Consultants and Contractors
Is there a difference between a BioPharm consultant and a BioPharm contractor?
Many people define a consultant as a freelance professional who provides specialized expertise to a company. Consultants may be self-employed or be employees of a university, or a consulting group or contract research organization. They may consult one time or several times during a project. They often consult for several companies.
Most people characterize an independent contractor as an outsider who provides ongoing support to a company in place of an employee. A company might hire a medical writer for a project, or a regulator consultant who helps file an IND or NDA. Contractors may or may not do similar work for other companies. Contractors may be self-employed, or employees of a contract research organization, or employees of a staffing firm. I am not aware of any contractors who are university employees but I’m sure there are some out there.
Sometimes is difficult to draw a line between the role of consultant and contractor. Some consultants come in to provide an opinion and then are asked to implement their suggestions, in this case they act like consultant and contractors. Both consultants and contractors are providing expertise and services that the BioPharm company needs but they are not employees of the company.
Look at the list of professions under our table ROLES, all of these jobs, except possibly that of CEO, can be filled by employees or contractors. Large companies hire contractors to provide extra support for big projects or to audition potential new hires. Many start-ups rely on contractors until they are busy enough for full-time staff. I have consulted for some companies that are “virtual companies” where all the work was done by consultants, not employees. In one case, the company did not even have an office, we met at the CEO’s dining room table for the first year.
Most BioPharm consultants have many years of experience in their fields. That is what they bring to the table--expertise. That expertise may have been gained in the BioPharm industry or in a university setting. If you are an academician with specialized knowledge of a disease state, or of a field like pharmacology or epidemiology, your knowledge is valuable. Being a consultant often provides an introduction and entry to the BioPharm industry.
Similarly, being a contractor may provide an entry to a full-time job in a company. Many companies contract with a staffing group to help them recruit potential employees and then hire these people as contractors for a few months to see if they will fit in. In my experience, this happens commonly with Clinical Research Associates and Medical Affairs staff, less commonly with Medical Monitors.
Being a consultant or contractor has pluses and minuses. In theory, you can choose with where and when you want to work. In reality, this is often not the case. Sometimes companies won’t hire you as a consultant if you are also working with their competitors. Or, sometimes it’s feast or famine. You have 3 or 4 consulting offers but these companies all want their projects completed at the same time. Mid December seems to be everyone’s favorite target to get a submission into the FDA before the end of the year! Or, you sit at home playing video games and cleaning out closets for weeks while waiting for the next opportunity. I know a few very talented regulatory consultants who manage to schedule their consulting opportunities around vacations.
In my BioPharm career, I have been a full-time employee of a Pharma company, an employee of two CROs, an independent consultant, an independent contractor, and a part-time employee. Aside from the administrative part of my jobs, my technical work has been similar in all these settings. Both as an employee or medical consultant, I have planned and monitored clinical trials, drafted Investigator Brochures and Final Reports,, worked in Medical Affairs, taught classes, and gone to FDA meetings. The work was similar; how I was paid and where I sat for much of the day was different.
If you become an independent consultant or contractor, you will probably need to find a good accountant to help you plan so you don’t end up with an unexpected tax bill at the end of the year. You will need to pay your Social Security contributions, may need to make estimated tax payments, and may want to contribute to your own retirement plan and buy health insurance. On the plus side, things like home office space, equipment, and some travel costs may be deductible. Think of the exercise as “Paying Yourself and Paying Uncle Sam”.
If you are working for only one company, it may also be difficult to decide if you are an independent contractor or temporary employee. The IRS publishes guidelines to help you, and the company that is paying you, whether you are an independent consultant or a part-time employee. We have provided a link to that IRS document called, “ Independent Contractor (Self-employed) or Employee” under the Resources tab on the page called “Other links”.
As an independent consultant or contractor, you might also need an attorney to help you decide how to structure your consulting business and whether or not to form a corporation or LLC. You might also need an insurance agent if you decide that you need “errors and omissions” insurance. These topics are too complicated for further discussion here but we plan to find some legal, accounting, and insurance experts who can provide advice.
Is there a difference between a BioPharm consultant and a BioPharm contractor?
Many people define a consultant as a freelance professional who provides specialized expertise to a company. Consultants may be self-employed or be employees of a university, or a consulting group or contract research organization. They may consult one time or several times during a project. They often consult for several companies.
Most people characterize an independent contractor as an outsider who provides ongoing support to a company in place of an employee. A company might hire a medical writer for a project, or a regulator consultant who helps file an IND or NDA. Contractors may or may not do similar work for other companies. Contractors may be self-employed, or employees of a contract research organization, or employees of a staffing firm. I am not aware of any contractors who are university employees but I’m sure there are some out there.
Sometimes is difficult to draw a line between the role of consultant and contractor. Some consultants come in to provide an opinion and then are asked to implement their suggestions, in this case they act like consultant and contractors. Both consultants and contractors are providing expertise and services that the BioPharm company needs but they are not employees of the company.
Look at the list of professions under our table ROLES, all of these jobs, except possibly that of CEO, can be filled by employees or contractors. Large companies hire contractors to provide extra support for big projects or to audition potential new hires. Many start-ups rely on contractors until they are busy enough for full-time staff. I have consulted for some companies that are “virtual companies” where all the work was done by consultants, not employees. In one case, the company did not even have an office, we met at the CEO’s dining room table for the first year.
Most BioPharm consultants have many years of experience in their fields. That is what they bring to the table--expertise. That expertise may have been gained in the BioPharm industry or in a university setting. If you are an academician with specialized knowledge of a disease state, or of a field like pharmacology or epidemiology, your knowledge is valuable. Being a consultant often provides an introduction and entry to the BioPharm industry.
Similarly, being a contractor may provide an entry to a full-time job in a company. Many companies contract with a staffing group to help them recruit potential employees and then hire these people as contractors for a few months to see if they will fit in. In my experience, this happens commonly with Clinical Research Associates and Medical Affairs staff, less commonly with Medical Monitors.
Being a consultant or contractor has pluses and minuses. In theory, you can choose with where and when you want to work. In reality, this is often not the case. Sometimes companies won’t hire you as a consultant if you are also working with their competitors. Or, sometimes it’s feast or famine. You have 3 or 4 consulting offers but these companies all want their projects completed at the same time. Mid December seems to be everyone’s favorite target to get a submission into the FDA before the end of the year! Or, you sit at home playing video games and cleaning out closets for weeks while waiting for the next opportunity. I know a few very talented regulatory consultants who manage to schedule their consulting opportunities around vacations.
In my BioPharm career, I have been a full-time employee of a Pharma company, an employee of two CROs, an independent consultant, an independent contractor, and a part-time employee. Aside from the administrative part of my jobs, my technical work has been similar in all these settings. Both as an employee or medical consultant, I have planned and monitored clinical trials, drafted Investigator Brochures and Final Reports,, worked in Medical Affairs, taught classes, and gone to FDA meetings. The work was similar; how I was paid and where I sat for much of the day was different.
If you become an independent consultant or contractor, you will probably need to find a good accountant to help you plan so you don’t end up with an unexpected tax bill at the end of the year. You will need to pay your Social Security contributions, may need to make estimated tax payments, and may want to contribute to your own retirement plan and buy health insurance. On the plus side, things like home office space, equipment, and some travel costs may be deductible. Think of the exercise as “Paying Yourself and Paying Uncle Sam”.
If you are working for only one company, it may also be difficult to decide if you are an independent contractor or temporary employee. The IRS publishes guidelines to help you, and the company that is paying you, whether you are an independent consultant or a part-time employee. We have provided a link to that IRS document called, “ Independent Contractor (Self-employed) or Employee” under the Resources tab on the page called “Other links”.
As an independent consultant or contractor, you might also need an attorney to help you decide how to structure your consulting business and whether or not to form a corporation or LLC. You might also need an insurance agent if you decide that you need “errors and omissions” insurance. These topics are too complicated for further discussion here but we plan to find some legal, accounting, and insurance experts who can provide advice.
