Teams and Resourcing Webinar Series - Webinar 4

Webinar Link

Hello and welcome to the next webinar in our series. My name is Beth Meyer and today I'll discuss a case study in applying effective teamwork across multiple projects. Teamwork can be most effective when you have overlapping projects and a defined pipeline of work. Please check out our previous webinars for information on how to identify a workload and resource it properly. A team-based approach can be a great strategy for tackling a large amount of work. Today's presentation is the fourth in a series examining how teams may

effectively approach the workload associated with supporting a device portfolio under EU

MDR

Here at GLOBAL Regulatory Writing and Consulting, we support Medtech and biopharma innovators with strong collaborative partnerships, tailored regulatory consulting and writing services, and deep strategic expertise.

Before we get started I'd like to tell you how we approach success. GLOBAL has six core values by which we define ourselves and measure our success. Your organization may have different core values and we encourage you to use those or your team's own core values as a lens through which you examine your own success. When our team approaches a problem, we look to those values to help us understand how we may find successful solutions.

Today our discussion of a team-wide approach to multiple projects will really center our core value of agility. One of the keys to our team success is the ability of each team member to quickly adjust to new information or requests and apply creative solutions to problems. Before we dive into the challenges of addressing multiple project changes as a team, I'd like to first set the scene to outline the working relationship that we have with our client. Our client has a large and diverse product portfolio supported by multiple stakeholder and project teams. GLOBAL has been working with this client for several years and our internal team comprises multiple writers all with deep working experience with the project team. The work assigned to us can vary quite a bit with multiple deliverables included within each project and a variety of regulatory strategies are employed with each project.  

Here we can see the original schedule for the team. In this case the team includes a manager who spends about 40% of their time on their own writing projects 40% of their time supporting team member writing tasks and 20% of their time on other administrative tasks. The team also includes three full-time writers where each writer has a workload of about 80% writing and 20% administrative tasks. This team also includes a swing team member who spends part of their time supporting this particular client and the rest of their time supporting another internal team at GLOBAL. This team member also spends about 80% of their time writing and 20% of their time on administrative tasks.  

In this case our client then presented us with several urgent projects that were not part of our original schedule. This included one high priority submission for a new product and two urgent notified body responses. The challenge that our team faced was that our writing team was already near full capacity under the current schedule and we needed to both move our current projects forward and make sure that we address the new needs of our client. So our approach was to lean into our ability to be agile and engage in creative solutions and leverage our strong working relationships and communication with our client to ensure that whatever plan we came up with was appropriate and addressed all needs that their client had. The first step was to assess what our client's priorities were across their entire portfolio. We knew that this new submission and two notified body responses were being treated as top priority and so we wanted to know who from our clients' internal teams were affected. We knew that it was likely that some of our original work was likely to be paused or delayed while our client's internal team worked on these same high priority projects. So knowing how our client's priority shifted allowed to make better decisions and assigning resources with our own team.  

So from our conversation with our client we learned that the urgent submission was being supported by the same project team that was supporting notification projects one and three. From our discussions, we learned that the internal teams were pausing their work

and that they had secured approval for extending the project due dates. Knowing this, we confirmed that our internal team would be able to pause or delay our own work in support of this urgent submission. So based on this we, assigned the urgent submission to our

team manager who had the most capacity and the most experience and we assigned the two notified body responses to writer A. Writer A was able to pause her work because notification 3 was also being paused. However assigning these projects out this way put both the manager and writer A over capacity. They would have to put in a lot of overtime over several months in order to complete all this work. So we had to do some internal assessments to see what changes we can make to support those two writers.

Next we assessed our internal teams capacity. We knew that all of our writers had a little bit of extra wiggle room in their schedules because they originally were scheduled for about 80% writing work and 20% administrative tasks. We knew we could probably bump some of those administrative tasks to other team members within the department. We also thought there was a good chance that that swing writer - the person who was supporting two teams within Global - would be able to provide more support than originally intended. So by discussing with some of our other internal teams at Global we were able to assess what resources would be available for us in this time of urgent need.

So after making those discussions happened, we had our final schedule. So along with our manager and writer a taking on the new urgent projects, we also were able to put in support for additional support with writers B C and S. These writers took on the additional support tasks which could include things like literature screening, article extractions, and data management instead of doing their administrative tasks. This did require a push in workload and effort from all team members but the workload was able to be evenly distributed across all team members. R gular communication between team members at GLOBAL kept the projects moving forward and regular communication between GLOBAL and our client ensured that the client's timelines would be met. Ultimately this workload rearrangement was a little aggressive but it was ultimately successful because we had the right team members working together both internally here at GLOBAL and externally with our client who always demonstrates great agility and creativity when it comes to urgent projects. We also had excellent project management from our writers. Our internal team and the client team were both able to simultaneously manage multiple ongoing projects and support tasks to make sure that nothing was missed with any of the ongoing work.

Finally this aggressive workload ship was successful because of the trust shared within our team at GLOBAL and also between the GLOBAL team and our client team. Internally each of our writers knew they could trust the output of their teammates and externally because of our team's long-standing relationship with our client, all of our team members knew how to do the work. We were able to work effectively efficiently and communicate clearly with our client team and our client team trusted that we would do things the right way.

So that's a focus look at a recent workload we've had at GLOBAL. How might this apply to your organization? Your organization might encounter scenarios in which urgent or escalated projects come up and your team has to adapt the schedule to accommodate the workload. Having a team that can work together and communicate well is essential. When you have a flexible agile team that trusts each other you can maximize efficiency and meet the needs of your portfolio. Ultimately however these projects require strong leadership and excellent communication at the team and project level to ensure that everyone is supporting each other throughout the process. Most importantly this approach can help build a united team so that you can continue problem solving together in the future.

Thank you so much for joining us for another GLOBAL webinar. We look forward to connecting with you in the future. Please visit us on our LinkedIn Pages or on our website to learn more about how our processes can help your team succeed.