Getting Started in the Regulatory Writing Field

Cartoon by Mark Anderson, Andertoons (http://www.andertoons.com/)

A technical writer in the Greater Boston area sent me the following email.

Hi,

I am interested in a career move, to the field of regulatory writing for medical devices. I feel that my software development experience, attention to detail and technical skills would transition well to this endeavor.

I am looking for suggestions for training or certificates that would prepare me for this field. What type of training do people look for when they are hiring for regulatory writing? I appreciate any suggestions you can provide.

Signed, Career Move

I’ve been working in the regulatory writing field since 1992 and TRA360 has had a regulatory writing practice since 1997 so I had some ideas to share. Here they are:

Dear Career Move,

Regarding your career move into regulatory writing for medical devices, two options come to mind, both of which lead to a certificate: academic coursework and a professional program. On the academic side, I would check into courses and certificate programs at some of the Greater Boston area colleges and universities: Northeastern, Wentworth Institute of Technology, Mass College of Pharmacy, Worcester Polytechnic Institute, UMass Boston, University of Lowell, MassBay Community College, Bunker Hill Community College, and Roxbury Community College come immediately to mind. I would expect that they would have both online and on-ground offerings.

Depending on the time and money you choose to invest, you can look into a more full-fledged program such as the Graduate Biomedical Writing program offered at the University of the Sciences in Philadelphia.

On the professional side, you might consider organizations like Regulatory Affairs Professional Society and Drug Information Association. I just went to the RAPS website and they have an online Regulatory Affairs Certificate: Medical Devices certificate that might be of interest.

Let me know if these resources are of value. If you find any others, please share them with me.

Thanks,
Tim

*****************

Does anyone know of other resources that might be of value to Career Move?

Capturing the Odd Moment of Endless Wins

There was intermittent sunshine and puffed lead looking clouds.

Lotus Development Corporation had already moved into a newer and more spacious Cambridge site.

I was sitting—a comfortable bench at the ground floor—the street level, the entrance area.

I had just come from Harvard, waiting to meet, Linda, who worked upstairs as a Lotus Q/A wrangler. We were going to a Mexican Restaurant, just down the street.

This area—cool and comfortable. I was sitting on a bench reading an old book in English published “Ceylon, 1910”—The Pratitya Samutpada Sutta—on the idea that THE ALL = The Simultaneous Interdependent Origination of All Phenomena—thus THE ALL was existing within and without itself and basically was both connected and not connected to the “Inside” and “Outside” of Actual Being. Waiting was comfortable and relaxed—very few people wandering around.

This guy in a dark suit that was a little bit too big for him, came up into the corner of my eye and said, “Whatcha reading?”

I replied with the book title, expecting the old “Say what?” or some signal of not caring at all, or “I don’t have time from this crap…unimportant anyway.”

But he sat down, saw the book title, and started talking cogently about Buddhism and the Nature of Reality. I recognized him. “You’re Jobs, aren’t you?”

“Steve,” he said.

And we talked for about an hour: The Nature of Reality and how people react to even thinking about it; why people run away from it; zen koans and the nature of hidden laughter within important truths; the nature of “taking the medicine instead of worshipping the prescription,” interactions and simultaneity of Compassion, Wisdom, and Power.

So fast “Steve” became a brother with no blood roots to me. He was a Brother to the Many Minds of Us–The Other Brothers–The Other Sisters. He joined his intelligence to the many, and never kept it for himself. How can I miss him since I and We–the Brothers & Sisters–are still joined at the hip. And I am not alone.

Mass Innovation Nights, ePowerhouse and more!

Last night I had the pleasure of attending the 31st Mass Innovation Night, at the Trade Center 128 in Woburn. It was cool to see a handful of startups and their strategies for growth. I was surprised to see and 0ld friend, Alexander Tsepko of Grafpad doing a professional pitch when only months ago he was at the Venture Cafe testing the water. That in itself is a testament to the great resources in the area being made available to entrepreneurs. Speaking of resources…

Mass Innovation Night
Mass Innovation Night #MIN31

ePowerhouse is a company trying to help entrepreneurs and investors. The accelerator program being created and the network around it will soon evolve into a hub for both investors and entrepreneurs. After all, who likes going to a million different places to do a million different things when trying to start a company? Surely there is an easier and more efficient way. From talent pools, comprehensive event calender,  incubators to capital acceleration programs, EPH will change the landscape for entrepreneurs, and not just locally. But yeah check it out at the link.

Finally, Hubspot has been providing some great resources on social media. I went to an event last week at Hubspot and as usual, learned a lot. Right when my arrogance kicks in and I think I know everything, I talk with some more knowledgeable people and realize some great concepts and ideas. That’s what networking is all about.

 

 

eConnectors in MIT

This past week sure has been a busy one. Nothing like being back in the swing of both school and work. I’m sure It’ll all pay off with that diploma in December though.

Wednesday I had a great time visiting my dream school (MIT) for their eConnectors meetup. This was all part of an initiate by David Zhou whose in the midst of creating Boston’s best entrepreneurship hub dubbed ePowerhouse. It’s still in alpha phase, but in meeting David and hearing about his vision, I’m sure that this site will take off once it goes live. I think the idea of aggregating entrepreneurs, investors, startups, people looking for work and events is wonderful. I know I would use instead of checking numerous calenders each week for events.eConnectors in MIT

The insights from the panel were golden nuggets of wisdom from some very successful businessmen. I got a lot out of the meeting and hopefully can apply some of the knowledge in my own career. I’d highly recommend that anyone in business check out the next meetup in about a month.