Shire Pharmaceuticals’ Senior Manager for Global Regulatory Operations Joins ISI’s Regulatory Consulting Practice
London, UK – June 23rd , 2008 – Image Solutions, Inc. (ISI), a leading provider of software and services for the life sciences industry, today announced the appointment of Kate Wilber, formerly Senior Manager for Global Regulatory Operations at Shire Pharmaceuticals, to a senior role within its Regulatory Consulting practice, further bolstering ISI’s growing European business.
A US national based in England, Kate joins ISI (UK) Limited, the wholly-owned subsidiary of ISI Inc, where her role will be to provide business process expertise and advice to ISI’s clients on an international basis. She will report to Toban Zolman, ISI’s Director of Consulting Services.
At Shire Pharmaceuticals, Kate headed up a cross-functional eCTD implementation team, a role which involved collaborating with external consultants to define global eCTD metadata standards; addressing training needs throughout regulatory affairs as well as across R&D; and managing multiple major submission publishing teams for both US and EU applications. The role also included the implementation of ISI’s eCTDXPress, ISIPublisher and ISIRegTracker business applications.
In her new position as Senior Regulatory Consultant at ISI, which she will assume on July 7th, Kate will operate within the UK business’s professional services organisation, where she will be responsible for delivering advisory, best practices, analysis and execution-related support within regulatory operations consulting projects. She will also be responsible for operational activities, project management of on-site client projects including submission management, RA and line-function relations.
Commenting on the appointment, Adam Sherlock, ISI’s UK Managing Director, said: “This is fantastic news for ISI and our customers. Kate brings a wealth of knowledge and experience of the regulatory publishing and submission business process, in all output formats, and to all major agencies on a global basis. Her know-how will be invaluable in assisting ISI’s clients to optimise their regulatory business operations and maximise the benefit they can derive from implementing ISI software and services. We welcome her on board.”
Prior to joining Shire, Kate worked at Liquent for three years, most recently as a Product Manager for the publishing solutions business. She graduated with a Bachelor of Science degree in Mathematics from Dickinson College in Carlisle, Pennsylvania.
About Image Solutions
Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and since has delivered more than 1,500 electronic submissions and 900+ eCTD submissions. The company has a 48 percent market share among Top 50 global pharmaceutical for its flagship submission product, eCTDXPress.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations. For more information, visit the company website at www.imagesolutions.com.
PR for ISI Europe
+44 1722 411150
This press release was distributed by ResponseSource Press Release Wire on behalf of Sarum PR in the following categories: Medical & Pharmaceutical, Computing & Telecoms, for more information visit https://pressreleasewire.responsesource.com/about.