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Seasoned regulatory & quality expert Mark Willoughby will help guide both platform and application development, building on client feedback.
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He will also spearhead new growth as the CARA™ Life Science platform gains traction right across Quality, Regulatory, Safety & Clinical operations, providing seamless out-of-the-box integration & cross-functional data and content management.
London, UK – Generis, the creator of CARA™, the data and content management platform that helps life sciences companies transform their complex business processes, has created a new Head of Life Sciences role and appointed Mark Willoughby, a deeply experienced Regulatory and Quality expert. He will direct both onward platform and application development and drive new growth for Generis’s CARA™ Life Science platform.
Mark brings to the role a long and impressive track record in Regulatory and Quality, most recently as Head of Systems and Data Management in the Quality function at ADVANZ PHARMA, where he worked for five years, with a remit spanning submissions management, XEVMPD and systems strategy. During that time he oversaw a move to the cloud, systems consolidation and integration, and initiation of their master data management strategy.
Of his move to Generis, Mark said, “Generis has been on my radar for some time: they’re a very exciting company doing some really interesting things. Their understanding of the role between data and documents, and of the potential for structured content management and authoring, is way ahead of other software companies. These developments will have a significant impact on Regulatory Affairs and how companies manage their information and activities - especially as IDMP becomes established in Europe, and as DADI [digital application dataset integration] takes over from electronic application forms in Europe as a first major step in IDMP implementation.
“What’s different about Generis’s CARA Life Science Platform is that it’s truly integrated and supports Quality, Regulatory, Safety and Clinical data and document use cases from the same single platform,” he continued. “Other companies may offer different systems on a common platform, but typically they can’t talk to each other which creates new barriers for companies. CARA can transform everything from change control, regulatory submissions, safety label updates and clinical trial management – by allowing everything to be coordinated across a single platform out of the box.”
Before joining ADVANZ PHARMA, Mark spent four years at Indivior, as Manager for Regulatory Operations. He previously ran his own consulting company, which was responsible for setting up Boots’ eCTD publishing system. Before that, he worked for ISI (formerly CSC), on the client side, supporting regulatory submissions, product feedback and staff training, and spent three years in Regulatory Operations at Pfizer’s Global Research and Development centre in Sandwich.
Commenting on Mark’s appointment, James Kelleher, CEO and founder of Generis, said, “We’re delighted to welcome Mark as Head of Life Sciences. His extensive experience gained from working within Regulatory Operations will help define the ongoing enhancements to our CARA Life Science Platform, while deepening the subject-matter expertise we bring to customer implementations.”
In addition to fast-growing sales of the CARA Life Science Platform, Generis has seen soaring cases of companies extending their use of the platform across their operations. In December, ambitious German biotech Affimed confirmed that it had selected CARA to support R&D teams across its entire product development lifecycle – beginning with CTMS, eTMF and DMS capabilities, to be followed by RIM, Labelling, QMS, SOP and learning management use cases in due course.
Generis’s Life Sciences business has grown rapidly over the last year, in Europe, the US, Japan and beyond, fuelled by a series of strategic company appointments and new partnerships.
Press Contact for Generis
Carina Birt, Sarum PR
+44 7970 006624
carina@sarumpr.com
