Regulatory medical writers are key personnel in delivering quality regulatory documents that advance science and medicine, keeping patients safe and informed about the benefits and risks of pharmaceutical products.
Regulatory writing is an important and challenging medical writing specialty. AMWA’s Value of Medical Writing Workgroup identified quality, timelines, and interactions with stakeholders as common barriers to success.
AMWA’s Measures of Success Toolkit is a collection of resources that explores the regulatory writing environment, offering expert advice on achieving quality, managing timelines, and handling interactions with stakeholders.
Artificial intelligence (AI) and the subcategory machine learning (ML) are evolving quickly, and regulators around the world are working to respond to new opportunities while mitigating potential risks involving the technology.
Health is much more than numbers, medications, or a clinical diagnosis. A person’s health is affected by their environment and their lived experiences.
Before a medical device is marketed to the public, it needs to undergo a rigorous analysis to ensure that it is safe and effective.
Devices sold in the European Union need to meet the standards published by the International Medical Device Regulators Forum (IMDRF), a group of regulators from around the world.
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.
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.
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?
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.
A clinical study report (CSR) is a comprehensive regulatory report describing the data and outcomes observed in a clinical study.
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.
The economic fallout from the COVID‑19 pandemic has affected thousands of career paths, including many in the medical communication field. Whether you’re seeking new remote work opportunities or hoping to expand your skill set to further advance your career, consider pursuing writing in the pharmaceutical industry.
Melory Johnson, Owner and Principal Medical Writer, MJ MedComm, LLC, contributed to this article.
Whether you’re an established medical device writer or another type of medical communicator hoping to advance your career by adding a new skill, it can be helpful to brush up on best practices of medical device writing. Below, we outline the defining qualities of this niche, then describe how to succeed as a medical device writer.
This article, written by Peggy Boe, RN, and Barbara Snyder, MA, was originally published in the AMWA Journal.
Regulatory writers are often faced with ethical situations, though we may not always recognize them as such. The way we define ethical behavior in general is based on our personal upbringing, religious beliefs, culture, and environment. Ethical behavior in the workplace is further defined by our employers, professional organizations, and in some cases, even the government.
True or false:
Well-trained medical communicators bring value to the teams with whom they work.
I hope you answered true because that’s the right answer.
The key adjective of course is well-trained.
This article is based on content presented by Kent Steinriede, MS, at the AMWA Medical Writing & Communication Conference. It was originally published in the AMWA Journal.
“Find out what the story is,” Kent Steinriede stressed throughout his session about the quality control (QC) review of safety narratives. Steinriede highlighted the elements of the safety narrative, source documents and tools used in QC review, and tips for best QC work.