Information Management Manage at Cambridge

Job Description

A major biotechnology company is seeking an Information Management Manager located in Cambridge, MAThe Information Management Manager is responsible for collecting and reporting key information to the Regulatory Leadership group around project status, regulatory filing status and other key metrics.The Manager will maintain the project listing of all active and planned projects. These projects include IT, process improvement and other projects. The resource will collect status reports including issues, challenges, decisions needed and additional resource need from the project managers for the respective projects and consolidating these into a monthly status report.The resource will also collect and reporting key milestone information around our key programs. This information includes status of key clinical trials and / or status of the filing documents. These filings include but not limited to BLAs, NDAs, MAAs, Annual Reports, Variations, and other key documents. The resource will work with key resources and systems to collect this information and develop executive level dashboards and reports that summarize this information.The Manager will also be responsible for developing key operational, financial and performance metrics and then collecting and reporting on these metrics. The metrics will be related to key regulatory performance goals to ensure progress is being made against these goals.The individual will not necessarily have strategic or operational responsibilities, but will focus on collecting, summarizing and reporting this information for consumption by the regulatory leadership teams.Responsibilities:Collect and report status of key projects.Collect and report status of program milestones.Facilitates the definition of the regulatory metrics aligned to the mission and goals within regulatory.Develop necessary process and identifies key IT systems that will facilitate the collection of the data needed to develop the information needed.Develop executive level reports that summarize the information collected into manageable and actionable information.Report the information on a periodic basis (monthly and / or Ad Hoc) to the regulatory leadership team.Maintains summary project milestones and plans, issue logs, and other project related artifacts.Minimum Educational Requirements:Bachelors Degree. PMP certification. Life Science background.Regulatory background preferred. Master Degree preferred.Skills / Knowledge Required:5+ years of experience as a Project ManagerPharmaceutical, Bio-Technology, or Life Science industry experienceExperience with Regulatory Processes and Systems a plusStrong Customer and Business Relationship Management skills

Job Requirements

 
Country: USA, State: Massachusetts, City: Cambridge, Company: InVentiv Health.