Author: Ashley Self
I bet when you became a medical writer, you didn’t imagine most of your time would be spent on managerial tasks that don’t involve writing at all. According to one prominent medical writing consultant, most medical writers spend 60% of their time on writing and 40% on project management. As you have likely discovered, the skills required of today’s medical writers go beyond subject matter and regulatory expertise. Given the size and scope of most medical writing projects, this is no surprise. If you find yourself overwhelmed by the project management oversight needed for large projects and overlapping projects involving multiple writers, you’re not alone.
A 2017 Project Management Institute study found most project management initiatives fail for a handful of reasons: 37% fail due to a lack of clearly defined and/or achievable milestones and objectives to measure progress, 19% break down because of poor communication and, similarly, 18% fail due to lack of communication by senior management. While no project can be made absolutely foolproof, seasoned medical writers have learned to rely on advance planning and adherence to certain basic guidelines to ensure their projects run smoothly.
For your next project, once the project liaison has met with stakeholders to nail down the scope and budget, use these six key tactics to ensure your next medical writing job runs smoothly and meets the necessary requirements.
Tempted to throw your project calendar out the window after a series of missed deadlines? Consider using a comprehensive project scope and calendar matrix. The matrix should be the product of a detailed meeting with the project stakeholders and leads on both sides, and highlight who is in charge of what deliverables, who is responsible for signing off on that material, and clear deadlines for each. Each section of the matrix should call out not just final due dates from the writers, but also how long the principals have to review submitted sections and how long it should take to make final revisions.
It takes quite a bit of work just to build a matrix that will cover the extensive information required for most medical writing projects, and, as you know, things come up during any project that require flexibility and reworking of the matrix: new data is released and has to be worked in, other data is held up in final review, a principal plans a vacation when they were scheduled to review their section, etc. Therefore, in addition to the matrix, you should also have contingency plans in place for when things go awry.
As a lead writer on a large project, you likely manage multiple writers and also interface with a principal contact on the stakeholder side, or, in some cases, the stakeholders themselves. Having the ability to communicate effectively with both is a valued skill.
Communications with stakeholder representatives should be kept to a minimum. Unless there is an urgent issue that will substantially affect sensitive project timelines, batch any news or concerns into periodic updates. Sensitive issues should be handled over the phone.
Within your own team, clear, detailed communication is key for keeping the project running smoothly. Create an internal email group or chat platform for each project so that those writers are privy to all project-related correspondence.
For communications with both stakeholders and internal writing teams, taking the time to generate a file of email templates prepared for various scenarios will streamline your communication process and ensure key questions/points aren’t inadvertently left out in the heat of the moment. Make the email subject lines very clear and don’t be afraid to call out that an RSVP is required urgently. To make the body of the email skimmable, write a short summary of what the email requires and use bullet points and bold text to highlight key points.
Finally, don’t be afraid to pick up the phone. Sometimes a quick call can subvert a lengthy email exchange.
There are two ways to manage changes and updates to large medical regulatory documents: use/update one dedicated document and reconcile changes manually or via the application’s automated tools; or, use a secure, cloud-based application that allows changes from multiple sources in real time. Either way, sufficient time must be spent ensuring all changes were made correctly, and also that the changes did not upset the document’s formatting. When reviewing changes to a section using a tracking feature, be sure and do a final review of the section with all the highlights turned off to make sure the formatting hasn’t shifted, and verify that the sentence structure is in tact.
One of the lead writer’s lesser-known skills is new writer training.Certainly, you don’t have substantial time to sit down with each new writer as they come on board and walk them through basic SOPs. A database of graduated training materials can get new writers up to speed on company processes, style-sheets, use of document templates, and other standard procedures. That leaves more time for you to give new writers valuable feedback and answer specific questions as they are introduced to new projects.
Proofing and fact checking a near 300-page document can be arduous, and, in fact, most lead writers report spending a large percentage of their time on the task. While there’s no real way to speed up a read-through of the entire document, checking the document against a predetermined style sheet can make locating errors in naming conventions, broken formatting, and missed template fields much quicker. Using the “Find” command for red-flagged terms and template <<field>> terms can help you catch many things before you even begin the proofing process. A style sheet can also call out known areas of concern so that writers can review those sections more effectively.
While this process can be time consuming, it reflects well on your company’s reputation to submit documents for stakeholder review with these errors resolved.
The best time to identify holes in your workflow is right after a project is completed. Budget in the time for a sit down (or web conference) with your principal and your writers and download all that went right or wrong with the project. This may seem redundant, but it is a step that will inform the schedules/planning of future projects and also help you build contingencies based on real scenarios while they are still fresh.
Criterion Edge (CE) employs top talent in the regulatory business to deliver high quality medical/regulatory writing and clinical safety services to the pharmaceutical and medical device industries. Members of the CE team enjoy support from our project managers, support staff, and ongoing training programs to keep them up-to-date on the latest regulatory guidelines. Interested in being a part of our team? Check out our current openings.
Regulatory writing and publishing is a critical component in regulatory affairs, and manufacturers must comply with varying regional regulations and increasingly rigorous disclosure and evaluation standards. Companies therefore need good strategies to keep the budget for medical writing in check, while meeting escalating demands, evolving regulations, and unrelenting timelines.
Are you are asking yourself, “How can I get the most out of my project budget?” We can help you answer this. (more…)
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