What is trying your patience these days? Changing guidelines? Higher standards for methodological rigor? More frequent submissions? The bar for regulatory writing keeps rising with no end in sight. Add training requirements, unforeseen developments, and conflicting deadlines, and you will likely find your writing team struggling to keep up. Clearly, you need to find a way to buffer fluctuating regulatory workloads, not only to meet the requirements of your business, but to keep your regulatory writing team from burning out, and your budget from burning up prematurely.
So what is the best solution to these challenges, giving you both the flexibility and scalability that your business is demanding from your team? It depends on your situation.
In this paper we will share three possible approaches that can be successful, and share the pro’s and con’s of each approach. With decades of experience working with many of the top medical device and pharmaceutical companies, we can share some of the lessons we have learned.
The three approaches we will address are:
While there may be other solutions, e.g. creating more efficient processes, implementing better tools, pushing back on requirements/pushing out deadlines, etc., we will leave those for future posts, and instead focus on the human element here.
Do have a relatively constant need for more capacity? Or does your writing require very specialized skills that don’t exist in great numbers outside of your organization? If so, expanding your team with a new full-time member may be a good option for you.
Advantages: A new team member not only ensures a permanent increase in capacity but also adds consistency and reliability. Once the new member has been trained to your procedures and standards, interactions and integration within the team will be seamless and smooth. The new team member may also be trained to support different aspects of your regulatory workload. With a longer-term commitment, training on diverse subjects is an worthwhile investment in your team. And, of course, on-site presence can foster clear and consistent communication.
Downsides: Hiring a new member will not be cost-effective if the workload for your team fluctuates substantially. With full-time salary plus benefits, you are paying for the capacity, whether it is needed or not. And if your workload fluctuates, the addition of a single member may not be enough to buffer peak demand, leaving you still searching for additional solutions. Lastly, hiring a new person takes time and money up-front. If you need very specific skillsets, it may take time to identify a good match on the job market, or it may not be possible, such that you will need to invest in extensive training before your new team member becomes productive.
Bottom-Line/Best When: You have a clear scope of work and understanding of skills needed for the next year or two. This is especially useful if the required skills can not be found through outsourcers or contractors, i.e. very specialized training is needed.
If you are not sure that your writing needs justify a new permanent hire, outsourcing to a single contract writer may be a viable solution. This may involve a full-time remote position, a full-time in-house position, or part-time options.
Advantages: This strategy adds manpower to your team without the cost and major commitment associated with a permanent hire. Contracting a writer adds consistency and a personal interface, whether in-house or remote. Once you and your team are familiar with the writer, you will know what to expect. A long-term contract may give you enough confidence to train the contractor as well, knowing they will be around long enough to pay back that investment.
Downsides: Considering the temporary nature of individual contracts, you may not want to invest much in training. Even a long-term contract can end early for various reasons – contractor gets a better offer, etc. And if you are not willing to train, this strategy requires that you know all of the skills you are looking for, and availability of individuals with the corresponding expertise on the market. If the skillset is high in demand, you may experience delays in finding a suitable match. Or if your workload fluctuates, the addition of a single writer for 40 hours a week may not be sufficient during times of peak demand, and at other times you may have difficulty keeping them occupied. (In some ways, a single contractor can look a lot like a hire, as they may not be willing to adjust their hours to your requirements.) An important drawback of outsourcing to a single contract writer is that you will have to start over when the contracts ends and the writer moves on to a different job.
Bottom-Line/Best When:You have a clear understanding of skills needed, and know your workload will fluctuate, but within a certain band. Also best if you know the skills are fairly available in the contract market so the writer can be quickly replaced when needed.
If you are faced with significant, unpredictable fluctuations in workload, wide-ranging skill set requirements, multiple types of deliverables (including documents that require extensive expertise or specific skill sets) neither of the options above will provide you with the flexiblity and scalability that you are looking for. In this case, outsourcing to an established team of writers may be your only option.
Advantages: An established team of experienced writers, with broad and varied expertise, can support your writing needs on multiple levels and with diverse projects. Outsourcing deliverables to a team on a per project basis means that you only need to pay for work completed. There won’t be any need to involve your HR department–the contract will concern the deliverable only. And the task of scaling capacity is now the provider’s responsibility, not yours. The cost may be higher than for a single writer on contract, but there is no learning curve or training requirement: You only need to specify the requirements of the deliverable and define the specifics in a statement of work. If there are any delays with the project, you are not paying staff or contract writers for idle time. And if you have chosen the right company, one with a consistent track record and a wide breadth of experience and skill sets, you will be able to rely on them no matter what type of work is required.
Downsides:As noted above, working with a company may be more expensive (at least on a per-hour basis) than working directly with a single contractor or hiring a new employee, but overall project costs may be comparable considering the flexibility of the team (you only pay for hours worked). Also, while you will not personally interface which each member of the writing team, you will interact with a consistent point of contact – usually the project manager – who can handle any personnel and quality issues for you. And there is a risk of “putting all of your eggs in one basket,” so that if the company fails to perform, they can cause significant issues. For this reason, it is important to thoroughly vet any partner you may consider working with in this capacity, to make sure they can truly handle the scale and scope of the work.
Bottom-Line/Best When: You don’t have a clear understanding of the scope and skills that will be required in the next year or two, or the skills may be hard to find in the marketplace. This option is especially useful if you would like someone else to manage the risks of changes in your work, i.e. the provider can scale-up or down quickly and can provide a range of experience.
Criterion Edge was founded to provide scalability and flexibility to clients, in addition to bringing best-in-class processes and expertise in all aspects of regulatory writing. As regulatory writing experts supporting multiple clients across different industries with diverse projects, we have time-tested processes to quickly ramp up writing and support capacity. Our team has over 40 years of experience at major medical device and pharmaceutical companies, and we work with many of the top 10 industry leaders in the world.
If you would like to learn more about how we make our clients successful, you can watch our video or download a quick description of our services. You can also contact us here, at email@example.com, or at 805-202-5520.
We had a large turnout at our webinar on April 29, 2020, “How to Assess Your CER for MDR Readiness, Part 1 : State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review.” We ended with many unanswered questions. To answer these and more questions, President Laurie Mitchell is coming back to host a Question & Answer session LIVE.
Jun 4, 2020 11:00 AM in Pacific Time (US and Canada)