Your First Pharma Job

The Regulatory Science program at the University of Southern California offers a variety of graduate certificates, a Masters program, and a new Doctorate geared towards regulatory affairs professionals. In the Regulatory Science program, students learn how to guide medical products and foods through the complex regulatory and reimbursement paths required to bring them to market. Regulatory Affairs is an incredibly important part of the drug development process, and in a very real sense plays the key role in determining the success or failure of a drug development program. Ultimately, it’s a company’s regulatory affairs team that must make the case to the FDA that a drug is safe, effective, and deserves to be on the market.

The program has posted a PDF scan of a great article on regulatory affairs careers from The Scientist, which is usually only available by subscription. The article, “For the Hottest Jobs - Go Regulatory”, follows a typical day in the life of a regulatory affairs associate, Joan Kwong, who started her career in the laboratory and made a career switch a few years later. The article offers some great insight on career potential and typical salary ranges.

The article also includes a sidebar piece entitled “So you want to be a regulatory affairs professional - here’s how to get started”. The article notes that one of the hardest things to get used to at first is the abundance of industry-specific jargon and acronyms. A great resource for learning the language of clinical research and regulatory affairs is the online glossary hosted by the Applied Clinical Trials journal.  ACT also recently posted an interesting article, “eSubs and eCTD and RPS, Oh My! ” which discusses some of the changes regulatory teams are dealing with as the submission process goes electronic.

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Here in Toronto, the MaRS Discovery District is a biotechnology research hub that was specifically developed to connect the science, business and finance communities.

If there is a biotechnology hub like this near you, it can be a great resource for your job search. MaRS frequently holds events and seminars that allow students and interested members of the public to learn more about all aspects of the biotechnology sector.  One series of lectures, called Entrepreneurship 101, is especially useful for getting a behind-the-scenes look at what’s involved in the operation of a biotech business.

Not in Toronto?  Never fear!  The Entrepreneurship 101 lectures are available for free online as webcasts.

This particular session, “Managing your Career - how to sell yourself and manage your career goals“, is of particular relevance for this blog. Teresa Snelgrove, an executive recruiter specializing in the pharmaceutical and biotech sector, and Frederic Sweeney, a scientist who left the lab to start a career in finance, both share insights into the job search and career development.

You can view the webcast here, and download a PDF of the presentation here (requires a free slideshare registration).

A webcast of a previous version of the same presentation can be viewed here.  You may also want to check out the full archive of Entrepreneurship 101 presentations.

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A thorough knowledge of good clinical practice is essential for landing a job as a clinical research associate, assistant, or coordinator.

Instead of paying a lot for an online ICH-GCP training program, you can learn what you need for free from these video seminars.  The site provides a series of lectures covering various aspects of the GCP guidelines.  It was designed to train physicians in South America and it’s affiliated with Pfizer and MIT, so you can trust what they tell you.  The only bad thing about it is that you’ll need to install RealPlayer (or the Real Alternative codec pack).

Here are the lecture topics:

• Clinical Research: An Overview
• Historical Development of International Regulations in Clinical Research
• Overview of the ICH GCP Guidelines
• The Institutional Review Board/The Ethics Committee
• Informed Consent
• Phases of Drug Development
• Clinical Trial Design
• Basic Concepts in Applied Statistics
• Publishing Clinical Trial Results
• Evaluation of a Clinical Research Site
• The Protocol as a Clinical Research Tool
• Trial Documents
• The Responsibilities of Conducting a Clinical Trial
• Clinical Supplies Management
• Safety Reporting Responsibilities
• Guidelines for CRF Completion
• Trial Monitoring
• Audit of a Clinical Trial Site
• Clinical Research in the 21st Century: Areas for Future Research
• ICIC: A Model of a Private Health Institution for Clinical Research

And here’s the link: Good Practices in Clinical Research.

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This is a subject that really makes me angry.  If you’re reading this site, it’s probably because you are anxious and hopeful, perhaps even desperate to find your first job in the pharmaceutical industry.  Unfortunately, there are a lot of people out there who are willing to prey on that desperation and take advantage of job-seekers.

A common way to do this is to offer ‘training programs’ of dubious value, usually offered online at a cost ranging from hundreds to thousands of dollars.  I’m aware of a number of these courses related to specifically clinical research and so-called ‘CRA training’. These courses will provide you with some information about ICH-GCP (which you could have found online for free), give you some online ‘exams’ (which you can often retake as often as you like) and in the end, give you a ‘certificate’ that you can print out and proudly reference in your resume.  What you don’t know is that industry recruiters are well aware of these scam companies, and the only thing that these certifications will indicate is that you were gullible enough to be taken in by a con artist — probably not the impression you wanted to make!

The most disgusting of these scam companies has created a whole empire of sham companies and organizations, building a web to lure you in.  They have a phony recruiting company, a phony industry association, and several phony ‘biotech companies’ and CROs.  These sham organizations will post fake job advertisements promising entry-level opportunities in clinical research.  When you apply, you’ll get an email telling you that sorry, you aren’t qualified, but you should consider taking a online training program, which they’ll happily refer you to.  If you’re ‘lucky’, you may even be told that you qualify for a special ’scholarship’, offered by the phony industry association.

I don’t know why the guy behind this scam hasn’t been busted and hauled off to prison.  He’s probably scammed hundreds of thousands, if not millions of dollars out of desperate job seekers, many of them new immigrants, over the years.

Why aren’t more people aware of this scam?  Well, part of it is that the head of this operation seems to be litigious.  Many discussions about Clinical Research Training programs over at Indeed.com refer to the program, but critical comments are mysteriously removed after the ‘CEO’ of this company posts to ‘respond to his critics’.

If you read enough of these forums, you’ll find that a lot of people are taking these courses, and many of them will even recommend them.  Some of these sound like shills to me… if you’ve created a phony training program, creating phony supporters isn’t that much more difficult.  Others sound like genuine people who don’t want to admit that they’ve invested more than $1000 in a program that won’t help them get where they want to go.

I am not going to directly link to the fraudulent sites in this post because I can’t afford to be sued.  But I will link you to a forum where braver souls than I are discussing this scam.

So, if you are still set on getting some training to help you land that first pharma job, how can you stay safe and avoid getting scammed?

1.  Avoid online courses if possible. If you must go this route, ensure that the course is offered by a legitimate organization, like an accredited university or a government agency. In-class training is almost always more valuable, especially if it includes a co-op or other hands-on element.
2. Do your research! Use the power of the internet to search for discussions about the program you’re considering. Be extremely skeptical when reading positive reviews and pay close attention to any negative comments being made.
3. Ask the experts. Try to speak to people who are actually working in the industry to find out what training programs they recommend. Check out the websites for professional association, and see which programs they recommend.  For clinical research, you should check out the Association for Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Of course, clinical research is not the only area where scam courses and certifications exist. I am also aware of some shady sites related to Medical Science Liaison training. Basically, any career path that is in high demand by job seekers provides an opportunity for con artists to take your hard-earned cash.  Be careful out there.

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