Meet Jessica, an Associate Project Director guiding trials through the complex regulatory landscape

What does a day in the life of your role look like?

In my role as an Associate Project Director, I am responsible for the comprehensive management of multiple projects focused on Food and Drug Administration (FDA) submissions, ensuring they align with and exceed both the clients' expectations and industry standards. A typical day involves a meticulous review of project statuses, deliverables, timelines, and potential challenges.

I maintain close communication with both project leaders, monitoring the progress, quality, and risk factors associated with each project. This collaborative approach allows for timely adjustments and proactive problem-solving. Beyond ongoing projects, a significant aspect of my role involves the creation and delivery of detailed proposals to both new and existing clients. These proposals outline the scope of our services, required resources, and associated costs. Subsequently, during bid defenses, we present these proposals to clients, ensuring clarity and alignment on project expectations.

Furthermore, I play a pivotal role in fostering collaboration across departments and stakeholders, ensuring seamless coordination and alignment of expectations throughout the organization. Staying abreast of the latest trends and developments in the FDA submission field is a priority. I actively seek out best practices and incorporate them into our processes to enhance efficiency and elevate outcomes.

In essence, my role is dynamic and multifaceted, encompassing project oversight, client engagement, proposal development, interdepartmental collaboration, and a commitment to staying at the forefront of industry advancements for continuous improvement.

What part of your job are you passionate about and would like to share?

One of the most fulfilling aspects of my role is the opportunity to positively impact the lives of patients and instill hope in them for potential cures and successful clinical trials. A key focus of my passion lies in upholding the highest standards of compliance and regulation, ensuring the safety and integrity of every patient involved.

My personal journey with Ankylosing Spondylitis, an autoimmune condition affecting joints, serves as a profound motivator for my career in this field. Having experienced firsthand the challenges posed by this condition, I am deeply committed to contributing to advancements in drug development. Witnessing the transformative power of new medications in my own treatment journey, such as transitioning from injections to pills and from daily to weekly doses, has been a powerful inspiration.

Being part of the impactful work that improves the lives of individuals facing conditions like mine is a source of immense pride. It reinforces the significance of our collective efforts in making tangible differences in the healthcare landscape. This personal connection to the cause fuels my dedication to ensuring that our work not only meets but exceeds the expectations of patients, embodying the very essence of what drew me to this meaningful and impactful career.

What skills are needed to be successful within your team?

To excel within my team, a set of essential skills includes robust project management capabilities, time management skills, attention to detail, strong analytical acumen, and effective communication. Additionally, a profound understanding of FDA regulations and guidelines is crucial to navigate the intricacies of our work successfully.

How do you work With Heart™ and what does it mean to you?

Working 'With Heart' to me involves infusing passion, energy, and purpose into every aspect of my work. It goes beyond the visible outcomes, as I consistently consider the broader impact of my contributions. Operating with integrity, excellence, and compassion, I find genuine joy in what I do, allowing my enthusiasm to drive my professional endeavors. Moreover, a key element of 'Working With Heart' is inspiring others to discover their purpose and supporting their success in our shared professional journey. By fostering an environment of encouragement and empowerment, I aim to contribute not only to the success of our collective goals but also to the individual growth and fulfillment of my colleagues. In essence, 'Working With Heart' is a commitment to genuine dedication, a love for one's work, and the uplifting of others in their pursuit of purpose within our shared career.

What makes Parexel unique?

Parexel stands out as a distinctive workplace, offering a supportive community and an unwavering commitment from its management to my personal and professional success. What sets Parexel apart is its genuine concern for my mental well-being and overall happiness within the workplace, consistently prioritizing my needs.

This unique culture is reflected in the emphasis placed on opportunities for continuous growth and learning. Parexel not only provides avenues for professional development but also encourages engagement in meaningful and impactful projects. The organization's dedication to fostering a nurturing environment, coupled with its proactive approach to putting employees first, creates an unparalleled experience that I haven't encountered elsewhere in my career.

How has Parexel supported your career growth?

Parexel has played a crucial role in fostering my career growth by placing a high value on my ideas and contributions while consistently acknowledging my achievements. The organization's flexibility and support for my preferred work style, whether I seek more guidance or autonomy, have been instrumental in creating an environment where I can thrive.

Furthermore, Parexel has actively facilitated my professional development by providing opportunities to refine my skills, expand my knowledge, and take on new challenges. This commitment to empowering employees has been pivotal in shaping my career trajectory.

Has there been a project you've worked on that has been rewarding?

I've had the privilege of contributing to a project that holds immense personal reward for me. This particular endeavor involves an orphan drug designed for pediatric patients facing a dire prognosis, with no existing cure and a limited lifespan extending only to adolescence. What makes this project especially meaningful is that it marks the pioneering trial for a groundbreaking drug—the first of its kind dedicated to offering hope to these vulnerable patients. Being part of a team working towards providing a potential solution for individuals facing such significant challenges is deeply fulfilling.

The prospect that this drug, through its development and successful trials, could one day be the beacon of hope for these patients and their families is both humbling and inspiring. It goes beyond professional satisfaction; it resonates with a profound sense of responsibility and privilege. Knowing that our collective efforts have the potential to make a lasting impact on the lives of these individuals fuels a genuine sense of purpose and dedication.

Contributing to this project isn't just about professional achievement; it's about making a meaningful difference in the lives of those who desperately need it. This unique opportunity reinforces my belief in the transformative power of pharmaceutical research and the positive impact it can have on individuals, families, and communities.

How do you value Parexel keeping the patient at the heart of everything we do?

Parexel's unwavering commitment to placing patients at the center of our mission is not merely a slogan; it is a deeply ingrained core value embraced by every member of our organization. This commitment permeates our company culture and work environment, shaping the very essence of how we operate.

At Parexel, prioritizing patients is not just a directive; it is a way of life for each employee. This shared dedication is evident in our daily practices, extending beyond words to influence our actions and decisions. We understand that the work we do has a profound impact on people's lives, and this understanding is reflected in our relentless pursuit of excellence.

Our commitment to keeping patients at the heart of everything we do enables us to deliver results that are not only scientifically robust, but also deeply meaningful. This patient-centric approach permeates all aspects of our work, from research and development to clinical trials and beyond. It fuels our passion to make a positive difference in the lives of individuals, emphasizing the real-world impact of our contributions.

How does your team support flexibility and work-life balance?

One key aspect of our work culture that promotes a healthy work-life balance is flexibility. It's not about adhering strictly to the clock or scheduling unnecessary meetings. Instead, there's an emphasis on understanding the nature of the work and allowing team members the autonomy to manage their time effectively. My line manager encourages taking time off when needed and advocates for flexibility within the workday. This is particularly helpful during periods when I find myself putting in extra hours or attending late-night meetings due to client time zones. The understanding and support for time off or adjusted schedules contribute significantly to maintaining a work-life balance. Moreover, the team culture fosters a sense of collaboration and mutual support. When I'm out of the office, there's a seamless backup system in place, eliminating the need for constant connection or carrying my laptop on days off. This collective approach ensures that everyone can recharge when necessary, without compromising the overall team's productivity and effectiveness.

How do you feel empowered and accountable?

I feel empowered and accountable at Parexel in several ways. The company's culture encourages and values creativity, allowing me the freedom to explore innovative and out-of-the-box solutions for our clients. In the consulting realm, it's often necessary to think beyond traditional approaches, especially when engaging with regulators, and Parexel not only accepts but encourages this mindset, fostering a genuine sense of ownership. The trust instilled by the company is a key factor in this empowerment. Knowing that my ideas and contributions are valued creates a sense of confidence, enabling me to take initiative and tackle challenges with conviction. This trust empowers me to navigate unconventional paths when needed, contributing to a dynamic and adaptive work environment. However, it's crucial to balance this empowerment with a strong sense of accountability. In our line of work, where confidentiality is paramount, a small oversight or hasty sharing of information can have significant consequences. Parexel's emphasis on caution serves as a reminder to handle confidential information with the utmost care and thoughtfulness, reinforcing the accountability required in our roles.

How do you see our core value "Respect" in action within the company and your team?

I've witnessed the core value of 'Respect' in action both during the hiring process and within my team at the company. Right from the initial stages of recruitment, I was treated with utmost respect. The hiring experience was characterized by clear communication and transparency; I was neither ghosted nor left in the dark about the next steps. This respectful approach conveyed a genuine acknowledgment of me as an individual rather than just a resume. As I transitioned into a member of the team, it became evident why this culture of respect contributes to the team's accelerated growth. Within the team, mutual respect is not just a stated value but a lived reality. Colleagues actively recognize each other's contributions, fostering an environment where diverse perspectives are valued. This creates a collaborative and inclusive atmosphere, which I am genuinely very happy to be a part of.

How does your team take quality seriously?

Our team places a paramount emphasis on the quality of our work, recognizing its direct impact on crucial agency decisions. The meticulous attention to detail is not merely a standard practice but a necessity, as the quality of our submissions can influence a go or no-go decision from regulatory agencies. Clients entrust us with the responsibility of delivering the highest quality work, particularly for submissions to the FDA. This trust is not taken lightly, and it propels our commitment to maintaining exceptional standards in every aspect of our projects. Similarly, the FDA, as a key stakeholder, relies on the quality of our submissions, and our team is dedicated to upholding the trust and confidence vested in us. By understanding the significant implications of our work on both client relationships and regulatory outcomes, we foster a culture that takes quality seriously. This approach ensures that our team consistently delivers work that not only meets but exceeds the expectations of both our clients and regulatory bodies.

Why did you choose the Clinical Research industry?

Working in this field, I have the opportunity to engage with multiple submissions spanning various indications and products, collaborating with different clients simultaneously. This diverse exposure sets the clinical research environment apart from the sponsor side, providing an immense breadth of experience.

Being a part of the Clinical Research industry puts me at the forefront of innovation. In this role, I am involved in the early stages of drug development, witnessing the journey of new molecules from Investigational New Drug (IND) submissions to New Drug Applications (NDAs) and eventually reaching the market. This process, where all the action happens for drug developers, is not only intellectually stimulating but also personally rewarding as it contributes to advancements in healthcare.

The ever-evolving nature of clinical research keeps me engaged, and the unique challenges and opportunities it presents align with my passion for staying at the cutting edge of pharmaceutical development. This industry allows me to make a meaningful impact on bringing new treatments to the market and improving the lives of patients.

Are there any habits, behaviors, or beliefs you find to be helpful in your everyday personal and work activities?

• Strive for excellence with flexibility
• Cultivate positive understanding
• Foster a culture of setting everyone around me up for success

What do you enjoy outside of work?

Outside of work, I find joy in travelling and savoring the diverse cuisines each region has to offer. Traveling provides me with the opportunity to immerse myself in different culinary experiences. Additionally, I enjoy staying active through Pilates, finding it not only beneficial for my physical well-being but also a great way to unwind. One of my favorite pastimes is baking; I am an avid baker and love experimenting with new recipes. Something most people don't know about me that would surprise them is that I have a karaoke machine set up in my home and I may have a couple of baking videos on Youtube.