Senior Regulatory Consultant

SummaryThe Senior Regulatory Consultant at Liquent, a Thomson Company, assists in the production of regulatory submissions in accordance with defined agency guidelines, oversees assigned resources, and ensures the timely creation of electronic and paper submissions for Liquent customers. This position is part of the Liquent Direct team working in all aspects of regulatory affairs and publishing consulting.DescriptionDuties include visiting client sites, performing and developing product demonstrations, understanding customer requirements, leading workshops and regulatory discussions. Additional duties include developing and maintaining regulatory client relationships and customer advocacy, representing Liquent at conferences and exhibitions, and maintaining a sound understanding of current and future regulations.

Job Description
-Conduct on-site regulatory software and process workshops
-Provide project team leadership for publishing projects
-Provide publishing support and guidance for customers
-Capture client ?wish list? for feedback to product managers
-Responsible for coordinating all aspects of regulatory submissions
-Provide problem-solving and process improvement expertise
-Propose and develop innovative solutions and assess impact of production
-Maintain current awareness of relevant FDA regulations and guidelines, technology trends as well as industry standards concerning best practices, document/information management and FDA submission requirements
-Apply technology to produce electronic and paper submissions by working with customers to lead, train, and provide issues resolution on the use of templates, authoring environment and publishing processes
-Work with customer in the coordination, organization and management of assigned to the submission projects to meet defined publishing deadlines
-Partner with internal teams in designing and implementing the documentation and submission templates
Qualifications-BA/BS college degree in life sciences or a technology related discipline
- 2-3 years of experience with CoreDossier, EZsubs and other Liquent products
-End to end regulatory submission publishing experience
-Knowledge of regulatory submission content and formats
-Ability to articulate procedures and solutions to multilevel team
-Strong interpersonal skills to conduct successful client interactions
-Proficiency working in Microsoft Windows environments and Windows based applications including, but not limited to Microsoft Office products, Adobe Acrobat, desktop publishing and graphics packages
-The ability to work independently and as part of the team
-Ability to learn new technology and apply to business needs
-Experience with document/content management systems
-An understanding of software validation concepts and the ability to execute against defined plans
-Strong organizational and interpersonal skills with a customer service focus