Liam Curran Email & Phone Number

Palo Alto, California, United States

Responsible for strategic, operational, and business support for Ascendis Pharma’s Regulatory Information Management (RIM) platform, in close partnership with the IT and Regulatory groups• Serve as RIM Subject Matter Expert for Regulatory technology strategy• Provide Regulatory system and data related business support, implementation, and change management• Engage with business process owners, stakeholders, vendors, IT colleagues, and others as necessary to define system issues, resolutions and opportunities• Maintain a current understanding of industry expectations for system management and ensure that they are reflected in any technical strategy and business changes accordingly• Support data integration, data quality and the development of data governance standards to facilitate reporting and business decision making• Partner with industry organisations and health authorities to influence outcomes relating to emerging requirements such as ISO IDMP• Coordinate cross-functional technology awareness and education sessions• Provide strategic updates and guidance to the Regulatory Affairs Senior Leadership Team as well as petitioning for endorsement of new initiatives• Serve as a key member of the Regulatory Operations team, helping to identify, propose, develop and manage improvement projects

El Granada, California, United States

El G Consulting focused on Life Sciences data, systems, strategy, and technology management. Delivering broad experience in pharmaceutical and biotech companies while working across functional disciplines, geographies, and technologies. Focused on research and development operations, solutions, and strategies:• Data and information management including strategy development, technology selection, implementation, validation, and integration• Operational experience across regulatory, clinical, and pharmacovigilance business functions with proven capabilities in delivering product approvals• Expertise in common data challenges such as MDM, Data Integration, Data Quality, RIM, and IDMP.

Foster City, Ca

Head of the DevOps Innovative Solutions and Collaboration Team within the DevOps Systems and Process Department. Focused primarily on Regulatory Affairs (RIM) and Pharmacovigilance (PV) applications and initiatives, as well as Dev Ops-wide strategy, alignment, and collaboration.Led a team of over 70 FTE and contract personnel covering: International Systems Training and Support – Application support and training for all global sites;Platform Development and Maintenance – Implementation and management of global use platforms; Systems Project Management Office – Digital Strategy Portfolio Management and System Projects PMO;Knowledge Management and Development – US, Intl, and Offshore application development and information collaboration management (i.e., SharePoint site collections, visualizations, data standards).

Foster City, Ca

The Regulatory Information Systems department was dedicated to providing high-quality systems, training, and user support to enable Development Operations to meet obligations for regulatory submissions at all Gilead sites. This includes review, selection, implementation, and maintenance of all platforms, connectivity, and software tools necessary for daily operations and Regulatory Submissions, globally.Developed function to 26 individuals working across nearly 30 technologies in the US and the UK in support of global Regulatory Affairs business processes. Analyzed trends and evaluated potential impact of changes in government regulatory activities in order to provide expert analysis and advanced planning to meet obligations around emerging regulations and technologies. Led long-term initiatives focused on building global efficiencies in the department. These included custom SharePoint applications in support of global document inventories for major submissions and global coordinated responses, as well as label, license, safety compliance, and commitment tracking. Served as key participant and lead in long-term strategic technology planning for Development Operations and Regulatory Affairs.

Foster City, Ca

Head of Regulatory Information Systems (RIS): Formed a new function for all platform and application implementation, validation, maintenance, training, and support for the global Regulatory Affairs Department.Centralized and implemented all business technical tools management under a single function. Managed team responsibilities to assess and implement technology solutions for unmet or inefficient business needs including commercial off-the-shelf (COTS) software, as well as custom developed applications. Analyzed trends to provide expert analysis around emerging regulations and technologies. Provided GxP risk assessment, CAPA, change management, and CSV oversight.

Boulder, Co

Head of Global Regulatory Operations (5 sites): 2007-2009Boulder, CO; Cambridge, UK; Durham, NC; Foster City, CA; Seattle, WALead submission of Gilead's first eNDA and eCTD.

Westminster, Co

Head of Regulatory Operations. Formed new function at company responsible for Regulatory Submissions and information management. Submitted company's first eCTD in May 2005. Acquired by Gilead.

Mountain View, Ca

Led Regulatory Submissions Team at ALZA (a Johnson and Johnson company). Implemented new software solutions to speed submission processes including Documentum EDMS, eNDA Submissions, and a Submission Tracking Database.

Sunnyvale, Ca

Implemented and supported electronic submission software platforms: CoreDossier and Documentum. Supervised change management, support, and upgrades of various submission software tools and platforms. Responsible for daily submission preparation in paper IND format and electronic submissions in eNDA format.Sr. Associate: April 2000-February 2001Manager: February 2001-February 2003Sr. Manager: February 2003-June 2003

Berkeley, Ca

Quality Assurance Associate responsible for oversight and review of Manufacturing Batch Records. Documentation specialist and archive maintenance specialist using Interleaf's Regulatory Document Management (RDM) system

Berkeley, Ca

Laboratory Associate in an HIV diagnostic facility.