





































 V37 N2 / 2022 

©2022 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     30

ABSTRACT 
Demand for qualified medical writers is high and expected 

to continue to grow. With competition for experienced writ-

ers getting fierce, the need for alternative pools of talent has 

become evident. This article describes a pilot internship 

program developed at an independent clinical and regula-

tory consulting company designed to allow an alternate path 

for entry into the field of medical writing and to foster and 

retain talent. The internship will provide novice writers with 

relevant training, connections, and job experience to aid in 

attaining a position in regulatory writing. We discuss the chal-

lenges and opportunities discovered during the inaugural 

internship year and provide lessons for developing an intern-

ship program.

Demand for qualified medical writers is high and expected 

to continue to grow, with the global medical writing market 

expected to reach 7.7 billion US dollars by 2027.1 This 

market growth is driven in part by increasing investments 

in research and development by pharmaceutical compa-

nies and the rise in contract research organization out-

sourcing.1 Despite the demand for medical writers, there 

are few degree or professional development programs that 

prepare students directly for medical writing. Existing train-

ing programs comprise a combination of degree and certif-

icate programs and include the American Medical Writers 

Association (AMWA)'s Essential Skills Certificate program, 

the University of California San Diego Extension's medical 

writing certificate program, and the University of Chicago's 

medical writing and editing certificate program. Although 

these programs are useful for building technical knowledge, 

they often do not provide students with training in the soft 

skills or practical skills necessary for day-to-day work as a 

medical writer, including project management, professional 

communication, emotional intelligence, time management, 

and conflict resolution (Figure 1).

 Medical writing and the biotechnology industry gen-

erally have been experiencing a significant degree of staff 

turnover as part of the “Great Resignation” phenomenon 

that has followed the economic turmoil of the COVID-19 

pandemic.2 This competition for top talent, combined with 

significant growth, has left the biotechnology industry look-

ing for ways to increase interest in the field, create alter-

nate tracks for entry, and retain talented employees. These 

include mentoring college students interested in science, 

technology, engineering, and mathematics careers, hiring 

A Shoe in the Door: Regulatory Writing Internships for Promoting 
Diversity and Building the Talent Pool
Jordan E. Sedlacek, DVM, MPH, MAgr and Jeanette M. Towles, MA, RAC-Drugs / Synterex, Inc., Dedham, MA

EDITOR-AT-LARGE

Figure 1. Key attributes of successful medical writers. Figure  
previously presented at AMWA New England Brunch Roundtable 
Meeting, March 21, 2021.

Detail-
oriented

Organized/ 
disciplined

Creates and 
maintains plans or 

timelines
Identifies tools and 

processes to gain 
efficiency

Perceptive

Intuits where in the team 
lifecycle he/she is 
producing a document
Finds creative solutions to 
related challenges

Proactive

Outlines team vision 
for document

Analyzes project plan 
and identifies risks 

and mitigations

Curious

Keeps up to date with 
latest regulations and 
standards
Builds therapeutic or 
regulatory knowledge 
base for team

Flexible
Gives flexibility when 

possible

Communi-
cative

Communicates firmly 
when flexibility not 
possible

Collabor-
ative

Builds relationships 
with other 

departments
Forges alignment

Advocates

Te
ch

ni
ca

l s
ki

ll
So

ft
 sk

ill
 (E

I)

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AMWAJournal.org     31A Shoe in the Door: Regulatory Writing Internships

foreign-born talent, and developing a robust corporate  

culture of inclusion.3

 Many job positions in medical writing require multiple 

years of industry experience. A search of job postings on 

April 26, 2022, on Indeed.com for entry-level medical writ-

ing positions found that 14 of the first 15 listings required 

either an advanced degree (master's or above) or more than 

1 year experience; 7 of 15 required both. One job listing did 

not specify experience requirements.

 As is true for other medical writers in the field who are 

advanced in their careers, the senior leaders in our con-

sultancy benefited from colleagues who were willing to 

provide mentoring early in their careers, which has engen-

dered a sense of corporate responsibility in contributing to 

the development of the next generation of medical writers. 

Thus, Synterex has developed a medical writing internship 

program to foster new professionals and help medical writ-

ers enter the field of regulatory medical writing.

 Synterex partnered with a local agency promoting 

engagement in the life sciences for Massachusetts resi-

dents to create an in-house medical writing internship. 

This program provides sponsorship for 2 students from 

local colleges and universities. Two additional students 

may be sponsored if chosen from an associate degree  

program or from historically Black colleges and universi-

ties (HBCUs).

 Our findings from the first year of the internship pro-

gram indicated that the internship provided a potential 

pipeline for talent acquisition and retention. We hope that 

this outline of our experience may serve as a base model for 

implementation of an internship program for companies of 

any size considering starting a program and will lower the 

barriers for entry into the field for medical writers, in partic-

ular those from diverse backgrounds and historically disad-

vantaged communities.

METHODS
In early 2021, our team observed that there was a con-

current increase in requests from associates of staff and 

consultants for mentoring and tips on how to enter the 

medical writing field, a higher demand for medical writing 

resources, and fewer contract medical writing resources 

available for ad hoc projects. Although historically we had 

not hired many entry-level medical writers due to the fast 

pace of the work and lack of demand from clients for med-

ical writers with less than 5 years of experience, we began 

thinking of ways we could expand the medical writing talent 

pool in the long-term to eventually align client demand with 

interest from entry-level potential candidates.

 In May of 2021, our executive leadership team initiated 

development of an internship program. The team discussed 

goals and gathered requirements for the internship pro-

gram, including

• The scope of the program: did we want the internship 

to be focused on just medical writing, or would we 

open it up to other business functions?

• The geography of the program: did we want a national 

search, or did we want to anchor the program near 

headquarters?

• The logistics of the program: did we want a program 

that had a database of candidates we could search, or 

did we want applications to come directly to us to vet? 

Did we want to consider only students studying medi-

cal writing, or would we consider students studying in 

adjacent scientific fields?

 Ultimately, we decided that we wanted at least one of 

the intern roles to be open to IT and business operations 

in addition to medical writing because we felt provid-

ing opportunities on those sides of the business would be 

equally beneficial for potential internship candidates as 

well as being areas of the clinical trial talent pool that also 

need development and that may have potential employ-

ment needs in our company in the future. We also decided 

to anchor the internship program at our headquarters in 

Massachusetts, given the high concentration of our clients 

and staff in the state and the potential for in-person inter-

action (pandemic permitting) within our primarily virtual 

workforce. In addition, given that we wanted to ensure our 

first internship program would be successful and manage-

able in scope because we are a company comprised largely 

of working subject matter experts with lean administrative/

operational staff to vet applications, we opted for a program 

that had an existing database of interns we could search. 

Although this may present some limitations because the 

database is finite and not tailored to our core services, we 

felt this would be more manageable for us in the timeframe 

given to start up the internship program. Lastly, for medi-

cal writing interns, we opted to search for students in any 

scientific studies and try to identify writing-related or clin-

ical trial-related experience or interests on their profiles, 

rather than limit our search to only medical writing-related 

applicants, as we did not want to bias our resourcing pool to 

those students who already had exposure to medical writing 

as a career choice.

 In selecting an institution to partner with for intern-

ships, we wanted to select one that would be consistent with 

our hiring goals as a woman-owned and disability-owned 

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AMWAJournal.org     32A Shoe in the Door: Regulatory Writing Internships

business in terms of making sure that our workforce rep-

resents the people who will ultimately receive the medicines 

we work on. Massachusetts Life Science Center’s (MLSC) 

Internship Challenge program appealed to our mission 

because this program provides sponsorship of up to $8,160 

($17 per hour for up to 12 weeks) for 2 students from local 

colleges and universities as well as 2 additional students if 

chosen from an associate degree program or from HBCUs.

 Massachusetts, where our headquarters is, has a par-

ticularly robust life science industry that provided us with 

multiple partner organizations to consider. These partner-

ship opportunities may vary in areas with less biomedical 

infrastructure.

 A full-time employee was identified to act as the 

Internship Coordinator. This person acted as the main 

contact for the intern to answer questions and direct pro-

gramming. In our case, a junior staff member was chosen 

as someone who was able to relate to recent entry into the 

field. This team member also had more availability for ad 

hoc meetings, questions, and hands-on direction.

The Internship Coordinator then applied to the MLSC 

Internship Challenge program and searched in their data-

base for intern candidates who would fit our consultancy’s 

needs (educational background in the life sciences or infor-

mation technology, career goals in line with our areas of 

expertise, experience with relevant software systems, etc). 

Any student who meets the MLSC program requirements of 

Massachusetts residency and enrollment in an accredited 

college or university in Massachusetts or at an HBCU can 

submit a resume and cover letter to the program database 

for companies to search. Six potential applicants were iden-

tified for each internship, and the executive team reviewed 

their application materials. None of the medical writing 

internship candidates were from associate degree pro-

grams. Two of the IT internship candidates were from asso-

ciate degree programs. The Internship Coordinator reached 

out to one applicant for the medical writing position and 4 

applicants for the IT position and signed formal agreements 

with the medical writing intern who confirmed her interest 

in the program. None of the IT applicants contacted chose 

to pursue the internship opportunity.

 A single intern was hired for our pilot internship season. 

The intern was selected for her interest in pursuing regula-

tory writing professionally and her educational background 

in a regulatory affairs master's program. She was assigned 

to work 40 hours per week for the 12-week period with pay 

sponsored by the MLSC internship program.

 The executive leadership team worked with the 

Internship Coordinator to develop a curriculum that 

involved meetings and shadowing sessions to pair the 

intern with team members in various departments. This 

allowed the intern exposure to various facets of the business 

(Figure 2).

 We also agreed on critical success factors for the intern-

ship, including

• exposure to the concept of peer review and feedback,

• review and tips on developing their CVs for future 

opportunities,

• practicing summarizing medical content (eg, a regula-

tory guidance of interest),

• practicing public speaking (eg, discuss a science-re-

lated webinar they attended), and

• general work tips and day-to-day expectations for how 

to work and communicate in an office environment.

 The Internship Coordinator set up an orientation to 

convey these success factors, our company values and 

organizational structure, and expectations to the intern. 

The Internship Coordinator also set up a Microsoft Teams 

channel in which the extended team could create a queue 

of projects that would be both appropriate for the intern to 

work on and meaningful in terms of gaining experience. We 

also sent a company-wide email introducing the intern so 

that the wider team could get to know and connect with her.

 The intern was invited to weekly business operations 

meetings and assigned various internally facing projects 

such as the development of a company style guide. The 

intern was also assigned to externally facing projects with 

the supervision of a staff medical writer including social 

Figure 2. Components of the pilot internship.

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AMWAJournal.org     33A Shoe in the Door: Regulatory Writing Internships

media blog posts on health-related projects. These projects 

allowed the intern to gain experience with professional writ-

ing tools and reference citation management software.

 Although the intern did not work directly on client mate-

rials, she was involved as an observer in several active doc-

uments with Advance permission from the client and an 

active nondisclosure agreement. This allowed the intern to 

experience the collaborative authoring process and com-

ment resolution meetings. After the meetings, the intern 

met with the Internship Coordinator to discuss professional 

communication and conflict resolution tools.

 At the beginning of the internship, an exit interview was 

put on the calendar with the intern, as well as prospective 

regular meetings with select other team members to discuss 

specific business functions outside of the medical writing 

function. In addition, our own impressions and reflections 

on the internship were discussed at a regular internal meet-

ing at the end of the internship period. The intern com-

pleted training in Good Clinical Practice and our company 

standard operating procedures. Our intern provided feed-

back at her exit interview on the aspects of the program that 

worked and things that could have been done better. This 

feedback is reflected in the lessons learned section below.

LESSONS LEARNED
Consider Work Environment
Our company is a fully remote workplace, with team mem-

bers spread across the United States. This remote set-up 

may be an advantage for interns from areas without a devel-

oped biotechnology industry or for individuals without 

reliable transportation to and from work. The remote work-

place can present a challenge, however, as the intern will 

not organically get to meet the team in the course of their 

work, and at this juncture in their career development they 

most likely do not have existing in-office experience to draw 

from to make their own connections. We had to go out of 

our way to encourage team members to interact with the 

intern and to include her in ongoing projects.

 When hiring interns for remote work, recognize that in 

order to participate fully, interns may need to be provided 

with laptops and other tools to access company resources.

Setting Expectations
It is important that both the intern and the company set 

realistic expectations at the beginning of the internship 

both in terms of requirements and availability. Although our 

intern had 40 hours of availability in the week to dedicate 

to the internship program, it was understood and agreed at 

the outset that she also had a part-time job and a capstone 

project that cut into some of our regular business hours. This 

arrangement may not be feasible for all companies and all 

individuals, as it puts the onus on the intern to communicate 

their availability and the hosting company to work around it.

 Have a frank conversation with the intern prior to 

hiring on the expected hours and commitment that will 

be required in order to provide real, meaningful work for 

the company. In retrospect, we decided to make a formal 

job description for the internship position to state these 

expectations in writing. Recognize that if your internship 

requires full-time hours but does not provide a living wage 

or benefits, many individuals will need to maintain outside 

employment. Restricting outside concurrent employment or 

expecting interns to work for experience rather than pay will 

limit applicants to only those privileged enough to be sup-

ported by family or external means. The more you are able 

to invest in your intern, the more they will be able to invest 

in your company.

Provide Depth and Breadth in Programming
We found success with assigning the intern a mix of group 

work and independent projects. This allowed her to stay 

busy while allowing for feedback from other team members 

on rotations through each department. Having a long list of 

possible tasks, longer than you think you will need, ensures 

that the intern has other work to focus on if the Internship 

Coordinator is not immediately available to direct the intern 

to a new project.

 Try to identify independent, low-pressure tasks that 

are conducive to skill-building. We assigned our intern to 

writing blog-style health posts for our social media site. We 

challenged her to write the piece for different audiences 

(graduate level peers, high school students, children) and 

to bring the reading level of her work within range for each 

group. These assignments also allowed her to also practice 

using citation management software in a low-risk environ-

ment before applying those skills in a client-facing docu-

ment during collaborative authoring.

 A limitation of our program was having only one intern 

in our pilot program. In the future, we hope to host a cohort 

of interns at the same time. This would allow for more group 

work and collaborative learning between interns of similar 

skill levels.

Provide Resources for Learning
In order to facilitate independent work from your intern, 

curate resources for self-guided learning. Note that many of 

these resources already exist and do not need to be created 

in-house. There is a wealth of tutorial videos available on 

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AMWAJournal.org     34A Shoe in the Door: Regulatory Writing Internships

the Internet for the different software systems typically used 

in medical writing. Online training modules are available 

through AMWA and the DIA (see Additional Resources) 

 Provide regulatory guidance documents for the intern 

to review. If you can show a redacted example completed 

document similar to the one under development, this will 

allow the intern to build context for the current assignment. 

Consider building a library (analogue or digital) for your 

intern and other staff members to peruse. Try sending your 

intern on an Internet search for additional resources on a 

certain topic; you may be surprised at what useful tools they 

are able to bring back to the team.

Allow Time for Feedback and Questions
After periods of independent and group work, it is import-

ant to allow the intern time to digest and process the learn-

ing experience. We established a standing weekly meeting 

between the intern and the Internship Coordinator to dis-

cuss recent work. We also planned weekly meetings with 

each department to allow for broader exposure to the com-

pany. Given how busy team members are, it is strongly rec-

ommended to set these meetings up in advance so that 

programming for the intern can be prioritized. We were lim-

ited in the quick development of our internship program, 

and more advanced planning would have allowed for a 

more regular meeting schedule.

Not All Assignments Have to be Directly Related to 
Medical Writing
Medical writers often wear many hats in the course of their 

normal work. Foster these adjacent skills in your interns as 

well. Provide time to discuss soft skills such as professional 

development, time management, and remote working strat-

egies. Interns may have little experience with professional 

workplaces. Recognize that you may need to discuss and 

model professionalism in written and verbal communica-

tion as well as business etiquette. This may take the form of 

role-playing professional communication and conflict res-

olution scenarios. Consider offering training in emotional 

intelligence courses that will serve the intern in their future 

career, regardless of what they pursue.

Consider Future Benefit to the Intern
Try to provide the intern with experiences that will not only 

benefit the company but will benefit the intern going  

forward. This may take the form of resume-building  

experiences such as authorship or editing credit, industry 

connections for future professional development opportu-

nities, or, more tangibly, a position within your company if 

possible. We had a very positive experience with our first 

intern, and we were able to hire her into a part-time proj-

ect management position while she completed her gradu-

ate degree. She now works for us as a full-time employee. 

She has been able to smoothly transition into these new 

roles due to her previous experience during her internship 

and was able to make an immediate impact on our team. 

If you are not able to hire your intern, consider remaining 

in contact so that you can continue to provide mentorship, 

advice, or job references after the internship is complete.

PLANS FOR FUTURE INTERNSHIP DEVELOPMENT
We found our pilot internship program a resounding suc-

cess. We are looking to expand the program in 2022 to take 

on multiple medical writing interns and have developed a 

pilot information technology internship position as well. We 

are looking to partner with other local life science outreach 

programs to reach a more diverse student base of first-gen-

eration college students. We also hope to partner directly 

with local colleges and universities to identify interested 

students. Many students plan their summer and semester 

experiences months in advance, and it is important to get 

your internship information to them early if you would like 

to be considered.

 In the future, we would like to expand outside of our 

local area to partner with HBCUs, tribal organizations, and 

international student groups to cast a wider net for our 

internship candidates and provide opportunities for entry 

into medical writing to communities that have previously 

been under-represented.

 Building on the success of our internship program, we 

are also developing a fellowship program to function like a 

medical writing apprenticeship. This program would be lon-

ger-term, a full year as compared with the 12-week intern-

ship. The fellowship is targeted to individuals who have 

completed an advanced degree in life sciences within the 

previous 2 years. This program provides a full-time, bene-

fited fellowship position for individuals who are committed 

to entering the medical writing profession but do not have 

relevant job experience for entry-level positions.

Additional Resources
DIA Learning Solutions: https://www.diaglobal.org/
en/learning-solutions

AMWA Courses: https://info.amwa.org/medical-
communication-essential-skills-for-success

http://www.amwajournal.org
https://www.diaglobal.org/en/learning-solutions
https://www.diaglobal.org/en/learning-solutions
https://info.amwa.org/medical-communication-essential-skills-for-success
https://info.amwa.org/medical-communication-essential-skills-for-success


AMWAJournal.org     35A Shoe in the Door: Regulatory Writing Internships

CONCLUSIONS
Given demand for experienced medical writers and the 

dearth of qualified applicants, we have presented a basic 

model that small- to medium-size companies can custom-

ize to develop an in-house training and internship program 

to attract and retain medical writing talent from a diverse 

background.

Author declaration and disclosures: The authors note no 
commercial associations that may pose a conflict of interest in 
relation to this article.

Author contact: jsedlacek@synterex.com

References
1. Grand View Research. Medical writing market worth $7.7 

billion by 2027 | CAGR: 10.9%. Grand View Research website. 
Published April 2020. Accessed February 9, 2022. https://www.
grandviewresearch.com/press-release/global-medical-writing-
market

2. LaHucik, K. 2022 forecast: talent war in life sciences, salary 
inflation in C-suite builds to 'negative feedback loop'. Fierce 
Biotech website. Published December 22, 2021. Accessed 
February 9, 2022. https://www.fiercebiotech.com/biotech/2022-
talent-war-life-sciences-salary-inflation-c-suite-builds-to-
negative-feedback-loop

3. MassBioEd. Key insights from breakout sessions. 2021 MassBioEd 
Life Sciences Workforce Conference; August 2021; Cambridge, 
MA. Accessed February 9, 2022. https://www.massbioed.org/
wp-content/uploads/2021/08/2021-Life-Sciences-Workforce-
Conference-Breakout-Group-Summary.pdf

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http://www.amwajournal.org
https://www.grandviewresearch.com/press-release/global-medical-writing-market
https://www.grandviewresearch.com/press-release/global-medical-writing-market
https://www.grandviewresearch.com/press-release/global-medical-writing-market
https://www.fiercebiotech.com/biotech/2022-talent-war-life-sciences-salary-inflation-c-suite-builds-to-negative-feedback-loop
https://www.fiercebiotech.com/biotech/2022-talent-war-life-sciences-salary-inflation-c-suite-builds-to-negative-feedback-loop
https://www.fiercebiotech.com/biotech/2022-talent-war-life-sciences-salary-inflation-c-suite-builds-to-negative-feedback-loop
https://www.massbioed.org/wp-content/uploads/2021/08/2021-Life-Sciences-Workforce-Conference-Breakout-Group-Summary.pdf
https://www.massbioed.org/wp-content/uploads/2021/08/2021-Life-Sciences-Workforce-Conference-Breakout-Group-Summary.pdf
https://www.massbioed.org/wp-content/uploads/2021/08/2021-Life-Sciences-Workforce-Conference-Breakout-Group-Summary.pdf



