There are far too many mediocre Consultants out there. Perhaps their objective isn’t strictly to take up your time and drain your wallet, but that’s what it can feel like. Working in the pharmaceutical consulting arena requires unique expertise that can be passed on through the work performed on a daily basis.
A true Subject Matter Expert (SME) sees things from a different perspective and can open your eyes to a multitude of opportunities. A firm that concentrates in providing SME Consulting services for pharmaceutical compliance must always be ready to jump into a new project with precise skill sets including process development, analytical, formulations, regulatory, quality assurance, and program management. Separating the strong from the weak can be tough, but if you look for these five traits, you’ll find yourself having much more positive experiences with these potentially invaluable resources.
Subject Matter Expert (SME) Consultants often find themselves in positions of leadership within a particular project area. This can be very lonely and challenging work, but for those with a passion, it can be the most rewarding part of the job.
As Consultants continue to take on more projects, deadlines get stricter. This constant challenge can wear down many overstretched firms who offer generalists. However, the best SME’s understand that it’s their ability to discuss the project and confer with both their team and yours when necessary is what makes them so valuable to a company. They are there to make your company better by effectively and efficiently applying their unique skill set—and they understand this is their ultimate responsibility.
Look for a SME Consultant willing to put their expertise to the test even under constant pressure.
The firm that separates themselves from the pack in FDA and regulatory consulting knows how to manage the communication requirements and not just the technical requirements of a project. In addition to providing outstanding technical subject matter expertise in regulatory affairs, drug development, GMP compliance, and the like, a top-notch firm needs to have the resources, tools, and skill-set to communicate with team members over a great distance and listen to the wishes and desires of the client. A motto of top firms is: “There is no such thing as over communicating,” and they take this in stride as they complete any tasks assigned to them.
If your SME Consultant isn’t asking the right questions, that could be a red flag. Don’t feel like you should have to go to them to give instructions, they should always take the initiative.
Some clients in the pharmaceutical industry don’t know exactly what they’re looking for on day one.
Great firms are experts at taking everything in stride and blending into the current project. Expectations can change weekly, daily, or even more than once in a day, but like a chameleon, a quality SME consulting firm needs to have the skills and resources to flawlessly shift their focus and work to create what the client wants.
Great firms relish the opportunity to show how they can adapt to changes, and if they are stuck on past directions and not keeping up with your company, it’s not your job to manage them—but perhaps it’s your job to find someone who will keep up.
It is so easy to get lost in the weeds, and this can be one of the biggest contributors to strained relations between a client and a consultant. Great SME Consultants treat looking at the 30,000-ft view like it’s their job—because it is!
To instill confidence that each step of the regulatory and compliance process is perfect, great firms work on both the small and large picture pieces of the project to guarantee success. Constantly drawing on their breadth of experience from all their projects to apply just the right lessons learned to the project at hand, the best firms always keep the whole project in mind instead of just a detail or two.
SME Consultants in life sciences work for a variety of companies and in a variety of fields. They must be adept at utilizing their expertise in diverse ways from project to project. Even if this is the first time they have done this exact work—because you have come up with a new idea—great firms ensure their SMEs are always assimilating new ideas, information, data, regulatory changes, and new market trends into their knowledge base, so they keep up as easily as if they were in your head.
Unfortunately, not all Subject Matter Expert Consulting Firms are created equally, and the challenge becomes separating those who can help you from those who feel like they’re holding you back. Great firms are a resource for you to draw from and once you find the right match, it will be like a weight is lifted and they’ll help you move forward on all your projects.