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Steve Gens

Steve Gens

Steve has over 25 years of experience, primarily in the biopharmaceutical and healthcare industries. After leading many technology and business process initiatives for Waterford Crystal and Johnson and Johnson, he developed an interest in global teams and organizational performance. He moved into consulting where he built and managed several healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. Steve has deep strategy formulation, organization development and performance, global workplace collaboration, industry benchmarking and information management strategy expertise. Steve holds a Bachelor of Science degree in Business Computer Science and a Master of Science in Organization Development with distinction for his field work from American University. He is certified in Change Management from the NTL Institute of Applied Behavior and is a frequent speaker with several publications.

 

Recent Posts


Pursuing World Class RIM Part 4: Authoritative Source and Data Standards Update

Written by Steve Gens in Life Sciences on 03/01/17


Designation of specific RIM systems and repositories as the authoritative source for regulatory information has been the standard for many years as evidenced by our previous RIM research. In 2016 we took the next step towards understanding regulatory information authoritative sources by asking each company to assess their confidence in the data within the authoritative source for 10 essential capabilities.

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Pursuing World Class RIM Part 3: Applying Emerging Technologies in the RIM Space

Written by Steve Gens in Life Sciences on 23/11/16


We have been discussing and anticipating the promise of emerging technology to significantly improve Regulatory Information Management (RIM) systems for the last few years. Historically traditional methods, such as more powerful servers and faster internal networks, shared workspaces and incremental software upgrades have provided relatively little business improvement.
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Pursuing World Class RIM Part 2: Comparing RIM Operating Models

Written by Steve Gens in Life Sciences on 17/11/16


For years, RIM software vendors have talked about the importance of having a common platform or suite of products for successful management of regulatory information. For industry, a “common” capability requires much more than a set of tools. It requires common processes across sites and geographies, standardized data definitions and entry criteria for the information captured within the RIM systems, as well as enforcement of those standards.

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Pursuing World Class RIM Part 1: What is World Class RIM?

Written by Steve Gens in Life Sciences on 08/11/16


Me and my colleagues (Greg Brolund from Chicopee Falls Consulting and Sarah Powell from Powell Regulatory Services) write an annual white paper to provide a clear industry status of Regulatory Information Management (RIM) highlighting the current state, key trends and priorities, investment focus, projected capability and organization change, and a comprehensive update on the provider landscape. This year we have an exciting addition that focuses on defining and measuring World Class RIM.

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