Portfolio

This section features a collection of my blog posts, writing samples, and practice documents. It includes recent and earlier work showcasing my learning journey, writing skills, and growing experience in regulatory medical writing.

Writing Lay Summaries: What I Didn’t Expect to Learn as a Regulatory Writer

27/November/2025

From “Raw TFLs” to Regulator-Ready Narratives: A Medical Writer’s Walkthrough (Antifungal Case Study) 

10/September/2025

Writing Briefing Documents for Scientific Advice Meetings: A Step-by-Step Guide Using Azidomyxin

08/August/2025

Clinical Overviews and Clinical Summaries in Regulatory Submissions – A Regulatory Writing Walkthrough with Oncometherin

26/July/2025

Understanding Development Safety Update Reports (DSURs): A Dermalexiin Case Study 

16/July/2025

Understanding Pre-Clinical Modules of the CTD – A Dermalexiin Case Study 

02/July/2025

The Investigational Medicinal Product Dossier (IMPD): An Overview from a Developing Medical Writer

23/June/2025

Writing Safety Updates in Regulatory Medical Writing: An Overview of RMPs, DSURs, PADERs, and PBRERs from a Developing Writer’s Perspective

13/June/2025

Medical Writing in Oncology: What Makes It Unique?

09/June/2025

Understanding the Paediatric Investigation Plan (PIP): How It Differs from a Clinical Trial Protocol 

02/June/2025

Understanding the CTD: Where Clinical Data Meets Regulatory Writing 

29/May/2025

From Numbers to Narrative: Learning to Understand Clinical Data as a Medical Writer 

22/May/2025

Writing the Participant Information Sheet: A Practical Introduction

15/May/2025

Writing for Ethics Committee Submissions: Practical Insights from a Developing Writer

14/May/2025

Understanding Protocol Amendments: A Beginner’s Perspective 

08/May/2025

Understanding the ICH Guidelines: E3, E6, and E8 from a Medical Writer’s Perspective 

05/May/2025

Basic Results and Trial Disclosure Reporting: Transparency in Action

30/April /2025

Lay Summaries in Clinical Trials: A Beginner’s Perspective on Making Research Understandable

29/April/2025

Clinical Trial Protocols and Clinical Study Reports (CSRs): A Beginner’s Perspective 

28/April/2025

Investigator’s Brochure and Updates: A Beginner’s Guide 

26/April/2025

Writing Patient Narratives in Clinical Trials: A Beginner’s Guide 

24/April/2025

Understanding Informed Consent Forms (ICF)

24/April/2025

Starting Somewhere

21/April/2025