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In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency's perspective. We invited reviewers at regulatory agencies to participate in an anonymized survey to evaluate the effect of document quality on the regulatory review process, assess awareness among document reviewers of the contribution of medical writers to the quality of regulatory documents, and identify current strengths and opportunities to optimize document quality. This article shares the survey results and discusses their implications for document quality, their impact on the regulatory review process, and the skills medical writers need to develop to bring value to this process. [ABSTRACT FROM AUTHOR]

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly recognized. The American Medical Writers Association (AMWA) formed a working group in 2020 dedicated to defining the value that regulatory medical writers contribute. The purpose of this article is to demonstrate the value that regulatory medical writers bring to the drug development and approval processes and to explore the ways in which efficiencies in regulatory writing can be increased. Current models for success provide guidance on training to help medical writers achieve their full potential, but obstacles and barriers to medical writing efficiency and document quality remain. Surveys developed by the AMWA working group revealed that (1) regulators who review clinical documents believed that regulatory writers improve document quality and (2) writers are frequently recognized for leadership and collaboration. Maximizing medical writing value requires thoughtful leadership and investment in training that includes both technical knowledge and soft-skill profficiency. [ABSTRACT FROM AUTHOR]

A high-performing medical writing team begins and ends with talented writers, editors, and leaders who understand their mission and their business. A panel of writers comprising the authors convened virtually on October 28, 2021, at the American Medical Writers Association national conference to discuss this topic. The topics of value proposition and business models; communication, leadership, and corporate responsibility; and financial acumen are reprised in this 3-part series. The series also includes thoughts from the authors looking to the future of the business of medical writing, including what we can do in the medical writing community to introduce these topics earlier in the medical writing career path. This Part 3 manuscript focuses on financial acumen. [ABSTRACT FROM AUTHOR]

Subcontracting can be the answer to a successful freelancer’s prayers, or the opportunity to work harder than you have ever worked before for less money than you made when you were a struggling newbie. The potential advantages of subcontracting are numerous, including being able to meet more of your clients’ needs, expanding your reputation and your repertoire, reducing your personal writing workload, and making more money – even while you are sleeping. But the potential disadvantages of subcontracting are also numerous and very real. Subcontracting puts your reputation on the line and out of your hands and exponentially increases your risk for problems ranging from cash flow and liability exposure to conflicts of interest. Subcontracting is not a decision you make lightly, but neither was your decision to freelance. It might just be your opportunity to soar. [ABSTRACT FROM AUTHOR]

The article offers information on the carriers in medical writing profession. Topics discussed include programs available both online and on-site in biomedical communications; mentions the jobs opportunities in the medical writing like working as a freelancer; and information on the experience of some medical writers who change their geographies, work environment or specialization and challenges for freelancing to employment.

A high-performing medical writing team begins and ends with talented writers, editors, and leaders who understand their mission and their business. A panel of writers comprising the authors convened virtually on October 28, 2021, at the American Medical Writers Association National Conference to discuss this topic. The topics of value proposition and business models, communication and leadership, and financial acumen and corporate responsibility will be reprised in this 3-part series, along with thoughts from the authors looking to the future of the business of medical writing, including what we can do in the medical writing community to introduce these topics earlier in the medical writing career path. [ABSTRACT FROM AUTHOR]

The article presents questions and answers related to medical writing including strategies for maintaining work/life balance and avoiding burnout and tools and techniques for time management.

The article features several American Medical Writers Association (AMWA) members and their views on whether freelance medical writers should be paid per project or per hour in 2013. Elizabeth L. Smith expressed her views on the complexity of estimating project hours. Brian Bass stated that rate may be per project or per hour, depending on the type of project that the writer is working on. Donna Miceli mentioned that the majority of clients prefer project fees.

Answers to a question about how freelance medical writers can improve the quality of a health-related writing on the Web are presented.

The article inform breaking into the field of medical writing cause problem, including need to be able to communicate information clearly and accurately in a variety of media.

An answer to a question is presented related to using social media to market freelance medical writing business.

The article cites the projects under 2013-2014 American Medical Writers Association (AMWA) president Brian Bass including the e-learning webinars, the education management system and the certification exam scheduled for the convention in San Antonio, Texas in 2015. It also mentions the blog in its website and the Medical Communications Inter-Organizational Summit involving the International Society for Medical Publication Professionals (ISMPP) and Society for Technical Communication (STC).

The article offers the author's insights of being the president of the American Medical Writers Association (AMWA) in 2013-2014. The author talks about the wide opportunities for young medical writers. He recalls his participation of his first annual conference in Baltimore, Maryland in 1995. He also emphasizes how mistakes can improve an individual.

The article offers information on the 72nd annual Conference of the American Medical Writers Association (AMWA) to be held in Sacramento, California on October 4-6, 2012.

The article presents answers to a question about the best and worst aspects of being a freelance medical communicator.

The article presents questions and answers related to medical writing, including the issue of payment for a medical writing contract with long duration and the things to do in cases of overlapping projects.

The article presents views of some writers on whether it is better to charge an hourly rate or to charge a project fee in freelance writing. According to Donna Miceli, charging an hourly rate would seem to be preferable but the big issue in it is that the client may have an unrealistic estimation of the number of hours a project should take. Meanwhile, Elizabeth L. Smith prefers the project-fee system since it allows the writer to invoice a greater amount of the total fee in the earlier stages of a project and set up progressive billings.