When it comes to accelerating operational efficiency in the global sphere of life sciences and healthcare technology, one name that consistently emerges at the forefront is Prasanna Shroti. With over 15 years of extensive experience in managing on-premises and cloud-based products, Shroti has time and again proven his prowess in his field.
Adept at strategizing complex projects involving multiple stakeholders across various geographies, Shroti’s strategic vision, excellent communication skills, and an innovative mindset set him apart. From steering the successful implementation of complex regulatory document management systems to developing high-tech solutions such as virtual reality tours for manufacturing plants, his accomplishments paint an impressive portrait of a leader dedicated to technological innovation. But Shroti’s journey doesn’t end at success; he continuously strives for understanding and adapting himself to more advanced techniques like machine learning, always staying a step ahead in his industry.
As we delve deeper into the labyrinth of operations, strategies, and solutions Shroti has conceived and delivered, let’s explore how this consummate professional continues to leave his indelible mark on the life sciences and healthcare industry.
Essential software suite for day-to-day operations at Gilead
A master at integrating processes and systems in highly regulated environments, Prasanna Shroti operates with precision and strategic acumen when it involves managing day-to-day operations at Gilead Sciences. His approach gravitates around choosing the best software suites to streamline workflow and optimize productivity within the company.
“Our philosophy is to always use the best software mix that enables our scientists and other user bases to put medicines quickly in people’s hands. This generally involves using the best of breed proprietary software for uses that are, broadly speaking, standard across the industry such as product registrations, archiving submissions, study management, and so on,” explains Prasanna.
Despite the appealing selection of ready-made solutions available in the market like Vault’s series from Veeva systems,or the CARA platform by Generis Knowledge Management Inc., Prasanna recognizes the need for customization in some contexts. A keen advocate of tailoring tools to needs, Prasanna understands the value of customized software for certain unique workflows within Gilead.
In situations where industry-standard software may lead to inefficiency, Prasanna seeks to develop and implement bespoke systems. These can range from work planners, trackers to authoring plugins for Microsoft Word, underlining the importance of adaptability in Gilead’s technology strategy.
When handling project management, Prasanna balances traditional approaches with modern solutions. Whether it’s Microsoft Project or more innovative platforms like Monday.com, he weighs the value of these tools against their compatibility with Gilead’s current infrastructure.
This careful balance of interoperability and function reflects the importance of “landscape thinking” – the ability to visualize and manage the interplay between various system components. Prasanna’s approach combines operational efficiency with strategic vision, utilizing overlapping technology solutions to create a cohesive, effective workflow. This allows Gilead not just to stay compliant in a demanding regulatory environment, but also brings life-saving medications to people’s hands more swiftly and efficiently.
Transformative changes in operational processes
For Prasanna Shroti, superior operational efficiency isn’t just about performing tasks smarter and quicker. From his role as an Associate Director at Gilead Sciences, he maintains an unwavering focus on the “big picture,” a virtue that effectively sets the tune of his operational strategy.
“One of the greatest transformations I’ve achieved is the shift from short-term priorities to a broader, “North Star” perspective. We often become so engulfed in the urgency of tasks that we lose sight of what is truly important,” asserts Prasanna. In his work, Shroti seeks a perfect balance, prioritizing larger goals without completely sidestepping pressing tasks.
Working as the backbone of their Regulatory Information Management systems, Shroti skillfully manages a myriad of tasks ranging from complex document management to technical oversight of regulatory applications. Yet, he never lets the rush of the immediate distract him from the compelling vision he adamantly follows – the “North Star.” This “big picture” spearheads his everyday activities and engagements with his team.
His nuanced understanding of critical communication frequencies within the team is remarkable. “Increased communication has been a significant factor in ensuring we all work toward the same priorities and goals,” he concisely points out. While this redirection of focus has yielded operational transformations within his team, it has also reshaped interactions with stakeholders.
From micro to macro
A self-proclaimed master at detail, Prasanna Shroti is no stranger to focusing on the granular aspects of his work. However, it’s his ability to seamlessly shift from the micro to the macro that truly sets him apart. Shroti understands that any effective system needs not only to perform its intended function but to integrate harmoniously with the larger systems within the organization.
He explains this mindset, stating, “Assess processes, and see how well they align with the existing application landscape. Is there a misfit we could be addressing?” His tactful questioning involves examining every step of the workflow to identify any friction points and, if found, works brilliantly to create a seamless integration from the ground up.
One of Shroti’s ongoing goals has been to ensure effective data governance. He believes that the correct utilization of information can fortify company-wide efficiency and the overall operational environment. As part of this effort, he often navigates the complex maze of compliance, ensuring all systems meet stringent regulatory governance. “Do we need to put in an effective Data Governance model for these pieces to fit together?” he adds.
Understanding the market shifts, regulatory guidelines, and technology landscape evolution, Shroti leverages his strategic foresight to stay ahead of the curve. In his quest for operational efficiency, he remains up-to-date with peer developments and vendor offerings, ensuring his decisions are sound, strategic, and ultimately beneficial to Gilead.
The power of eloquence
In the intricately nuanced field where regulations shape the business landscape, effective communication stands as a cornerstone.
“Communication skills are extremely, extremely important in any job, but even more so in this job because the task is not only to come up with an architecture that can last for a long time but also to articulate and explain this architecture, both internally, within our team for execution, and to important stakeholders for their buy-in and confidence as we execute on this roadmap. This is also a very critical skill that comes into the picture when it comes to conflict resolution and prioritization as is bound to happen when working with multiple functions and stakeholders,” Shroti says.
His passion for optimizing communication took root during his student years, participating in activities like debate competitions and extemporaneous speaking. His career at Gilead Sciences further refined these skills, working with some of the world’s finest communicators.
Shroti, who has moved up the ranks at Gilead over nine years, knows firsthand that robust and clear communication within a team often determines the success of projects. This skill is essential in maintaining harmony among stakeholders while ensuring that everyone stays on the same page throughout a project cycle. According to him, good communication is the key to conflict resolution and prioritization of tasks, especially when dealing with multiple functions and stakeholders.
When the conversation turns to his capacity to articulate his thoughts effectively even to an external audience, the accolades speak for themselves. Shroti proudly shares that he scored a perfect 9.0 on the International English Language Testing System (IELTS) without any preparatory measure.
Prasanna Shroti’s eloquence, honed over years of impactful projects, helps him maneuver complex regulatory waters and leads to successful results. He proves that in an industry dictated by rules and adherence to strict standards, the power of communication cannot be understated.
Tips on effective negotiation and communication
Coming from a technology and product management background, Prasanna understands that successful negotiation starts with an open mind. “The advice that I would give is to always go in with a very open mindset without any preconceived notions or biases,” he says. His ethos is to approach each interaction objectively, allowing for more productive, unbiased dialogues, thereby promoting effective decision-making.
Understanding differences in perspective is fundamental to managing stakeholder dialogue, particularly in the highly regulated pharmaceutical industry. To demonstrate this, Prasanna shares, “In most initiatives and situations, people generally work toward the same objectives but have different perspectives on how to get to the end.”
When navigating these discrepancies, Prasanna places immense value on the role of accurate and relevant data. He emphasizes that data, particularly when presented through a single, comprehensive dashboard, can serve as a common ground for effective communication and conflict resolution.
During negotiations, Prasanna advises keeping the end goal in mind and empathizing with the perspectives of others. The idea is to step into their shoes, understanding their standpoint, ensuring mutual respect, and contributing constructively to the dialogue.
Prasanna’s guidance reflects his overall vision – to unabashedly foster openness, constructive dialogue, backed by data, for improved decision making. It underlines his strategic leadership skills, which have ensured Gilead Sciences’ regulatory information systems’ smooth functioning, thus contributing to the pioneer’s relentless pursuit of bringing lifesaving medications to those who need them.
The future of RIM
As digital disruption becomes the order of the day across various sectors, Prasanna Shroti delineates a transformative future on the horizon for Regulatory Information Management (RIM). Shroti envisages upcoming technologies like Artificial Intelligence and Generative AI, playing pivotal roles in shaping RIM’s future.
The current trend in the industry veers toward the consolidation of RIM solutions toward SaaS vendors. However, Shroti envisions that the future of RIM transcends far beyond the conventional realm. He foresees AI-inspired solutions replacing the manual, time-consuming, and repetitive tasks associated with extensive documentation integral to regulatory submissions. Here, the primary drive is ensuring efficiency and precision while mitigating the risk of human error.
“Management of Regulatory Information can be made easier and lead to technology evolution,” Shroti reflects. He envisions Large Language Models (LLMs) as game-changers in the context, using the degree of repeatability in regulatory documentation to generate accurate and consistent results swiftly. LLMs wield the potential to grasp the complex nuances of regulatory terminologies, thus, paving the way for software solutions that can not only comprehend but also generate regulatory text.
The future underlines a revolutionized RIM landscape where compliance meets proficiency bolstered by AI technologies. Shroti’s vision encapsulates the desire for a suite of AI tools that can naturally replicate human articulation of regulatory information, revolutionize document management, and drive operational efficiencies at a scale unimagined so far. As Shroti forecasts, this confluence of regulatory affairs and advanced technologies paints a promising future, prompting the creation of companies ready to explore and adapt to these uncharted technological horizons.
Redefining the field
A common misconception about Regulatory Information Management (RIM), as in many specialized fields, is its perceived inaccessibility. Viewed as a niche corner of the pharmaceutical and biotech industry with high barriers to entry, it has often been overlooked by the broader technical and startup communities. However, Prasanna Shroti proposes a drastically different perspective. “While it is certainly true that RIM has its own niche knowledge and requirements, it is also a massively developing market with a great need and appetite for innovation,” he emphasizes.
Shroti believes that this open call for innovation is breaking down perceived misunderstandings and barriers. He encourages the tech community to realize the rewarding opportunities RIM offers, both financially and in terms of potential societal impact. He reminds us that the work in this field directly influences the speed at which life-saving medicines reach those in need.
Over his years in the industry, Shroti has observed an intriguing evolution in RIM. The rise of Artificial Intelligence (AI) and other disruptive technologies have revolutionized and streamlined operations in unprecedented ways. He enthusiastically highlights that, “with the advent of Artificial Intelligence (AI) and other related technologies, there has never been a better time to get started in this field.”
By applying these technologies, professionals in RIM are not only able to address industry-specific challenges but also contribute to advancing the wider tech landscape. In debunking misconceptions and charting the evolution of RIM, Shroti’s insights deliver a persuasive call to arms for tech innovators everywhere. The challenges and opportunities presented by RIM are not to be ignored; they provide the spark to ignite future progress within the biotech industry and beyond. The message is clear – do not underestimate the potential and dynamic nature of RIM.