As the head of the Project Management Department, Ellie Chen shares her experience working at HCmed Innovations Co., Ltd. Having worked in HCmed for 6 years, Ellie has reached several milestones that involve a wide range of functions, including regulatory affairs, research and development, and customer management.
1. Please share your working experience.
Before joining HCmed, I had gained some knowledge and lab testing experience that helped me pave my way to become a project manager of developing drug-device combination products. While I majored in electroneurophysiology when studying at the Institute of Biomedical Engineering of National Yang Ming Chiao Tung University, I also attended extensive courses related to regulatory affairs and laboratory study, all of which, along with the experience I gained working as a research assistant at Chang Gung Medical Education Research Centre after graduation, became part of the knowledge and experience I needed for working as a project manager at HCmed.
Joining HCmed as a project manager has allowed me to take on a wide variety of job responsibilities, pushing me to achieve several milestones along the way, first being to receive the CE Mark approval for our product in 2016. After this achievement, a major project that I participated in the following year was the construction of our manufacturing site, which is compliant with the Good Manufacturing Practice (GMP) standards.
As our product continuously obtained regulatory approvals from other countries and as the construction of our manufacturing site had been completed, at the same time, I also became more acquainted with the design and development of our product, which was essential for me to effectively plan and execute future projects.
Lastly, my responsibility also includes coordinating with the clients and negotiating about the requirements of the projects with the stakeholders. All of these milestones forge the knowledge and experience that I have gained along the way, helping me to become more competent and experienced as a project manager.
2. What do you think are the key factors to help successfully move forward a project?
I think the key factor to help move forward a project is to be constant communication with the team as much as possible. By understanding the tasks that need to be done and the problems that each team member faces, a project manager would gain a better insight into how a problem can be solved. We try to identify the obstacles by looking at the bigger picture to solve them and coordinate opinions among different departments. As a project manager, it is important that I keep the team’s effort aligned with what we expect to achieve and make sure that our team is directed to achieve a common goal. This way, we have everyone on the same page for the whole team to move along in accordance with the plan.
3. From your position as a project manager, how do you add value to the projects that you work on?
As a project manager, I am responsible for planning, organizing, and closing out projects, with the priorities being ensuring that these projects are completed on time and on budget. We hold discussions and need to coordinate with different teams at HCmed, with the main purpose being to satisfy our customers and fulfill their needs.
Besides letting the clients trust us and letting them know that our devices can meet their requirements, it is of equal importance that we let our team members feel trusted and valued as well – acknowledging their contributions and letting them know that together as a unified team we contribute to the success of the projects.
4. You have worked in projects involving off-the-counter (OTC) devices and inhalation combination products. What do you think is the biggest difference between these two?
When planning to launch an OTC device, we mainly need to coordinate with the Business Development and Regulatory Affairs teams, ensuring that our devices’ performance meets customer’s expectations and that our devices are in compliance with the regulations.
On the other hand, developing an inhalation combination product would require more involvement of the Research and Development team, needing to ensure the usability and manufacturability of the device.
5. What kind of skills do you think are required to work as a project manager?
Being the head of the project management team, I think that the knowledge I gained and the experience I accumulated made it possible to execute a project more smoothly and easily. As I gain more experience along the way, it becomes easier for me to determine how I should build a project plan and delegate the various tasks in the project.
Other than technical know-how, I think that effective communication is just as an important factor to successfully complete a project. By scheduling regular meetings and giving timely feedback, it not only becomes easier for me to monitor the status of the projects, but it also helps to ensure that our team continuously works seamlessly as one.
