Getting Started in the Regulatory Writing Field

Posted on October 19, 2011May 20, 2013 by Valentina Rosa

andertoon lateral move — 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

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

Massachusetts Life Science Center Internship Challenge Summer 2011 Launch Event

Posted on June 17, 2011May 20, 2013 by Valentina Rosa

l to r: Ryan Collins (TRA360) and Ryan Mudawar (MLSC) at the Internship Challenge, Summer 2011 Launch Event — l to r: Ryan Connors (TRA360) and Ryan Mudawar (MLSC)

Yesterday I had the pleasure of attending two important events representing TRA360 with Tim. The first was the Massachusetts Life Science Internship Challenge Summer 2011 Launch Event held at Worcester Polytechnic Institute’s Life Sciences & Bioengineering Center. It was a great event where all of the interns, their sponsors, and the brains behind the MLSC met for networking, learning and sharing of information.

Lieutenant Governor Timothy Murray gave a compelling speech about the benefits of the program, which I can attest to. He also announced the expansion of the program to be year-round, which is wonderful given the opportunities it offers bridging academia with the private sector, especially in these tough economic times. Anyone who’s gone job hunting recently knows the importance of experience in the field and how a lack thereof can be crippling.

I also got some face time with the Dr. Susan Windham-Bannister, President & CEO of the Massachusetts Life Sciences Center. Her dedication to the program is unparallelled. I enjoyed most of the discussions with various industry leaders such as Steve Kelly, CEO of Myomo (an inspiring and innovative company using robotics to help the handicapped regain mobility). Overall, I found the entire program to be worthwhile and exciting, and I valued getting to know some of my fellow interns and I hope to stay in touch with them.

Props to everyone who organized and attended the event.

Kicking Off the MLSC Summer Internship Challenge

Posted on June 16, 2011May 20, 2013 by Valentina Rosa

Ryan Connors, TRA360’s Summer Intern and I attended the Massachusetts Life Sciences Center (MLSC) Internship Challenge Summer 2011 Launch Event. Thanks to the MLSC for inviting us.

The event was hosted at the WPI Life Sciences and Bioengineering Center. The WPI Center is AMAZING! It’s a new, big, and exciting place to be and to work. The WPI Center is aptly located in Gateway Park—it’s a gateway to Boston/Cambridge, Worcester, and Western Massachusetts.

Susan Windham-Bannister and the entire MLSC staff know how to do things right. The venue was beautiful, the speakers were varied and engaging, and the three hours flew past.

Lieutenant Governor Tim Murray with MLSC interns (left to right: Sadie McCarthy, Kelsey Scheidemantel, & Max Notis)

Lieutenant Governor Tim Murray talked about growing up in Worcester and becoming the mayor before moving to the State House. His announcement that the Internship Challenge Program would be expanded to a year-round program was received by huge rounds of applause from both interns and sponsors.

Kevin O’Sullivan, President and CEO of Massachusetts Biomedical Initiatives, got everyone jazzed up by his palpable passion and contagious energy. When speaking directly to the interns he said: “You’ve got ‘it’ (you know what I mean!)” and “I have one request: Stay here! Stay here in Massachusetts after you graduate.”

The armchair conversation with Susan, Joshua Boger, former CEO of Vertex Pharmaceuticals, and Lydia Villa-Komaroff, Chief Scientific Officer for Ctyonome/ST. There were so many jewels of insights offered by these three giants in our industry. Among the best were Lydia’s comments on the importance of curiosity and persistence (she spoke with 244 (!) prospects to get funding for Ctyonome and Josh’s phrase that people in our industry need to possess a “borderline psychotic confidence.”

Norm Garceau, Chief Scientific Officer of Blue Sky Biotech, spoke about leaving the comfort of Pfizer to join a start-up and Caitlin Pond, a 2010 Intern and Research Associate at Blue Sky Biotech, warmed our hearts with her honesty, commitment, and incredible energy.

Steve Kelly, CEO of Myomo, got the crowd laughing with his slideshow and great sense of humor. He also demonstrated how his company is making robotic products that are fundamentally changing people’s lives.

The Internship Challenge has grown by leaps and bounds since it was started in 2009. Take a look at these exceptional numbers:

Intern/Sponsor Data	Summer 2009	Summer 2010	Summer 2011
Student applications	508	899	1,323
Interns placed	104	170	216
Registered sponsors	77	140	178
Actual sponsors	59	94	123

We met a lot of people and had a great time! We’re thrilled to participate as an MLSC Internship Sponsor again this year. Ryan’s doing a superb job for TRA360. He’s just finishing his fourth week and he’s already a fixture.

Pfizer Launches $100M Center for Therapeutic Innovation

Posted on June 9, 2011June 4, 2015 by Valentina Rosa

Pfizer has launched a 100 million dollar innovation center in Boston today (http://bit.ly/msVCqn). This is the third such center in the US, followed by ones in New York and San Francisco. The five-year plan to establish a new Center for Therapeutic Innovation, teaming three investigators from such institutions as Beth Israel Deaconess, Boston University, Harvard University, Tufts Medical Center, and Partners HealthCare to select the most promising projects.

While it’s great that Pfizer is making such a massive investment in the local R&D community, this comes from a company that has been slashing its R&D budget for years. Unless they are able to identify committed, innovative, and talented teams of people, this investment won’t reap the benefits that Pfizer sorely needs. What chances do you give to this Innovation Center for success?

Read the Pfizer press release.