WELCOME
The BioPharmaceutical industry ("BioPharm") includes Pharmaceutical, Biotechnology, and Medical Device companies. These companies develop drugs and medical devices to diagnose, prevent, or treat disease.
Some people in the BioPharm industry work directly for a pharmaceutical, biotech, or medical device company; others work for consulting companies like Contract Research Organizations (CROs). Some work in hospitals or doctors’ offices. Some work for Regulatory Agencies like the Food and Drug Administration (FDA). Others are self-employed, freelance consultants.
This website will introduce you to jobs in the BioPharmaceutical industry. We will describe the types of jobs, job responsibilities, and educational requirements. We will also provide links to additional resources.
EDUCATION
Many jobs in the BioPharm industry require medical, nursing, pharmaceutical, or other scientific training but the industry also needs people with expertise in other fields such as Information Technology (IT), finance, law, administration, sales and marketing, public relations, manufacturing, facilities management, and human resources.
Education requirements range from a high school diploma to Associate or Bachelor degrees (AS, BA, BS); Masters degrees in science or business (MS, MBA); and doctoral training in science, medicine, pharmacy, or law (MD, PhD, PharmD, JD, DVM, DDS, etc.).
The BioPharmaceutical industry ("BioPharm") includes Pharmaceutical, Biotechnology, and Medical Device companies. These companies develop drugs and medical devices to diagnose, prevent, or treat disease.
Some people in the BioPharm industry work directly for a pharmaceutical, biotech, or medical device company; others work for consulting companies like Contract Research Organizations (CROs). Some work in hospitals or doctors’ offices. Some work for Regulatory Agencies like the Food and Drug Administration (FDA). Others are self-employed, freelance consultants.
This website will introduce you to jobs in the BioPharmaceutical industry. We will describe the types of jobs, job responsibilities, and educational requirements. We will also provide links to additional resources.
EDUCATION
Many jobs in the BioPharm industry require medical, nursing, pharmaceutical, or other scientific training but the industry also needs people with expertise in other fields such as Information Technology (IT), finance, law, administration, sales and marketing, public relations, manufacturing, facilities management, and human resources.
Education requirements range from a high school diploma to Associate or Bachelor degrees (AS, BA, BS); Masters degrees in science or business (MS, MBA); and doctoral training in science, medicine, pharmacy, or law (MD, PhD, PharmD, JD, DVM, DDS, etc.).
How to navigate this site
I assumed that 3 different groups might look at this site.
- There will be people who already work in the Industry who might find the website and check to see if "I got it right”.
- There may be people who have already targeted a particular job in industry and who are searching for additional information about that job.
- And, there may be people who have little or no experience with the industry but who are looking to learn about interesting jobs.
These three groups will search differently. Groups 1 and 2 will already know something about drug development and they may be aware of common job titles and career paths. Group 3 may not know where to start.
So I have organized the site as follows.
Under the HOME page, there is a page called ABBREVIATIONS that lists abbreviations and technical terms related to drug Discovery, Development or Marketing. Next is a page called BACKGROUND where I will provide some basic information about key regulatory topics such as the role of the FDA, the IND process, filing an NDA, Phases of Drug Development, Clinical Study Reports, etc.
There is a heading called Drugs/Devices where I will outline how the FDA classifies pharmaceuticals, biologics, and devices.
And there is a page called HOW DRUGS ARE MADE that describe the 3 stages of making a new drug or device: Discovery, Development, and Marketing.
The next tabs will be DISCOVERY, DEVELOPMENT, and COMMERCIAL. In each section, I will describe the fundamental activities that occur during the stage and identify the key roles.
For example, under DEVELOPMENT, you will find tabs for Nonclinical and Clinical Development. In Clinical Development, you will get information about Clinical Trials and learn how Medical Monitors, Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), Investigators, Clinical Research Coordinators (CRCs), Biostatisticians, Data Managers, Regulatory Advisors, etc. work together to evaluate potential new drugs in human volunteers and patients. As the site grows, I will add links to pages that describe each of these jobs and the education and training required.
I will also add a section called Multi-Stage for roles that overlap the other sections. For example, jobs in Manufacturing start during DISCOVERY, and continue during DEVELOPMENT and COMMERCIALIZATION. Other roles such as Medical Writing, Regulatory Affairs, Project Management, Public Affairs, Legal and Finance, Information Technology, etc. are needed during all three phases.
I have also add a page called About under the HOME page to describe my experience in industry. I will add information about other contributors here as well.
Disclaimers:
This website is new. I will start by drafting the sections about DEVELOPMENT, then add information about MARKETING, and then discuss DISCOVERY. Right now those sections are empty but I've left some of the headings so you can see what is coming.
It will take me several months to complete all three sections, so if you don’t find the information you want, please check back in a few weeks.
Most of my experience in withing the United States so I will often refer to the FDA and will use job titles that are commonly used in the US.
And, because it is awkward to say "drugs and devices" over and over, I will often use "drug development" as a general term. Initially the website will focus on drug development and I will add pertinent sections for medical devices later.