Regulatory Affairs teams are increasingly investing in technology, but too many fail to reap the expected benefits because they don’t address the “people side” of change. Without thoughtful engagement, stakeholders may lose faith in the solution. During a recent conference hosted by DIA, a global association of life sciences and healthcare professionals, a panel of executives from Merck, Bristol Myers Squibb and Grant Thornton discussed winning ways to enable Regulatory change. Panelists drew on their deep Regulatory transformation experience to share three fundamental yet often overlooked strategies to dramatically improve outcomes. Companies taking a deliberate approach to change enablement are much more likely to shorten learning and adoption curves, and maximize expected benefits.
A common theme among the panelists’ experience was the vital role of establishing trust within the stakeholder community throughout the Regulatory initiative. Trust, they agreed, is built on two-way communications, which begins with a clear, transparent explanation of objectives, expected benefits, and impacts. Leveraging change agents and providing frequent opportunities for bidirectional feedback during the initiative establishes an environment where trust thrives and culminates in a successful implementation.
3 fundamentals of change enablement
1. What’s in it for them?
It’s a journey
“The case for change has to be made personal.”
Sophisticated tools such as AI represent major leaps forward in an increasingly complex regulatory landscape. But on the people side, there’s no shortcut to adoption. Success relies on consistently using foundational change management tactics throughout the project, rather than waiting until implementation to consider what stakeholders need. Early in the project, work to understand who will be impacted by a change and how, and ensure that those who’ll be impacted are clear about why the project is necessary — and what’s in it for them.
Amy Flynn, leader of Life Sciences at Grant Thornton, emphasized the importance of “providing a realistic description of how the change will improve day-to-day work.”
“Be clear about both the problem and the vision up-front.”
“Agreed,” said Laura Campbell, Merck’s associate vice president of Regulatory Affairs. “Be clear about both the problem and the vision up-front.” She offered an ongoing initiative as an example. Her team set out to improve the processes and underlying technology that support Merck’s end-to-end product labeling. They began with identifying the pain points in a largely manual effort. “Within the labeling space, updates drive many downstream efforts including the potential for artwork and supply chain activities, as well as promotional material updates across markets. We engaged a broad set of stakeholders for input, knowing we don’t all see a problem in a singular way — there are many lenses and perspectives.” The team also kept a pragmatic focus. “While aspirational goals and vision are critical, ultimately you have to be realistic and understand the changes in a concrete way. Use cases and pilot successes went a long way in connecting to the users, addressing their pain points, and laying the groundwork for value. By utilizing automation and connecting data across our source systems along with simplified and streamlined labeling processes, we were able to have a big impact on compliance, traceability, transparency and efficiency.”
Bristol Myers Squibb Global Regulatory Collaboration & Service Center Associate Director Talia Ben David shared an example, as well: “To establish online structured channels for global to communicate with the international markets, we used a well-defined online tool that included all specifications and options ahead of time and in one place. This relatively simple approach enabled us to reduce the number of email correspondences, to have a better status visibility and to increase our efficiency. As a result, our patients are supported in a more timely manner.”
2. Building alliances through sponsors and local experts
Regulatory initiatives often involve stakeholders from many different departments because of the central role that Regulatory Affairs (RA) plays in an organization. Making connections with senior leaders and with those doing hands-on work is essential to alignment and trust. Creating these alliances is often a two-pronged change enablement approach. Sponsors are vitally important to championing change at all levels — building support with their peers and demonstrating active leadership. Local experts, SMEs, play an equally important role. Their ability to grasp the intricacies and answer questions creates confidence that the implementation team understands the details across diverse teams and geographies. These experts make the change real for teams.
Ben David explained that at her firm, SMEs who are experts in their professional function and strong communicators have been effective change agents. According to Ben David, these experts advise the Regulatory team as well as other groups, and provide much-needed support both formally and informally.
“Some people find it difficult to accept changes. It helps them to know that sponsors and change champions are there for support.”
Regulatory audiences prefer having the facts up-front. Both sponsors and SMEs convey a sense of security that the direction is right even if some details are unknown at the beginning. They create an environment in which stakeholders believe information will be shared transparently as it becomes available.
This is how it works at Bristol Myers Squibb, said Ben David: “It helps them to know that sponsors and change champions are there for support.”
3. Keep listening
The complexity of RA environments means that RA transformations are more challenging than most. During the entire project, it’s important to keep listening for clues from stakeholders about their level of buy-in. Individuals accept change at their own pace, but we need to watch carefully for signs that adoption is slipping backwards or important details may have been overlooked in the solution. Focus groups, pilots and feedback surveys or pulse checks can provide clues. The skip-level meeting is another important tool to gain mutual understanding. In these meetings among managers and the direct reports of the next manager down the line, the people impacted by the change can express invaluable opinions. Connecting with on-the-ground users can ensure understanding on both sides — those in charge of the implementation and those who’ll put the technology to use.
“It's important to create an open environment and regularly engage colleagues. Hearing perspectives and viewpoints through the use of skip levels is so important,” said Campbell. “I've learned that an intimate session, under 10 people, fosters an environment of dialogue and exchange.”
“You want to get the viewpoints on the table. Ask three questions: What's working well? What's not working well? And if you had a magic wand, what would you want to happen? It’s about acknowledgement and engagement on the journey. Skip levels can be an incredibly useful tool — building trust and credibility, as well as a sense of joint ownership.”
Ben David concurred that ensuring inclusiveness is critical: “One of the elements of success is getting everybody — stakeholders and SMEs — involved throughout the process. We need to have the key opinion leaders with us.”
In an era of dramatic technology advances, we’re tempted to look for the quick fix. But managing the people side of change is more a journey than a silver bullet. Trust and buy-in won’t happen overnight. And while the technology solution may be impressive, your transformation won’t be successful if people don’t understand it or have confidence in it. Building trust from the start of your project, and consistently communicating and engaging people throughout the initiative is the best path to strong solutions, more complete adoption and more robust benefits.
Leader, Life Sciences
Grant Thornton LLP
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