Raising the Bar: Essential Competencies for CME Writers with Haifa Kassis and Don Harting

Introduction ges

Are you struggling to break into CME writing or looking to level up your skills

in this specialized field? Maybe you're a hiring manager frustrated by the

challenge of finding qualified writers who understand the unique demands of

continuing education for healthcare professionals. Today on Write Medicine

we're bridging that gap.

Meet the Researchers: Haifa Kassis and Don Harting

I'm sitting down with researchers, Haifa Kassis, and Don Harting, who

developed the first ever competency model for CME writers that identifies

exactly the knowledge, skills, and attitudes that are essential for success in this

field. In the first of its kind study in this area, the researchers reached expert

consensus on 38 essential competencies for CME writers and identified six in-

demand deliverables.

Whether you're new to medical writing and hoping to specialize in CME, an

experienced writer looking to refine your expertise or a company executive

seeking to train and develop your team. This conversation offers practical

insights you won't find anywhere else. Stay tuned as we unpack the four core

competencies that every successful CME writer needs to master and the

surprising findings that emerged from this groundbreaking research. I'm your

host, Alex Howson, and this is Write Medicine.

The Competency Model: Key Findings

Alex: What were some of the things that you were seeing in continuing medical

education that led you to develop this competency model?

Haifa Kassis: Well story goes back to during the pandemic. at the time I was

starting to get emails from lots of people interested in CME writing, becoming a

CME writer. And I talked to Don about that. And we also discussed we're

hearing also from medical education company hiring managers and executives

that they're having a hard time finding good writers. So we kind of felt like

there is a disconnect here between, there's this group of people who are

[00:02:00] really excited about the field, who want to excel in it, who want to

hire them, but there is no bridge between them. New writers often have that they

have to overcome, and there are very few resources out there to help guide

them. So that's where this started and wanted to give a roadmap to new writers,

to entering the field and also establish writers to hone craft and expertise.

Don: There was a kind of a partnering that happened early on. And Haifa and I

met at one of the dinners that we had at the Alliance and, I learned of her

interest in this idea of a competency model.

Expert Consensus and Methodology

Don: And I was, honestly, I was not that familiar with the whole concept of

competency model, but I was very familiar with what I call the Delphi.

I love this research method, cause I had used this research method in graduate

school just a few months before where you assemble this panel of experts and

then you survey them repeatedly to try to get answers to a question of interest

that might be difficult to answer any other way. And we used Haifa's research

question and my research method, to approach this topic. And so far we've been

pretty pleased with the results.

Alex: It's a great combination and obviously we will link to your published

work on this study in the show notes. But in 30 seconds or less, can you

summarize the key findings from the work that you did?

Haifa Kassis: Alright, so in summary, we had a panel of experts help us

identify, knowledge areas, skills and attitudes that the next generation of CME

writers need to excel in their profession. So, among what. We suggested to them

and what they suggested to us. We had a total of 38 knowledge area skills and

attitudes that the panelists voted in risk consensus about. And they include a

wide range of topics and areas, things from, accredit continuing education

[00:04:00] field from healthcare and medicine, from medical education and

communication medical writing and, and communication. So. We also asked the

panelists to help us identify the most in demand deliverables that the next

generation of writers need to be able to develop. Over I think 21 suggestions

and six of those make the consensus. in a sense, we kind of tried to identify and

define the competencies that medical writers who work in see me need in an

effort to help guide training for these writers in the future.

Don: I've had the opportunity of listening to Haifa and now I'd like to boil it

down into one sentence. And that is, so if you wanna get into the CME writing

space and you wanna really focus your efforts in ways that won't be wasted. our

research shows that if you learn four things you won't be wasting your time.

Number one, if you learn basic [00:05:00] instructional design principles in

terms of knowledge area, if you develop your skill on searching the peer

reviewed literature to gather evidence, if you develop an attitude that is

acceptance of the need for ethically valid and compliant content, if you focus on

developing the needs assessment as your key deliverable you will not be

wasting your time. You will meet needs that are in the marketplace today.

Alex: I love that you've been able to distill your work into four succinct skill

areas. That's going to be really helpful to listeners, both on the medical writing

side and on the client side.

Don: If I may just add that we're not saying that we are relaying the expertise

and wisdom that were shared with us from this panel of experts, who,

participated in this survey over a series iterations. And that it was refined and

fine tuned. And we're very grateful to the members of [00:06:00] the panel,

including yourself, and then 19 others who stayed with us those three iterations

to come out with this kind of a distillation of what the key competencies are for

success in the field.

Surprising Insights and Real-World Challenges

Alex: I will definitely get into the methodology in just a little bit here, but

sticking with your findings that you've managed to distill so succinctly, was

there anything surprising to you in terms of knowledge, skills, or attitudes that

the panelists ultimately identified as essential for success? Anything that didn't

resonate? Anything that didn't quite align with how you thought this would pan

out?

Don: There was one that I thought was humorous 'cause I could really relate to

it. One of the attitudes was, that we proposed the idea of being flexible and

being willing to change as project timelines change. And what we saw from one

of the panelists was real pushback on that. And this is how the panelist wrote it.

The attitude that we proposed was recognition of the [00:07:00] need for

flexibility to handle changes in project timelines and needs, and, a vote of four

or higher was to include this in the model and then a vote of, anything less than

four was to exclude it. Panelist six wrote, I think this really depends on how you

run your business. Some flexibility is required in all areas of medical writing

and life, but I think a more important attitude is probably don't let other people's

problems become your emergencies. As a writer, I book up months in advance.

If whoever is doing the project management can't get a faculty member to

deliver on time, and when they finally do deliver, I'm booked with another

project. That is not my problem. I try to educate clients in advance about the

need to keep things on track and explain the reality that if we stray too far from

the timeline, I'm not going to make up for those delays on my side, and I may

not be able to help them complete the project. I think as writers, we need

[00:08:00] to advocate for ourselves. I just found that humorous and relatable

and very memorable.

I think that panelist was just being very realistic. It just really, it resonates with

me because in our business, timelines get messed up all the time and it can be

really annoying about the same time I had a client who. Laid out a whole

timeline that just never materialized anything close to what the client had

projected it to be. And that really messed up my practice because I had a whole

bunch of time that I had nothing to do with I had to fill with other work. And

then later when the faculty came online, I had this, all this other work. Guess

what? I had double booked my personal time and it really threw my personal

schedule into a cocked hat. It's a very relatable perspective

Haifa Kassis: So I think one of the advantages we had that the feedback was

anonymous. So instead of, you know, having a committee of people sitting in a

room and people don't speak up their mind freely because, you know, I

[00:09:00] don't feel comfortable saying contentious things. The fact that we

had them write it down and we shared it anonymously, I think created space for

many of the panelists to speak up about things that on their mind and advocate

for things, otherwise they wouldn't have felt comfortable doing. I didn't expect

to see that much honesty, but, it was refreshing. The other thing I was surprised.

Is how committed the panelists were. I met one of them later and they told me,

well, I was just waiting for your reports between the rounds to dig into them and

see what other people said. Not everybody liked what other people said, but

they were interested in what other people thought and because they had time to

sit and actually read the report, we did our best to make it organized and easy to

read. It's not an easy task to go through so much rationales and [00:10:00]

feedback. But I think it helped people think over assumptions they had

sometimes maybe shift a little bit, but overall they were more aware of why

other people were acting this the way based on what they're thinking. So I think it

opened the window because we also had different three groups of people. We

had writers and teachers and executives. So we had like a wide diverse

perspective topics

Don: One of the things that surprised me was how little attrition there was from

the first round of the surveys to the last round amazing. I think we, we asked 22

people. 21 said yes, and by the end of the third survey, we still had 20 people

with us. And I'll never forget the conversation I had with Haifa at the outset.

I said, Haifa.

Don: We need to incentivize these people. We need to give them, a gift or some

sort of a gift card [00:11:00] or some money or something, or else we're gonna

have so much attrition, we're not gonna have any data at the end. And Haifa

asked me, Don, do we have a profession or don't we, I didn't say it at the time,

but it's, Haifa, don't ask that question because you might not wanna know the

answer. Actually Haifa was right. I was wrong. Everybody stayed with us all the

way to the end. And and it was, I was very surprised. And not to mention, I'm

just thrilled that we had that much support.

Getting back to another one of your questions Alex was about notable surprises.

Anything I was surprised about and I was surprised that, up to date knowledge

in a therapeutic area did not make it into the model. You had to win a vote of

four or greater to be in the model. And up to date medical knowledge in a

therapeutic area got around a 3.6. It was not included in the model. And I

remember the. The debates on this, and what I remember was that the people

who were arguing most in favor of that were the executives, the med-ed

company [00:12:00] executives who were saying things like, this is really how a

medical writer can add value by knowing a medical topic.

We want somebody who's already knowledgeable on the topic to begin with.

But that viewpoint lost out. There were more people on the panel who said that

no, actually a competent medical writer needs to be able to come up to speed

quickly and write on virtually any medical topic needed and quickly. So that

was a surprise to me.

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the show notes.

Now let's get back to our conversation with Haifa and Don.

Practical Applications and Future Directions

Well, as we know, CME writing is very freelance heavy, and often writers are

working across several areas, not just one. So it's interesting that you saw that in

your model as well. And Haifa, you talked about the methodology that you

used, which allows for iterative feedback and consensus building, and you

talked about [00:14:00] the ways that panelists could engage with the responses.

With the responses that they saw from other panelists, were you able to track

shifts in perspectives across the three rounds? Did you see things shift changing

from round to round in terms of what people were prioritizing?

Haifa Kassis: yeah. So in terms of numbers ratings we did statistical analysis

for stability to see how the average has shifted and or the most part, most of the

areas that were rated stable made to the model. There were a few, really few that

shifted and those are hovering around the four. So like a little bit of shift. It's not

numerically like it's 3.95 going to 4.15, but it made a difference whether it made

it to the model or not. there were a couple of those. One of them, for example,

the AMA style [00:15:00] which I expect to be in the model, but in the first

round, I think it was 3.95, and then the second round, it went up to 4.15 and one

included. You could see some of the feedback and the rationales from the

panelists who were in favor, they said, it's like it's a no brainer. AMA style needs

to be there. But then other people said, well, have copy editors who make sure

the content and everything written, it follows the style. And others said, our

company has their own in-house style. So some other people, so thought it's

somebody's also job to do it. But, but I think because it was hovering around the

four, so it was more sensitive to shift. The other one that we saw is actually

going on the same theme, is being able to edit based on AMA style. [00:16:00]

So some people said that is a competency that belongs to copy editing, others

said actually the competency should be using a reference manager software not

actually doing it manually. So that one didn't make it to the, to the final model,

but you could see like some, some new nuance about how to word the

competency that suggested that would make a difference how people create it.

And also how people work in-house in their company or their employer, like

what they're used to, they would influence what they would consider, you know,

it's a no brainer versus, no, not really.

Alex: That's a great point. How did you come up with competencies to suggest

to the panelists in the first place?

Haifa Kassis: So before we the first we did a literature review. We looked at

competency models that related to our work. So we looked at the one from the

[00:17:00] Alliance, for example, that for the professionals, we look at the

competency model from the DIA for regulatory writers and publication writers.

So that were the place to see where there are areas that are in alignment with

what we see that we need as writers in our professional experience. And I'm

talking here, me and Don. And then we also looked at what education

workshops, courses, articles related to CME are out there that other people in

the last 10 years, for example, have done through AMWA or the Alliance.

And so they probably thought these are areas that CME writers need. So we

sampled from those as well. Our goal in the suggestions wasn't really to be

comprehensive, but rather the panelists somewhere to start thinking about the

writers need. And we got a lot of suggestions that we compiled we asked the

panelists to rate in the second [00:18:00] round.

That's a very thorough approach.

Alex: So Don, you mentioned four areas that distilled the range of competencies

that you identified for this model. Where do you think writers struggle the most

in terms of building these competencies?

Don: That's a great question. It tees up. earlier research that I did with the other

research partners, as you may recall for a number of years I was doing helping

to do a series of nationwide surveys on best practices for writing needs

assessments, writing CME needs assessments which kind of fell victim to the

pandemic.But for a while there I was doing these things annually and during 2018, asked

our survey respondents to please tell us about any. Poor practices that they had

seen in needs assessments written by others just to report to us what they were.

As you may recall, we wrote up the results of that research and they were

published in 2019 in the AMWA Journal.

And they were joint actually jointly published by, in the Alliance Almanac at the

[00:19:00] same time. And of the, there were 67 poor practices total and the

most numerous. We asked some reviewers to sort them into buckets and the,

bucket that ended up having the most poor practices in it was called sources and

referencing. This is my long way of answering your question. Where do I think

people writers struggle the most with respect to developing competencies? And

I would say sources and referencing that is, finding authoritative sources,

knowing when to cite them, knowing how to cite them. Citing them

appropriately, not over-citing but not under-citing and, basically finding

evidence, to document the existence of a need of an educational need. That's an

area where I think writers definitely struggle.

Alex: What would you say can be done to bridge those knowledge and skill

gaps?

Don: Early on Haifa and I realized that, writers are working in a macro

environment with [00:20:00] lots of pressures on us. I shouldn't say them. It's

us, Haifa and I are both medical writers. We're all medical writers, right? We

work in this kind of this pressure cooker sometimes.

And it can have something to do with a lead time. How much lead time are you

given what are the expectations? What's the model that you're being given to

follow? 'cause sometimes we update work by others, and if the previous writer

only cited every other paragraph then that's a poor model.

But that's the model you're being given to follow in the template, right? I think a

lot of it is norms. We need to develop norms of best practice that are followed.

And this is a step in that direction of developing, good, strong professional

norms in starting with sources and referencing.

Alex: So keeping with the idea of establishing norms, what do you see as next

steps for validating those norms and implementing them, not just in the medical

writing world, but also in the continuing education in the health professions

world to really kind [00:21:00] of embrace this model?

Haifa Kassis: So I think there's work to be done on an individual level and at

society level. So there's like the micro level that every writer can do. Now,

today, every writer can look at the list of competencies and ask themself how

confident are you in these? And if you are hesitant and you are not sure. Maybe

when you have a little bit time, you can seek out resources. Well actually Don

and I put together a toolkit just by what we found out there today, we were able

to connect the competencies to resources that are available right now from

AMWA the Alliance, the ACCME, the medical literature.

There are lots of things you don't know it's related to you unless you go find it

there are things that we can do individually. We can do individually also

advocate for ourself in the workplace. we're given unrealistic [00:22:00]

expectations, just tell people, this is unrealistic because these are the steps I

need to do to give you high quality product and it serves nobody. To waste time

on product that's not gonna get your grant funded. It's not gonna educate your

audience. You are just wasting time and resources for everybody. And we're in a

team it's, it's a team industry, so all of us have something to contribute and, but

we also have to communicate that to each other.

And, we feel like writers need to be empowered to speak up. In terms of

resources out there, like you mentioned, we have AMWA, we have the Alliance.

And in my experience they're open to suggestions. I serve on the AMWA

journal board. We have a section for theme called CE Craft Corner. So today I

used the model to select topics and ask writers to look at the competencies and

see which topics speak to them, where they see needs that we need to develop

more. [00:23:00] Resources, articles, and for writers to, to use, and it's, it's not

gonna end in one program. This, it's a lifelong learning for all of us.

Don: Haifa I realized when we were adapting our results for an audience at the

Alliance as opposed to an audience at AMWA, we were realizing that. There's,

at the Alliance you we're speaking more to the MedEd company executives,

people who hire the medical writers, who supervise the medical writers, who

maybe used to be a medical writer before, but now they're a strategic director or

a medical director or an executive.

And the question becomes then staff training. It becomes in-house corporate

training for a mid to large medical education company that wants to bring along

a, say a junior medical writer to an intermediate, to a senior. Medical writer and

maybe then to an education director or medical director, and that this

competency model can help with that. And that's a way that actually I know

from after we presented at the Alliance, a couple of medical education company

[00:24:00] executives came up to me and said, wow, this is great. We can't wait

to bring this back and start using it to train our staff in-house corporate training,

I think is a potential application here. And in that vein, I just wanna say how

excited I was at the last AMWA meeting to see that AMWA has developed an

apprenticeship program for regulatory writers. And that apprenticeship program

was developed with between writers and employers of writers working hand in

glove. Under the supervision of AMWA, developing an apprenticeship program

with steps in it for regulatory writers. And I guess what excites me is the

possibility of adapting that apprenticeship program for the much smaller

community of CME writers.

Haifa Kassis: The need is out there. It may not be explicitly under, you know,

training or something like that, but there is a need for resources and an

improvement in this area,

Alex: There is a need for resources and training for sure.

Emerging Competencies and Industry

Trends

Alex: What were the emerging [00:25:00] knowledge, skills, or attitudes that

panelists identified?

Don: So the emerging competency that I think we've identified is writing the

outcomes report as opposed to writing the outcomes question. And the reason

why we think it might be emerging is because it did not make it into the model.

But it was close. At the end of round two, it had a 3.8 rating, which was not

quite in the model. And at the end of round three it had a 3.7 rating. So it

finished, out of the model. there were 1, 2, 3, 4 panelists who argued strongly

for including. Writing the outcome report and there was only one panelist who

was arguing against its inclusion. Panelist eight wrote, I see outcomes reports as

a common deliverable for CME/CE writers and can plausibly be included as a

core competency. The other deliverables depend on where and how a CE writer

positions oneself in the [00:26:00] market. of these deliverables could be

acquired as part of specialized advanced training versus foundational panelists

13 wrote outcomes reports are very relevant because they are needed for all

activities. Panelist 15 wrote, I rated this deliverable 5 because outcomes reports

for educational activities are very important for our business. We need to be

able to demonstrate the value and effectiveness of a program to obtain funding

and future opportunities. And finally, panelist number 19 wrote, reports can be

created by the team for a good report that can be disseminated to stakeholders.

Someone has to write a thoughtful narrative. Not always medical writers are

involved in outcomes reporting, but this is an important deliverable. And then

the only panelist who argued against its inclusion was panelist number two, who

wrote the following. If it is meant that writers should be able to interpret

outcomes reports, I agree. this suggests that they should be able to write

[00:27:00] outcomes reports, then no. This is the job of an analyst.

The notion of a vanishing competency just came to us because you would think

that kind of, they come and go right? As this field changes, and the vanishing

competency we're proposing that it could be a vanishing competency. It has to

do with, writing the monograph or the CE certified article in a magazine in a

journal. It was a deliverable, it was a proposed as a deliverable, and the way we

worded the deliverable was certified journal articles or monographs, web or

print based. At the end of the second round, this was given a rating of 4.23, so it

would've been in the model if the exercises ended there.

But at the end of the third round, it got voted down and ended up with a final

group rating of 3.95 being just outside the model. And on that vote, there was

no one who voted for its inclusion. No one who, excuse me, wrote a [00:28:00]

rationale for a high rating, and one person wrote a rationale panelist, number 19.

Try to justify giving it a low rating, that panelist wrote not all CE providers do

this type of education. It could be important for some providers, if it is the case,

the skill could be developed. And I just wanna pair that with my own personal

experience as a medical writer in the CME space. It’s been a long time since

I've been asked to develop a monograph for a client, which used to happen

pretty frequently, it’s not happening at all for me right now. Now I'm not sure

whether that's just my personal business that ha having that experience, or

maybe that's more widespread in the field.

Alex: The field has increasingly moved into micro learning and micro activities

where that longer monograph type of deliverable doesn't really align with

shorter bursts of learning, does it? So that's interesting.

Conclusion and Contact Information

So final question, What are the next steps for both of you in relation to this

work?

Haifa Kassis: Well, we think [00:29:00] it's more increasing awareness of the

competencies that CME writers need connect more with, what writers

transitioning into the field feel that they are lacking? Like you said, we make

sometimes assumptions based on somebody's background, they, you should

know this, but maybe we need to do a little bit more our own needs assessment

to see where the gaps are where the areas of most need to focus on in the

immediate. Also more bridges with people who are willing to invest to help the

next generation of CME writers excel in their work.

Don: Me, I think the possibility that kinda lights my fire the most is to once

again, on a smaller scale, what AMWA has done for regulatory writers to try to

adapt it to the CME writing space. Just because, AMWA's already blazed a trail

there, so let's follow that trail, but adapt adapted a little bit. It's not that hard to

imagine, AMWA convening a MedEd company [00:30:00] executive forum that

talks about, Hey, how are we gonna cooperate in up-skilling the CME writers,

the medical writers on our staff, and how could AMWA help with that? And

how could that be funded? How could that even happen? 'Cause I know that

there are some MedEd company executives out there who have a quite

enlightened view toward the idea of staff training for in-house writing staff.

Alex: Well, here's to enlightenment. Where can listeners find you?

Don: My LinkedIn profile is probably the best place and the easiest place. And

we did publish our email addresses on the, it's an open access article that we

published, so you can find our email addresses there.

And I'll make sure to include the link in the show notes to the article that Don

and Haifa published in the Journal of CME, as well as how to contact them.

To Don and Haifa, thank you so much for doing this research to raise the bar in

competencies for CME writers, and thank you for sharing your wisdom and

insights with listeners of Write Medicine.

Don: Thank you, Alex. Thank you so much for this invitation. It's been a real

pleasure.

What I [00:31:00] loved about this conversation with Haifa and Don is how it

validates something we've known for a while. CME writing is a craft, a skillset,

and a strategic discipline, and it's time. We treated it this way, whether you're

hiring writers or building your own career as a writer. The competency model

we discuss today gives you a clear approach.

So here are three takeaways to leave you with. First focus on core

competencies. These aren't just buzzwords, they're what elevate content quality,

and writer credibility. Second, use the model to guide growth, whether you're

hiring, mentoring, or learning a shared language around competencies brings

clarity to expectations and outcomes. And third, invest in writers as partners.

When writers are equipped with the right tools and training, they become more

than content developers. They become collaborative experts in medical

education.

At WriteCME Pro, this is exactly the approach [00:32:00] we take, especially

inside WriteCME Accelerator, our skills-based portfolio program where we

focus on the four competencies that Don mentioned. These are the capabilities

that set great writers apart and help education providers build stronger teams.

If you find value in today's episode, please share it with a colleague who might

benefit. And if you're interested in developing these competencies in a

structured environment with expert guidance, check out our WriteCME

Accelerator program where we focus specifically on mastering. These essential

skills.

Thank you again to Haifa and Don for their important contribution to this field

and the way their research gives us all a common language and a framework for

excellence in CME writing. Until next time, keep writing medicine that matters.

[00:33:00]