Maximizing the Value of Regulatory Medical Writing

Are you a regulatory medical writer who is concerned about proving your mettle?

Regulatory medical writers play a critical role in the drug development and approval processes. Yet their role is often misunderstood and undervalued.

A Critical Link: What Medical Communicators Should Know about Preparing AMCP Dossiers

What role do medical communicators play in the world of health care reimbursement? 

In the United States, health care reimbursement and access is a complex process that involves multiple parties known as payers (or payors): insurers, national health entities, and other decision-makers. The goal is to provide effective health care to patients while also weighing the costs of drugs, devices, and procedures in order to develop plans for formularies.

Medical Communicators and Medical Advisory Board Meetings

Pharmaceutical companies look to medical advisory boards to help shape the big‑picture aspects of their work. Are their products benefiting patients and health care professionals? Can they do a better job of meeting the needs of patients?

Package Inserts: A Medical Writer’s Primer

Medical writers can find vast amounts of information about prescription drugs and biologics from a variety of resources, such as scientific publications, electronic databases, and free online content from sites such as drugs.com.

A challenge for medical writing professionals is sorting through these resources to find information that is accurate and acceptable to use as a reference source when writing content that will ultimately go through medical‑legal review. 

What Is a Clinical Study Report? A Medical Communicator’s Guide

A clinical study report (CSR) is a comprehensive regulatory report describing the data and outcomes observed in a clinical study.  

4 Best Practices for Clinical Protocol Writing

As a regulatory writer, you must stay updated on new policies and evolving best practices for highly technical documents. Continuing education is important for both maintaining and advancing your career. That includes brushing up on everything from medical device writing to pharmaceutical writing. Below, we review the expectations for protocol writing, then follow up with four best practices for success as a regulatory writer who specializes in these types of documents.