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TEACHING THE NEXT GENERATION OF 
REGULATORY MEDICAL WRITERS
Speakers 
Kim Jochman, PhD, RAC, Director, Medical Writing,  

Merck & Co., Inc, Rahway, NJ

Marsha Caton-Faustin, PhD, Director, Oncology Medical 

Writing, Merck & Co., Inc, Rahway, NJ

By Kavita Garg, MPharm
General Session Overview
The speakers at the 2021 American Medical Writers 

Association (AMWA) Medical Writing and Communication 

Conference, Kim Jochman and Marsha Caton-Faustin, dis-

cussed the importance of having standardized regulatory 

medical writing (MW) training programs, with a focus on the 

need for structured training programs for entry-level and ear-

ly-career regulatory MWs. The speakers also discussed how 

their organization adapted and implemented industry-level 

guidelines to develop training programs for new regulatory 

writers. Sharing this approach can help other organizations 

train new regulatory MWs and provide them with all of the 

essential skills required for performing this job.

Why Do We Need A Training Program For  
Regulatory Writers?
Caton-Faustin explained why organizations need a stan-

dardized training program for regulatory writers. People 

generally envision writers sitting at their desks, pounding 

away at the keyboard, and completing writing chores, espe-

cially in a regulatory or scientific writing career. Most people 

with scientific degrees know how to write and present sci-

entific data, but how many of them have had one-on-one 

coaching from a mentor or coach to bridge the gap between 

academic writing and regulatory writing? How many writers 

were given no guidance at all and learned to write regula-

tory documents by trial and error or by sink or swim?

 A regulatory or scientific writer, whether working for a 

sponsor organization, a contract research organization, or 

a medical agency, works with cross-functional teams, man-

ages multiple projects, and juggles a lot on daily basis, all 

while completing their writing tasks. Many organizations 

do not provide formal training to their writers, and experi-

enced writers have a varied baseline experience. Looking at 

the landscape of regulatory writing, it is important to pro-

vide MWs with thorough training so that they understand 

what they’re entering into and what they’ll be required to do 

in this dynamic profession. Developing skills in regulatory 

writing takes a long time. It’s tough to create a training pro-

gram that fits all writers because of the wide range of regula-

tory documents and leadership skills.

Developing a Structured Training Program
Jochman shared some of the resources that can be used 

to provide some guidance—the DIA’s Medical Writing 

Competency Model and the AMWA Recommended 

Training Outline for Regulatory Writers (Table 1).

Table 1. Brief Overview of Industry-Level Guidance

Available Industry-Level Guidance

DIA Medical Writing Competency Model (2018)1,2 AMWA Recommended Training Outline for Regulatory  
Writers (2020)3

•  Focuses on professional medical writing within the life 
sciences industry.

•  The working group consisted of experts from multiple com-
panies, medical writing specialties, and industry sectors.

•  Based on DIA Competency Model (especially Section 2) and 
experience of AMWA Workforce Training Committee.

Consists of 2 sections
1) Core work functions divided into functions, tasks, and 

activities:
a) Core role delivery 

eg, document preparation, development, and finalization
2) Knowledge and skills to successfully perform these  

functions for all MWs, regulatory MWs, and MW managers
a) Knowledge at different levels
b) Skills and abilities
c) Behaviors

3) Does not distinguish competencies of novice MWs from 
experienced MWs

Consists of
1) List of recommended training topics and priorities for training, 

from entry-level to more advanced levels
a) Core knowledge and skills

i) Drug development process
ii) Medical writing skills
iii) Technical aptitude
iv) Analytical skills

b) Documents (3 levels)
c) Soft skills

i) Management skills
ii) Personal development

2) List of independent reading for regulatory MWs
3) Customizable training checklist template

http://www.amwajournal.org


AMWAJournal.org     25Session Reports

 Jochman also talked about how their company used 
these guidelines to develop rotational training programs for 
entry-level MWs (Table 2).
 Caton-Faustin discussed their early-career development 
program, designed for employees from varied backgrounds, 
including those who have finished the entry-level MW pro-
gram as well as those who have come in from other orga-
nizations or even different departments within their own 
company (Figure).

Key Takeaways
In summary, a MW training program provides the foundation 
for entry-level and early-career writers to succeed in their 
careers. In a nutshell, the mentoring program may include

1. preparing a coaching framework and a partnership 
between the coach and manager,

2. rotations across several specialty groups within the 
MW department,

3. hands-on activities and shadowing experiences,
4. lecture-type training sessions, and

5. on-the-job training with careful coaching.

 The training program helps novice regulatory writers gain 

document-specific knowledge, general MW skills, a strong 
regulatory foundation using industry-standard resources 
such as AMWA and DIA guidance, statistical understanding, 

data interpretation ability, and leadership skills.

Kavita Garg is Director-Medical Writing at Saliegral Global Pvt 
Ltd. and is based in Singapore.

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

Author contact: kavita.garg@saliegral.com

Resources
1.  Clemow DB, Wagner B, Marshallsay C, et al. Medical writing 

competency model – section 1: functions, tasks, and activities. 
Ther Innov Regul Sci. 2018;52(1):70-77.

2.  Clemow DB, Wagner B. Marshallsay C, et al. Medical writing 
competency model – section 2: knowledge, skills, abilities, and 
behaviors. Ther Innov Regul Sci. 2018;52(1):78-88. 

3.  Yih L, Alexander L. AMWA Recommended Training Outline for 
Regulatory Writers. American Medical Writers Association; 2020. 
Accessed October 2021, https://info.amwa.org/hubfs/Offers/
regulatory-writer-training%20ebook/regulatory-writer-training.pdf.

Table 2. Case Study of Rotational Program for Entry-level MWs (<1-year experience)

Month 1 General orientation

Months 2-4 Rotation with assigned document* team Hands-on training, writing style, clinical trial data

Months 5-7 Rotation with clinical technical editing team Quality control review; clinical study report trainings and  
shadowing experiences also begin

Months 8-9 (6 weeks) Rotation with clinical content standards team Technical aptitude

Months 9-10 (3 weeks) Rotation with the document* team Health literacy concepts

Month 11+ End rotations; begin supporting MW team on 
regulatory documents

Hands-on training

*The first rotation is with the narrative team—narratives are the brief, participant-level documents that they learn at the beginning of the training program. The 
next rotation is with the teams writing informed consent documents. Shadowing opportunities for more complex documents, such as clinical study reports, are 
also provided throughout the rotational program. Overall, the training program includes core knowledge, soft skills, networking, and corporate culture.

Figure. Overview of training 
programs for early-career 
MWs (1-2 years’ experience). 
AMWA, American Medical 
Writers Association; MW, 
medical writer.

http://www.amwajournal.org
https://info.amwa.org/hubfs/Offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf
https://info.amwa.org/hubfs/Offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf



