02 Mar
Regulatory Information Management (RIM) Associate
Massachusetts, Cambridge , 02138 Cambridge USA

Title: Regulatory Information Management (RIM) Associate

Location: Remote , Cambridge, MA

Contract: 9+ Months


Job Scope:

What is this job's focus?The Regulatory Information Management (RIM) Associate will work within a team environment under the direction of the RIM Data Lead in evolving the RIM data and reporting landscape.Key Responsibilities:List key responsibilities of the job; include any Supervisory responsibilities (if applicable).Activities may include; the execution of centralized administrative functions related to RIM analytics, translation of customer needs to technical reporting requirements, oversight of report/dashboard design and build to ensure customer value, troubleshooting of system report issues and collaboration with IT to deliver enhancements.Facilitate availability of appropriate RIM data to various BI tools. Execution of business system administrative functions (system access, controlled vocabularies, TEP maintenance, etc.) across RIM capabilities.Essential Skills and Qualifications Required:Requires understanding the regulatory customer perspective, ability to translate to the data and the data model in the RIM Ecosystem.The role is expected to take direction from various levels of management, be collaborative in working style, have focused attention to detail and ask questions as needed.Understanding of RIM data and regulatory process would be advantageous.Education and Experience Requirements for Job:Education Bachelor's Degree (Information Systems of life sciences preferable or equivalent industry experience Experience 3-5+ years of experience of experience in Pharmaceutical, Bio-Technology, or Life Sciences, with a specific focus in Regulatory and working knowledge of Biopharma drug development and approval process 3-5+ years' experience in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a similar capability model in GxP/Regulated Systems.

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