In the past, time management experts would recommend that you divide up your work into A tasks, B tasks, and C tasks. The concept was to do the A tasks first, then the B tasks, then the C tasks, when you can get to them. If priorities changed, you just changed the order of your As, Bs, and Cs. Doing all aspects of a job seemed possible then, if you just followed some basic time management rules.

No matter the job, everyone ended up with a lot more work. And although there have been real gains in productivity since then, the days of A, B, and C tasks are over. Overwhelmed is the new normal.

Take an active approach. Design a new, do-able job for yourself. Here’s when to do it:

• When you start a new job,you have a fresh perspective on what has to be done and you can see the low-value work more easily. Take a look at everything on your plate. Propose three-month goals to your manager, getting rid of as many useless tasks as you can.
• When more responsibility is added to what you already do, you have an opportunity to restructure your work and present your plan. Offer choices to your manager: “Should I lead this task considering it will take approximately 20% of my time? Or, should I…?”
• When you have done an amazing job of something and everyone is celebrating, it’s a great time to ask for something. Ask for help reducing your low-value work from your company’s productivity unit or IT gurus.

   
And here’s how to do it:

• Vote it off the island. Another approach is to ask your clients & colleagues if you cannot do something. The idea is simply to stop doing something that isn’t important, but to check first so that it doesn’t get you into trouble.
• Automate it. If it’s low value, it’s easy to automate. Find any IT solutions around that can be of help. Whether you are talking about project tracking, content digitization, QC or publishing, there are simpler cloud based applications that you could use.
• Write your own rules. Limit what you are going to do and then make sure people know your rules. It will save hours of time.

It’s your job, after all. Make it work for you. And stop doing that low-value work.

Why Best Practices are needed for Writing for Reuse?

Because without reuse, you cannot deliver content at scale or achieve efficiency
And if you products sell globally, you also start with best practices for writing global-ready content.
Here are four best practices that we recommend for any content standardization effort, along with the reasons why your audience and will appreciate your efforts.

1. Standardize terminology

Customers can understand your content quicker and better when you don’t keep switching words on them.
Reuse : Standardized terminology enables small chunks of content to fit together and flow seamlessly. It reduces ambiguity.

Global : Translation costs are per word. Using consistent words lowers cost.

2. Use consistent grammar and style

Customers can resonate with who you are as a company when all content is written by “the company” and not dozens of individual writers.
Reuse : Consistent grammar and style enable small chunks of content to fit together and flow seamlessly.

Global : Sentences must be grammatically correct for successful translation. Consistent grammar and style allow translators to work faster and produce more accurate results.

3. Say the same thing, the same way, everywhere you say it

Customers develop trust in your company when your content is consistent.
Reuse : Eliminate duplicated content and duplicated effort by adopting a reuse mindset. Write it once, review it once, approve it once, update it once, and then use it everywhere it is needed.

Global : Minimal amount of translation and maximum amount of exact or fuzzy matches significantly reduces translation cost. And, global customers also benefit from eliminating ambiguity from your content.

4. Reduce sentence length and complexity

Your Audience (whether HA, Regulators, HCPs or end consumers) brevity and simplicity. No one ever complained about a short, easy to read sentence.
Reuse : Short, clear sentences help create focused components. You can easily assemble short components into a longer work. Shorter, simple sentences are easier to understand.

Global : Short, clear sentences have more successful translation. They are also easier to understand for non-native speakers.

By following these 4 best practices, you can solve reuse problems and make your translations better, cheaper, and faster. Adapting a Structured content tool, can help automate these and gain significant efficiencies.

According to Gartner, Innovation leaders lack a defined strategy to scale automation with tactical and strategic goals. They must deliver end-to-end automation beyond

RPA by combining complementary technologies to augment business processes.

Gartner calls this “Hyperautomation”.

How can enterprises define a winning automation strategy, combine Digital Ops tools, and augment business processes for agility and scale?

Gartner analysts Saikat Ray, Cathy Tornbohm, Marc Kerremans, and Derek Miers have authored a paper that examines the key challenges of hyper automation and how to optimize for success.

Track Changes and similar group-editing programs have revolutionized the editing process, and we should be thankful for those advances. But these programs don’t begin to address the dark side of group edits: rounds and rounds of disagreement, competing levels of expertise and authority, and excessive nitpicking that leave project managers ready to approve anything so long as it successfully moves the document out of review.

Get Everyone on the Same Page

Confusion and inefficiencies are inevitable during the review process unless all editors understand the point of the communication. Talk to whoever conceived the idea and write down their point. Not just their topic, but their point what that person is arguing for, proposing, or contending. Once that point is clear, share it with all review participants so they know and support the editorial objective with their edits.

If the topic is detailed or specialized, check in early with a subject matter expert on the document’s overall point and approach before asking them to review a completed manuscript. This preemptive approach may save you a lot of trouble down the road if someone disagrees with the principles, not just the paragraphs.

Limit Participants

Simplifying an editorial review starts with limiting the number of people working directly on the document, because smaller groups act more efficiently than larger ones. Too many voices can also slow down or stall a project, even when they agree.

Try to pick review participants with efficiency in mind, and remember that effective review is about editing, not brainstorming which means focusing on corrections, not reactions. In a brainstorm, two heads are better than one. But in a document review process, the fewer heads, the better.

Try to Keep Reviewers in Their Lanes

Often, reviewers will see themselves as general copyeditors in addition to subject matter experts. Of course, take their suggestions related to subject matter accuracy, but recognize that the writer and the final approver make all final decisions pertaining to words, style, voice, and editorial structure.

To keep reviewers in their lanes as much as possible, try to show them only the sections related to their expert review, not the entire document. If, for some reason, they need to re-review material, keep showing them only the relevant sections containing that content.

Form Committees

A group review train stalls when “everybody is reviewing everything,” so keep trying to create smaller committees to either work on specific sections or to provide primary edits that will be reviewed later by others higher up in the food chain. Committees can be grouped by subject matter expertise or by hierarchy for example, the first group is directors, and the second group is vice presidents. It’s worth repeating: the smaller the review group is, the more efficiently it will operate.

Where I work, a senior executive invited to a group edit will often say to her team, “everyone, please work on this and share with me only the final draft.” This process approach is an effective way to avoid micro-management and excessive commentary, so feel free to suggest that process yourself if your committee includes both senior executives and mid-level managers.

Leverage Technology

Given that some very intuitive and easy-to-integrate Writing (either Structured or Automated) tools do exist out in the external market, with the precise purpose of assisting in improving writing and editing efficiency, it seems surprising that companies do not make more use of them – especially as the time and cost savings associated with digital solutions are shown to exceed 60 per cent when compared with processes that rely on manual writing alone.

Several research articles and surveys point that the non-core activities like QC, Publishing, Submission-readiness costs companies 25 to 50% of their authoring time of the total author time based on the type of documents. You can do the math based on how many documents you are authoring/modifying per month to see the budget spent (and unfortunately in most companies this is not tracked well to see the gravity of this challenge). You can stop or minimize this $$ drain and free up time for your resources.

Technology and tools available that can help Writing teams minimize this non-core time and automate publishing, validation and QC. In addition to all these, add tracking and other workflow based options on top of these to keep writing teams more organized and focused.

Simplifying a complicated process along with a Tool/Software elevates not only the quality of the work but also team morale and enthusiasm. Conversely, the more red, the more dread, so keep talking with your colleagues and supervisors about ways to make your review processes more efficient and productive.

CMC Authoring is an art of science. Here comes the conflict of automation which is seen as “inhuman”. But as requirements are multiplying every day, how can companies manage the load without increasing resources or resorting to outsourcing or offshoring?

All CMC teams want to spend time on “science” or “innovative projects” and not seen as a ‘cost center’. With these objectives and workload increasing, a case for technology enablement and automation is strong. So, what is holding companies back from investing in Authoring, Publishing & QC automation?

Below are three of the most common perceived barriers to technology-enabled CMC automation, and how and why they should be addressed at the earliest.

1. A lack of “Writing” friendly enterprise solutions

Look at most other industries, especially those that are highly regulated, and use of IT systems tends to be highly evolved. That’s because organizations have long realized the inefficiency (in cost, time and resources) of using people to manually input data into core business systems, and then physically re-enter the information into documents and repeat the duplication in life-cycle or other country specific documents.

In pharma, by contrast, “EDMS” and “Word” are the only and dominant tools provided to Authors. EDMS (whether on premise or cloud) may provide some help like versions, tracking, collaboration, but doesn’t address the bulk of manual heavy lifting that needs in Authoring. Same with WORD in spite of adding some macros.

In some cases, the issue is that CMC departments lack access to relevant technology expertise and knowledge, so they don’t have a picture of what’s available or what’s possible – including the scope for sourcing solutions and optimized business processes via cloud-based platforms and relationships with technology vendors. Meanwhile, larger companies which do have sufficient internal resources often believe that they need to build any tools themselves, something they may never get round to – especially if they haven’t tied down a proper business case & ROI.

Given that some very intuitive and easy-to-integrate Authoring (either Structured or Automated) tools do exist out in the external market, with the precise purpose of assisting in improving writing efficiency, it seems surprising that sponsors do not make more use of them – especially as the time and cost savings associated with digital solutions are shown to exceed 60 per cent when compared with processes that rely on manual writing alone.

2. Cost

For reasons mentioned earlier, Authoring does not tend to attract big budgets. This means that any investment in Writing management IT needs to be tightly targeted, and seen to deliver improved results with greater efficiency. If companies choose not to invest in transforming Writing activity, they risk spending more than they need to, and consuming too much time of busy people who have other more critical tasks to be getting on with.

While large companies, may question the cost/benefit trade-off of creating new automation aids, their internal development is not the only option. Taking advantage of a pre- existing pre-tested tool that’s ready to go today and accessible on demand via a software-as-a-service delivery model, changes the economics considerably – especially if there is no associated support burden, because the vendor takes care of everything.

3. How about Non-core Authoring tasks?

Several research articles and surveys point that the non-core activities like QC, Publishing, Submission-readiness costs companies 25 to 50% of their authoring time of the total time based on the type of documents. You can do the math based on how many CMC documents you are authoring/modifying per month to see the budget spent (and unfortunately in most companies this is not tracked well to see the gravity of this challenge). You can stop or minimize this $$ drain and free up time for your resources.
Technology and tools available that can help CMC Authors minimize this non-core time and automate publishing, validation and QC. In addition to all these, add tracking and other workflow based options on top of these to keep CMC teams more organized and focused.

Why wait?
Looking for discrete tools which are very easy to adopt and use, and which alleviate a substantial manual administrative burden– are a good way for companies to test the potential of CMC automation and amass some experience.

Embracing greater automation is going to be essential as writing/reporting/publishing requirements continue to multiply and grow, placing an ever greater strain on resources. Automation offers a way to cope with rising demand, and to simplify demanding routine tasks, as companies expand their product mix and market coverage, while maintaining regulatory compliance.

Yet, to take full advantage of the opportunities, companies need to overcome their historical barriers to technology adoption – and there is no time like the present with several lessons learned by in this pre and post Covid era.