Job Description

Collaborates with data owners to ensure that data is entered into the company's RIM system(s) in compliance with company / industry / agency standard(s). Prepares and ensures the submission of data and supporting documentation to external agency databases (i.e. XEVMPD, ISO IDMP) in compliance with agency requirements and standards. Builds strong working relationships with information providers / verifiers (primarily) within Regulatory Affairs to encourage and support accurate, timely and reliable entry of Regulatory information into the company's RIM system(s). Supports the Regulatory Affairs team in the analysis of Regulatory Information to identify trends that can be presented in business intelligence reports to management. Coordinate with Regulatory Affairs/Operations colleagues in the receipt and archival of regulatory files transmitted from global partners and affiliates. Provide end user support and additional guidance/training for the company's eDMS, resolving IT tickets to support end users and creating accounts for any new users. Perform administrative functions as directed by Management to support projects and to ensure the smooth operation of the department. Assist in publishing efforts during peak workloads or as required. Bachelor's degree or relevant equivalent experience. Experience with Regulatory Information Management is required Knowledge of XEVMPD and IDMP requirements. Knowledge of CTD format and submission requirements in applicable region(s). Exposure to drug development, including knowledge of the contents of regulatory submissions and product life-cycle and how other functions contribute to them. Advanced experience in MS Word, MS Excel, SharePoint and Adobe Acrobat. Experience with electronic document management software, eCTD publishing software, principles of information systems, and related technology is required. Confidence and ability to learn new software tools is essential. Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills

Skills Required