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

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.
• 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.

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.

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.

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.

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.