guidance. Process Consulting activities include the following: Work on strategic consulting opportunities or as subject matter expert in client billable projects. Work with Sales in support role as needed, including guiding customer towards strengths of Scientific suite of products. Assisting with implementation workshops. Role may be further defined to a specific region, such as the United States, Europe, Japan, or other identified region. Minimum BS/BA. Minimum of 4 years in working with Life Sciences organizations in defining requirements for and/or implementation of regulatory solutions. Understanding of regulatory processes from early development through product retirement. Experience in filing various types of submissions (IND, CTD, NDA, NDS, MAA, Annual Reports, labeling changes, etc.) producing both paper and electronic output for delivery to regulatory agencies. Knowledge and understanding of regional Regulations and Guidance and ICH guidelines. Familiarity with CTD and eCTD specifications and lifecycle concepts. Understanding of electronic labeling requirements including SPL or PIM. Experience with document management and publishing solutions in use by Life Sciences clients, such as Documentum and CoreDossier and/or EZsubs. Demonstrable presentation preparation and delivery skills/experience.  Knowledge of software development and deployment process. Understanding of system validation requirements. Domestic and international travel.  May include up to 50% travel. The H-1B visa cap has been fulfilled for fiscal year 2008 which begins October 1, 2007 and therefore Thomson Reuters is unable to sponsor new (first-time) H-1B visas. Thomson Reuters employees take pride in providing our customers around the world with information that is timely, accurate, unbiased and trusted. We have a profound respect for the professions and customers we serve and define our success in terms of their success. Our work environment is dynamic, innovative and entrepreneurial. We have a result- oriented culture that demands excellence, agility and the desire to move quickly and precisely to seize opportunities. Our environment is both challenging and supportive — we give employees the opportunity to develop their skills and do their best work. Thomson Reuters values diversity of culture and thought, and seeks talented, qualified employees in all its operations around the world regardless of race, gender, national origin, religion, sexual orientation, disability, age or any other protected classification under country or local law.  Thomson Reuters is proud to be an Equal Employment Opportunity/Affirmative Action Employer. Company: Thomson Reuters Location: Horsham, PA 19044 Job Status Full Time, Employee Job Category: Biotech/R&D/Science Career Level: Experienced (Non-Manager)