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May 8, 2009 | Vol. 2 No. 13 Published by Biotech Ink, LLC | |
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The Medical Writer as Project Manager
by Mitch Gordon |
As a medical writer, you may be great at turning technical talk into well-organized, well-explained written pieces. You may have an amenable personality, a strong work ethic, thoroughness, and an eye for detail. But is this enough? Maybe not, especially in writing clinical and regulatory documentation, when you rely on a number of people from different disciplines. The deadlines may be rigid and very challenging, too. You need to wear another hat--that of project manager.
 This was the subject of an informative and very useful talk given by Anna Hindle at the AMWA Regional Conference at Asilomar last month. Anna is the Associate Director of Medical Writing at Biogen-Idec in San Diego. She manages a large number of clinical and regulatory writing projects, overseeing both staff medical writers and freelancers. Anna doesn't have the time to micromanage all of her department's many writing projects. Instead, she relies on her writers to take a large chunk of the responsibility for keeping their own projects on track. Anna sees this as a model for successfully managing the highly complex and very important medical writing function in regulated life-sciences companies.
As a freelance writer, you may not see yourself in the project manager role. You may just want to sit quietly at your desk, massaging sentences and making the occasional phone call for clarification of an issue. While this works well enough for some kinds of projects-journal articles, for example-regulatory/clinical writing requires an extra measure of control over deliverables and deadlines. Anna likens the project manager role to that of a basketball or football coach: they call out encouragement and admonish from the sidelines, and they can change strategy at a moment's notice to adapt to changing conditions. Thus, the project manager, like the sports coach, is the hub, the central figure who holds all aspects of the project together.
To be effective in a medical writing project management role, you need to learn the players and processes--in other words, get to know the relevant document development processes and project team members. You should begin a project knowing who the team is, and who the approvers and reviewers are.
What should you do to be effective in managing your medical writing project?
1. Meet the people on the team in person, or at least call each of them. You should also research the team members by talking with the medical writing or clinical ops manager you're reporting to.
2. Find out what project management style and procedures have worked in the past, and what has put projects on the rocks.
3. Find out who you're going to have to keep on a short leash when it comes to getting first-draft document pieces or their reviews of your drafts.
4. Learn about the client's existing processes and obtain their document template, style guide, SOPs, background documents (e.g., an investigator brochure or clinical study protocol), and samples of deliverables. Acquiring these documents serves two purposes:
- It helps you integrate into the client's way of doing things.
- It helps you estimate the project cost for bidding. You may be in the fortunate circumstance of billing on a time-and-materials basis, but if you have to provide a fixed-price bid--and this is becoming more common--you should find out everything you can up front, before you submit a bid.
5. Develop a timeline. Figure out each task that will be required, who will do it, how long it will take, and what other tasks must be completed before starting it. Then create a project map in a project planning software package, such as Microsoft Project. You can generate reports and charts listing the tasks from the project map file.
6. Hold a kickoff meeting. Gather the team members in a conference room and explain what is going to happen in the project. Discuss the following items:
- Timeline - Present and discuss the draft timeline you've created and get consensus.
- Responsibilities - Spell out the responsibilities of each person on the team.
- Milestones - Determine what steps will be taken when milestones are missed; get agreement on this, so that if it happens, the offender won't be surprised by the consequences.
- Issues and Problems - Voice your concerns about the project, and get the team to voice theirs, too.
- Recap everything that was discussed and agreed to, and summarize the meeting's discussion in an email to the team.
7. Manage each task and the entire project as the project proceeds. Keep the team and your management contact informed of how well the project is keeping to the schedule, and which tasks, if any, are off track. There will inevitably be project plan changes and unexpected holdups; you'll need to respond to those with a revised project plan and often some quick thinking.
8. Guide the project team members. During the project, you'll need to practice your sheepdog skills on the team members who forget about their deadlines, don't see the importance of their deadlines, or don't concentrate on the pieces of the work that they owe you.
9. Review the statusof the project, and report the results to your management contact. They should be kept informed what's finished (or isn't), and of changes to scheduled start and end dates, estimates of expenditures vs. budget, and resource (especially personnel) requirements. Watch for signs of trouble with the project's schedule or budget, and make your concerns known early.
10. Thank everyone and celebrate when the project is done! Go out for a beer together, or get management to pay for pizzas. It doesn't have to be something big. People just need to hear those magic words, "thank you."
The bottom line is this: as the medical writer and project manager, you don't get to be a wallflower. You are the glue that holds the project together, because all of the pieces involve writing or reviewing, and that's your specialty. By wearing the project management hat--and it may fit better than you think--you enhance the chance of your project's success, and make yourself valuable to the client. And successful projects with satisfied clients are what make a successful freelancing business.
About the Author
Mitch Gordon has been a professional technical writer for 16 years, and is now a freelance medical writer. He is working on his Masters degree in Regulatory Affairs, to be completed in early 2010. His specialties are regulatory and clinical documentation, medical device and diagnostics manuals, training materials, journal articles, slide shows, and posters.
Mitch Gordon
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Personal Financial Health in a Fragile Economy: Tips for Medical Writers
by Susan A Veals, PhD, RN |
It's no secret that the US economy is mired in what is being called "The Great Recession". The national unemployment rate was 8.9% in April 2009, compared with 5.0% the previous April, according to the Bureau of Labor Statistics. There is still work available for medical writers in the relatively recession-resistant healthcare sector. However, the job tracking sites www.indeed.com and www.simplyhired.com report that 10% to 15% fewer company and 82% fewer freelance medical writer jobs were advertised on web sites in April 2009 compared with 2008.  The fragile economy means that now, more than ever, you need to have your personal financial house in order. To help you to review your own situation, I've compiled a list of 9 common recommendations that popular financial advisors make. Disclaimer: This list is not exhaustive. I am not a financial advisor, and I can't recommend any particular course of action for you, nor can I officially endorse the sites and authors mentioned below. See a Certified Financial Planner to get expert advice.
1. Create an emergency cash fund. This is particularly important if you're self-employed and have a variable income. Financial advisors generally recommend keeping at least 6 months of living expenses in an account you can access without penalty, such as a money market deposit or savings account. Make sure the account is insured by the FDIC and earns interest (accounts are averaging just 1.3%, according to www.bankrate.com). Remember, this fund is only for true emergencies.
2. Aim to be debt-free, starting with credit card debt. One caveat: financial adviser and author Suze Orman now recommends making an emergency cash fund your top priority, even if it means paying the minimum on your credit card debt for a time (www.suzeorman.com). Of course, you should continue to make regular payments on all debts. It is worth calling your credit card company to ask for a reduction in the interest rate. Also, investigate how the current record-low interest rates on mortgages can benefit you (www.bankrate.com reports that average rates are under 5%).
3. Keep (or start) saving for retirement. Yes, even in this economy. You do want to retire someday, don't you? Social Security isn't likely to cover your living expenses. You get a big break on taxes when you put money into a retirement account, though you'll pay a stiff penalty if you take money out before age 59 ˝. Examples of retirement accounts include 401(k) plans through your company, and SEP-IRA and solo 401(k) plans if you're self-employed. You can open a Roth or traditional IRA as an individual investor. Pay attention to eligibility and limits on how much you can invest each year. Most of us will save more reliably with dollar cost averaging (investing a certain amount each month; do so rigorously) than with lump sum investing (investing a larger amount once a year), though there is controversy among financial advisors about which earns more in the long run. Decide on your goals (aggressive/risky vs. conservative/safe investments) for your portfolio. You'll want to periodically rebalance your portfolio (i.e. adjust the blend of risk and safety). Ask about diversified plans and those that rebalance automatically as you get nearer to retirement.
4. Make sure you have health insurance. All it takes is one critical illness to wipe out your emergency cash fund. Company-employed medical writers can often take advantage of low-cost group health insurance through work. If you leave your job, COBRA requires your employer to offer you the option of continued group-rate coverage for a time, usually 18 months. Under laws enacted in February 2009, you may be eligible for continued coverage at markedly lower rates if you are or were "involuntarily terminated" between September 1, 2008 and December 31, 2009 (see www.recovery.com). Self-employed writers have to find their own health insurance. The choices are myriad and vary by geographic region, so check with self-employed people in your area. Members of the American Medical Writers Association (www.amwa.org) can look up Health Insurance in the Members Only section for other suggestions for health insurance for the self-employed.
Note: If you're a contract writer in California and need health insurance, consider becoming an LLC or incorporating with at least one other person as a member (for LLCs) or employee (for incorporated companies). Why? Because the law requires health insurance companies in California to offer group health insurance rates and benefits to companies with two or more members/employees.
5. Pay your taxes. This is nearly automatic if you're employed by a company, but do adjust your withholding allowance so you won't owe taxes. If you're self-employed, automatically stow at least 30% of your earnings in an FDIC-insured, interest-paying account to cover Social Security and regular income tax, keep informed about state and federal tax requirements, and file your tax returns every year.
6. Reduce unnecessary expenses. Do you buy a coffee on your way to work? What about impulse buys at the grocery store? Do you eat out often? You can save a significant amount of money every month when you avoid these and other seemingly minor expenditures. David Bach, author of books like "Start Late, Finish Rich" (Broadway Books, 2006, ISBN 978-0-7679-1947-0) calls this the "latté factor". Be disciplined (but don't expect perfection).
7. Live within your means. With the exception of essentials, think very hard before buying anything expensive, and think even harder before buying anything on credit. This is not the time to be buying a new bedroom set or vacation, unless you can pay for it with cash.
8. Protect your family's future. No one likes to talk about it, but you need to hire a lawyer who specializes in estate planning to make a will and possibly a revocable living trust. While you're at it, write an advance directive (also called a living will), and designate someone you trust as your durable power of attorney (DPOA) for health care. Buy life insurance. You want your family to have resources if something happens to you.
9. Educate yourself about financial matters. Read financial advice books and reputable web sites (ask finance-savvy friends and colleagues for their favorites) and listen to financial advisors on television and radio. Be brave about asking questions. Follow through on what you learn.
There are some indications that the economic decline is slowing. For example, stock market indices have been more stable in recent weeks. Last week, the unemployment numbers were better than expected. However, real recovery is not expected until 2010, and is likely to go slowly. Most financial experts didn't anticipate the current economic downturn, so it's hard to trust their predictions about the timing of the recovery. Your best bet is to get yourself organized and join in the new national pastime: frugal living.
Susan A Veals is a Seattle-based freelance medical writer with a PhD and postdoctoral experience in oncology and immunology. She is also a registered nurse with experience in psychiatry, HIV, and oncology. Learning about finance is a hobby for her. You can e-mail Susan at susanveals@gmail.com or go to savmedicalwriting.com.
Copyright 2009. Susan A. Veals. All rights reserved | |
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