by Suzanne Canada, PhD; edited by Susan E Caldwell, PhD
Posted on 16 December 2010 to Suzanne Canada’s blog, TanagerPerspectivesBlog, and published on 3 January 2011 in Susan Caldwell’s medical writing newsletter, the Biotech Ink Insider, Vol 4 No 1.
After several years as an in-house writer, I have launched my freelance medical writing career. In addition to having skill at crafting high-quality, accurate documents, …and being just delightful to work with…, one way I’ve learned I can demonstrate value to my clients is by working efficiently.
When I begin working for a new client, I’m usually anxious to get to work. But some of the non-writers I’ve reported to don’t understand what a writer needs to start working. In fact, sometimes the lack of the “write” resources causes delays in getting the work done on time, or it can hamper the writer’s ability to produce an optimal work product. On the flip side, most of us know that having the appropriate tools can enhance the work product and project timeline. So, here’s my list of some of the important resources that writers need in order to be productive:
1. A good writing space. It makes no sense to hire a professional writer, and then require them to sit for eight hours a day in a hall next to the elevators, or in a cube next to the kitchen. The medical writer’s work is very detail oriented, with a need to focus on data-heavy material; so, the writer needs a quiet place to do uninterrupted work.
2. A good computer set-up. Since the writer’s primary job is writing, it’s helpful to have a large computer screen (not the 15-inch diagonal that was in storage from 5 years ago) and a desk that won’t put you in the hospital. Up-to-date software that is compatible with the rest of the client’s staff is a necessity, of course. At a minimum, this usually includes Microsoft Office, Adobe Acrobat (full version, not the reader), and Outlook (or other communication software).
3. Training on company procedures and processes. Although experienced and probably current on their computer skills, writers should be trained on relevant SOPs, templates, style guides, or procedures. Companies must train contractors as well as employees on these processes, and can be “dinged” in an audit if they don’t. Many client companies, though, don’t think about this responsibility, so it’s a good idea to prompt them about writer training. Most will appreciate the reminder.
4. Access to information. Most clinical, regulatory, and research staff are unaware of the detail and types of information that comprise reports, so it’s best to give the writer access to the tables, listings, figures, and other relevant data at the start of the writing process. At one company, it took me two weeks to get access to the location where all the documents were kept, because of justifications required by IT. Sometimes clients don’t realize that this lack of access to critical documents can hamstring the document development project and cause the writing team to miss deadlines.
5. Access to reviewers and other key people. The writer needs to know the people on the project team, including their roles in the organization. This may mean giving the writer an org chart, inviting her or him to key meetings, or providing a list of the people on the team so introductions can happen. Certainly, it means the writer should be included in writing project team meetings and emails that pertain to the document’s content development. Optimally, when the writer comes on board, someone in house should facilitate the introductions, so that everybody knows who the writer is.
The medical writer’s role is at a critical point in product development that can profoundly speed up or slow down the product launch date. Bringing in a contract medical writer can get document projects off the ground that would otherwise languish for months or years, saving companies time and, in the end, a great deal of money. It makes sense for those who hire the writers to ensure up front that the writer’s working environment has the resources needed to produce a high-quality, timely work product. Making sure that the right environment is available for the writer is time and effort well invested.
About the Author
Suzanne Canada, PhD, is a freelance medical writer with more than 10 years of experience in the biotechnology industry; she also has AMWA editing and writing core certification. Suzanne specializes in developing documents that support BLA, IND, and NDA submissions to the United States FDA. You can find more information about Suzanne on her company website, www.TanagerMW.com.