It is with deep sadness that we announce the passing of our colleague Jamie Hijmans, the President and Chief Technical Officer of our sister company, Global Exponential Technologies (GxT).
Under Jamie's stewardship, GxT was founded and developed into a full stack software development company responsible for the development and launch of several stand-alone products, including: ADDM TrendTM, SmartComplaintsTM, and RegWriterTM. Jamie was a thought leader in the development and implementation of AI applications to support regulatory submissions for the medical device and biopharma industries and will be sorely missed for his unique ability to bridge the gap between the rapid innovations in software automation and industry's regulatory needs.
Jamie is survived by his wife Kyler, daughter Pax, father Marty, and brother Carey. Our thoughts are with his family during this difficult time. We appreciate your understanding and support as we navigate this profound loss.
Industry Changes and Tech Integration Shaped the Week Long Beach, CA. The Global Regulatory Writing and Consulting team returned from RAPS Convergence last week and are excited to share their successes and what they learned at the conference. Jamie Hijmans, Chief Technical Officer of GxT, Bijal Patel, Associate Manager of Medical Device, and Craig Claussen, Senior Director of Regulatory CMC represented the Global team. They spent last week, September 17-19th, in Long Beach having great discussions with industry peers and connecting with partners. This year, the conference focused on tech in the regulatory space and the Global team was able to engage participants with cutting edge demos of our GxT RegWriter™ software. RegWriter™ is a custom application that uses cutting edge AI augmentation for end-to-end eCTD Module 3 and regulatory document authoring. The team left the conference with renewed excitement for the potential of these new technologies have to improve efficiency in the regulatory space.
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The team hosted a successful presentation and has multiple inquiries for demos of RegWriter™. As the industry explores machine learning and AI integration, Global is leading the way, backed by scientists and experienced writers to ensure the adoption of this technology increases accuracy and efficiency.To learn more about RegWriter™ and other tech product offerings, click here: GlobalxT.
Craig Claussen joins GLOBAL with a wealth of experience in CMC regulatory affairs, previously serving at AbbVie and BlueRock Therapeutics. In these roles, he has been instrumental in shaping strategies for complex investigational biologics and cell and gene therapies, and has garnered extensive experience in global submission preparation and lifecycle management. His profound understanding of the evolving regulatory landscape for these advanced therapies, combined with his expertise in navigating the challenges of CMC development in dynamic clinical programs, positions him as an ideal leader for our CMC regulatory function. Craig is known for his emphasis on cross-functional strategic partnerships, collaboration with technical and clinical development experts, submission excellence, and dedication to professional development. His approach aligns seamlessly with our commitment to advancing regulatory practices and ensuring the highest standards of regulatory compliance.
GLOBAL proudly announces the appointment of Sarra de Valence, PhD, as Vice President of Medical Devices and Operations. Having been an integral part of our team since 2020, Sarra served as Associate Director of the Medical Device Team before progressing to her recent position as Vice President of Operations. This transition comes as the former Senior Director of the Medical Device Division, Thomas Stone, JD, will focus on his new role as Vice President of Marketing.
Sarra brings a wealth of experience and expertise. Prior to joining GLOBAL, she held positions at Stryker and Johnson & Johnson, where she gained extensive knowledge and skills in the medical writing field. Her proven track record and in-depth understanding of regulatory standards, particularly in the context of EU MDR compliance, make her the ideal candidate to lead our Medical Device division. Sarra emphasizes continuous process improvement, technical excellence, rigorous project management, and professional growth for all members of the team. We are confident that under her leadership, we will continue to thrive and contribute significantly to our company's mission and our clients’ success.
GLOBAL is thrilled to announce a change to its top leadership positions for the first time in its history. Effective April 1, 2024 founder and CEO Emily Stephens has transitioned to serving exclusively as CEO of Global Exponential Technologies (GxT) and Matthew Longhurst has assumed CEO duties at Global Regulatory Writing & Consulting.
Founded in 2014, GLOBAL is a medical writing company that helps innovators in the life sciences industry deliver new products and devices to market. Rated as one of the top 10 medical writing service providers by Life Sciences Review, GLOBAL has helped over 130 clients navigate regulatory requirements with ease and efficiency. With the launch of partner company GxT in 2022, they are the first in the industry to leverage automation and advanced intelligence software to improve the quality and strategy of regulatory submissions.
Matt has been serving as GLOBAL’s COO since 2018 and has years of experience as an attorney, a CPA, and an organizational leader prior to his time at GLOBAL. “In this new role I look forward to continuing the same focus that has led to our historical success: prioritizing the well-being of our employees above all else,” Matt said. “With a team of best-in-industry talent, we are poised to level-up even further over the next year by adopting a technology-enhanced approach to our work.”
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