In our prior article, we discussed the history and evolution of Medical Affairs departments, and reviewed how these departments have grown to perform so many integral functions within pharmaceutical companies. We also observed that, as Medical Affairs’ work streams have multiplied over time, the need for project management expertise has increased substantially.
In general terms, project managers’ duties in Medical Affairs can be described as helping to free other members of the department to do what they do best. These managers can be tasked with everything from streamlining the work, increasing efficiencies, and overcoming or eliminating obstacles, to anticipating and solving problems, and controlling or reducing costs.
While this may sound demanding, it makes sense when we consider the extensive and essential service that Medical Affairs provides within pharma.
Dealing with complex challenges
Project management in Medical Affairs is complex and challenging work. Project managers are asked to handle dozens of competing demands, required to deal with a myriad of priorities, and they must build and maintain relationships with dozens of individuals at varying levels of authority, both internally and outside the company. Also, project managers typically are asked to meet very specific departmental expectations, yet those expectations can differ significantly from those of the company at large.
And, of course, they must manage within Medical Affairs schedules, which tend to be very tight.
In many cases, departmental budgets can be even tighter.
While maneuvering through this stress-inducing landscape, project managers are also counted on to smoothly and capably accomplish such essential tasks as:
- Assisting with a range of product development activities
- Facilitating and supporting ongoing strategic planning
- Managing the development and execution of annual plans including goals, strategies, and tactics
- Helping work streams and product teams plan, execute, track and report on tactics, including clinical trial development and implementation, advisory boards, publications, symposia, and conference presentations, among many others.
- Administrating and tracking departmental budgets
- Assisting with program and portfolio strategies aligned with product lifecycles
- Implementing tools that connect Medical Affairs with commercial programs while maintaining regulatory discipline
- Coordinating and maintaining relationships with and between Procurement, Finance, Contracting, and external vendors
Organizing for increased effectiveness
Even with their daily focus on implementing departmental tactics, strategies, projects and tasks, project managers recognize the need to carefully organize their own work situations in order to achieve maximum effectiveness. For one example, many project managers serve as the communications hub for the entire department. They keep various work streams continuously informed about the status of individual projects, in detail, while also alerting teams about how their individual projects may impact—and be impacted by—the activities of other areas within the department and other departments within the company.
This kind of multi-level communication responsibility is often a stand-alone function in other organizations. However, in the Medical Affairs project management portfolio, it can be one task among many. Project managers therefore have to prioritize their own time even as they address various departmental and company assignments. This self-organizational imperative must be strategically layered in among the general activities listed above, and also seamlessly interwoven with the execution of many specific tasks, which can include:
- Providing detailed status reports of each major initiative
- Developing and managing the contracting process with external vendor partners, including working with Legal and Contracts teams
- Reviewing vendor proposals and supporting contract negotiations
- Assisting in the planning and development of content for medical congresses
- Working with medical directors to find ways to leverage assets for multiple purposes that meet the needs of the medical community while maximize budget efficiencies while
- Interacting with opinion leaders and other healthcare professionals to: arrange speaking engagements and preceptorships, connect them with internal teams, facilitate introductions to company leadership, and process consulting agreements
- Retaining and maintaining institutional knowledge in the face of departmental turnover
In addition, many project managers are asked to find workarounds for departmental budget challenges, which can mean working across the department to minimizing expenses and maximize resources.
Functioning effectively amidst these varying forces and pressures requires not only a talent for organizing but a deep understanding of subtle aspects of each of the department’s functions and activities.
Anticipating departmental needs
If there is a single characteristic that is likely to make Medical Affairs teams value their project manager, it may be the ability to think ahead. There are always numerous ongoing and often competing demands, and new priorities seem to continually emerge. Since project managers often are asked to help the department unravel problems when they arise, they need to be able to look as far down the path as possible. That way, the manager will have the flexibility to take things in stride.
In short, it helps to stay at least one step ahead of the team, even as the manager remains fully aware of both the big picture and the small details.
To do this, they must get to know each Medical Affairs stakeholder. Project managers must also understand the drug development process, regulatory and compliance requirements, and legal implications. Ideally, they would also become familiar with the product, its clinical data, launch schedule, likely marketing trajectory, and projected lifecycle. When this information is readily available and thoroughly understood, a talented project manager will have an excellent chance to provide value on a daily basis.
You can maximize your project management function
Considering the challenges faced by project management in Medical Affairs, it makes sense to connect with people who know it inside and out. At CMK Select, we have the experience and training you need. In fact we have developed innovative processes designed to keep every aspect of your project management function humming. We are happy to share our expertise, or you can engage our highly-trained, expert staff, but, either way, you and your Medical Affairs department will benefit. Contacting CMK Select will boost your success, now and in the future.