How Project Management Contributes to Pharmaceutical Advancements?

Before a new pharmaceutical product finds its way to a consumer, it has had a rigorous journey. You may know something about the FDA approval process, the packaging, and even the marketing of a healthcare product. However, you may be unaware of the instrumental role of the pharmaceutical project manager.

The pharmaceutical project management team includes the individuals responsible for products being developed on time, on budget, and in adherence with all safety and efficacy guidelines. These healthcare professionals also maintain constant communication with biochemical engineers, researchers, scientists, healthcare consultants, and physicians.

Regardless of the amount pharmaceutical companies decide to invest in its new drug development pipeline, there is no chance of success unless project is effectively managed.

In the pharmaceutical industry, project management team plays big role in managing such complex context due to unique regulatory requirement varies country to country, compliance and quality related needs of the industry. Pharmaceutical companies are now facing a new phase in which there are enormous challenges in the long product-development process. Delivering a new product to the market safely, quickly and cheaply is the best way for them to be successful.

Hence, Project management team become key driver to manage project from its development stage to market activation ensuring product meets its quality, efficacy and safety standards.

“As project manager, I must keep track of countless moving parts,” says Abhijeet Mudholkar, project manager for Reckitt Benckiser Healthcare in New Jersey. Headquartered in Slough, England, Reckitt Benckiser is a global company that develops, manufactures, and markets analgesics, cough and cold, and skincare products.

“I maintain detailed records on the research process from initial trials to approvals and follow all regulatory mandates and corporate regulations,” Mudholkar explains. “A project manager becomes extremely knowledgeable in every aspect of the medication, including every aspect of its efficacy and any side effects.”

Top-tier project managers like Mudholkar are also excellent communicators with solid business sense. These healthcare professionals must be able to pivot with sudden changes, making necessary adjustments to the process as needed.

The critical role of the pharmaceutical project manager

Today’s pharmaceutical marketplace is complex and highly regulated. Here are some of the responsibilities of project managers in this evolving industry.

1. Oversee drug development and approval. Project managers ensure that pharmaceutical projects are well-defined with clear objectives and meet strict timelines and budgets.
2. Coordinate regulatory compliance. The FDA sets and enforces strict regulations. Project managers ensure that all steps of the process comply with these rules.
3. Facilitate communication and collaboration. Project managers work to bridge the gap between scientists, researchers, clinicians, regulatory experts, and other stakeholders in order to keep everybody informed and aligned with project goals.
4. Develop the long-term strategy. Project manager also plays very important role in developing long term strategy to achieve sales and margin growth goals on individual categories. They understand business need and manage the scope and goals of the project, work plans, product launch timelines and implementation strategy ensuring we meet retailers and consumer expectation.
5. Identity and manage risks. Pharmaceutical project managers keep a close eye on any risks to the safety and efficacy of the product and are prepared to make necessary adjustments.
6. Balance resources. The job involves a careful balancing act to ensure that financial and human resources are used most effectively throughout the project.
7. Manage timeline. Delays in any industry are costly, but they can be particularly destructive in the pharmaceutical industry, where delays can affect consumer access to new therapies.
8. Manage and prioritize the company’s portfolio of projects. In a highly competitive marketplace, the project manager must stay on top of the company’s overall goals and strategies for the future while remaining focused on the success of current projects.

Project managers drive innovation

Effective project management helps new medical discoveries reach the public sooner and frequently at less cost.

Using advanced medical technology, project managers keep track of an intricate web of research and development data, marketing and manufacturing information, and strict regulatory guidelines.

“One of the most important jobs of a project manager is to track progress against a timeline,” says Mudholkar, who holds a Master’s degree in Formulation Science from London’s Greenwich University. “We facilitate and coordinate communication between team members, helping keep everyone informed when things can change course rapidly.”

Mudholkar explains that in his role at Reckitt Benckiser Healthcare, he creates and manages a fast-paced contingency plan with different team members assigned to each step of the plan. “We consistently review laboratory progress and update our plan as needed so we are ready for the unexpected changes that can occur in any pharmaceutical project,” he says.

This preparation not only helps the product get to the consumer sooner and more safely, but it also helps save stakeholder time and money.

Project managers facilitate communication

Many of today’s clinical studies are multinational, meaning project managers must navigate through a complicated web of international governmental rules and regulations to deliver projects on time and on budget. Supply chain delays during the COVID-19 pandemic put a new spotlight on the critical role of the project manager in all industries, not the least of which is the pharmaceutical industry.

“Effective supply chain management is critical to business success today,” says Mudholkar. “In the pharmaceutical industry, supply chain disruptions have forced us to meet new challenges that require adaptability, critical thinking, and problem-solving skills.”

Mudholkar stresses the importance of the project manager’s relationships with suppliers and of smooth communication between suppliers, manufacturers, and distributors. “We often have to address and find our way through a maze of logistics,” he explains.

That maze often includes risk assessment, data analysis, scenario modeling, and collaborative problem-solving to manage timeline expectations and ensure the success of a product.

“No one day is the same for a pharmaceutical project manager,” Mudholkar concludes.

“Ultimately, we keep our focus on the consumer and how each step of what we do will benefit them.”

Written by Tricia Drevets