James Cronin Email & Phone Number

United States

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Stamford, Ct, Us

Direct projects, staff, budgets, and global initiatives within IT in support of all of Purdue’s R&D departments, including Discovery, Pharmaceutics, Pre-Clinical Development, Program Management, Regulatory Affairs, Medical, Risk Management, Drug Safety, Corporate Security, and Licensing and Business Development.• Coordinate and assemble department capital (>$2.25M) and expense budgets (>$2M) to align with company goals working with R&D departments and IT. Oversee a staff of 8 across 2 geographical sites to support business operations. • Streamlining Data Analytics environments to run faster, use cheaper storage solutions, while providing delivery of services through desktop and mobile environments. Architecture of environment mixes hosted solutions with on-premises capabilities via SAS, Oracle, R, and Cisco platforms. • Architected on-premises system integrations with externally hosted Clinical Development applications and services to manage and monitor trial execution.• Reduced capital spend for Drug Safety application upgrades by >80% through strategic planning of system refreshes and re-use of project deliverables and staff skills.• Planning security requirements for new manufacturing plant in North Carolina.• Develop and communicate technical strategies to the R&D departments and IT, including: a) multiple system R&D search that made information across varied systems available from a common interface to R&D personnel, b) 18-month core system upgrade plans that take advantage of existing support & maintenance contracts while avoiding high cost capital projects and retaining system knowledge internally, c) consolidation of Regulatory electronic documentation to ensure one system with official submission records exists, and d) centralization of R&D decision-making information.

Cambridge, Ma, Us

Administered the training program for the use of the Enterprise Document Management System (EDMS)Directed design of EDMS Cabinet/Folder structureMaintained functionality and validity of CoreDossier database Compiled and published complex FDA submissions using CoreDossier publishing softwareEdited and provided quality control of drug reportsProvided input for the development of standards and optimal business processes related to EDMSWrote cover letters and summaries for submissions to FDA

New York, Ny, Us

• Wrote and published news briefs and obituaries that appeared in the New York Times• Edited Digest column on page one of the Business Day section