Medical writers are critical in detailing, documenting, and communicating clinical research findings that inform decision-makers, impact health outcomes, and save lives. The global biopharma industry is growing unprecedentedly, with new interventions going through clinical trials and regulatory submissions more rapidly than before. Opportunities for medical writers continue to grow and evolve, with work ranging from drafting peer-reviewed articles reporting on clinical trials to regulatory writing and educating healthcare professionals and patients about novel treatments.

To ensure that breakthroughs in research do not remain a best-kept secret, let’s walk through how to select a medical writer who can produce clear, compliant, and high-quality documentation appropriate for the intended audience.

 

Medical Writers: Indispensable Partners in Research

The medical writing profession requires knowledge in both writing and the rigor and detail of clinical research. With the constant advancements in medicine and healthcare, the need to effectively convey research findings is growing. Medical writers are increasingly in demand to communicate scientific and clinical evidence to many audiences, from clinicians to payers, policymakers, and patients. Among the different types of medical writing are medical communications, which focuses on communicating the value of a health intervention to other stakeholders, and regulatory writing. Regulatory writers are tasked with gathering, organizing, and interpreting scientific research findings and literature and presenting them to global regulatory agencies.

Throughout a clinical trial, medical writers cooperate closely with clinicians, research scientists, and other subject matter experts (SMEs) involved in the study for clarity and accuracy in every document while ensuring compliance with regulatory, publication, or other guidelines. Formats include print and electronic publications, multimedia presentations, and website content. Medical writers can help with study protocols, consent forms, trial reports, regulatory submission documents, scientific journals, and more.

Based on our extensive experience with medical writing and medical writers, here are some tips for selecting the writer that best matches your needs.

 

10 Tips for Selecting a Medical Writer for Clinical Research

Selecting a medical writer who can accurately and effectively convey the complexities of clinical research is crucial. A skilled medical writer not only ensures compliance with regulatory standards but also enhances the presentation and clarity of your research findings. Here are ten essential tips to help you choose the right medical writer for your clinical documentation needs.

 

1. Ensure Core Knowledge and Skills

High-performing medical writers are skilled in gathering, organizing, interpreting, assessing, and communicating often complex information to different audiences. These include target users, e.g., healthcare professionals, specific patient populations, and the general public; internal stakeholders (of biotech and pharmaceutical companies) such as marketing teams and sales representatives; and non-clinician stakeholders, e.g., hospital purchasers, insurance payers, and public policy officials. To develop impactful material for these audiences, medical writers must know industry trends, pipeline projects, the regulatory landscape, product development, and manufacturing trends, amongst others.

Medical writers must have sharp analytical skills to read and understand information and data from various sources before translating them into documents in a language and with deliverables that are distinct for each target audience. Additionally, choose a medical writer with critical thinking skills, as these skills help enhance the ability to interpret scientific data and formulate and ask the right questions when composing a document.

Look for a medical writer with a strong educational background in a relevant field, such as life sciences, pharmacy, or medicine. Advanced degrees or certifications in medical writing, such as those from the American Medical Writers Association (AMWA) or the European Medical Writers Association (EMWA), are highly desirable.

 

2. Search for Industry Experience

Experience in the clinical research industry will be important when searching for a medical writer.

Medical writers need to be well-versed in the resources, regulations, and guidelines to produce high-quality, compliant documentation effectively, including extensive knowledge of the latest International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Other guidelines include regulatory writing guidelines by agencies like the U.S. Food and Drug Administration (FDA), scientific publications guidelines, Good Publication Practice guidelines, ethical guidelines, a familiarity with research ethics, and position statements such as that jointly developed by the American Medical Writing Association (AMWA), European Medical Writers Association (EMWA) and International Society of Medical Publication Professionals (ISMPP). In addition, medical writers must be aware of and use the prevailing style, e.g., as described by the AMA Manual of Style, covering word usage, precise terms, and patient-sensitive language.

Select a medical writer who has experience working with CROs, pharma, medical devices, biotech companies, or within the specific therapeutic area your research is in. This should ensure the writer is familiar with the terminology, regulatory requirements, and scientific nuances needed to produce high-quality documents.

 

3. Review Writing Samples

Always ask for writing samples. Evaluate these samples for clarity, accuracy, and appropriateness of style for your target audience. Look for documents similar to those you need, such as clinical study reports, protocol writing, or patient information leaflets.

 

4. Consider Regulatory Knowledge

A good medical writer should have an in-depth understanding of the regulatory environment relevant to clinical research. They should be familiar with documents required by bodies like the FDA or EMA and understand how to structure submissions to meet these guidelines.

In addition to strong core knowledge and skills, prioritize medical writers who invest their time and energies in staying current with new developments in clinical research. Areas that deserve attention include evolving clinical trial designs, plain language principles, visual communication, and innovations in technology and techniques. On evolving trial designs, medical writers need to keep abreast of clinical trial designs in precision medicine, innovative trial designs such as adaptive trials, and the growing emphasis on patient-centric trials, amongst others.

 

5. Evaluate Communication Skills

Effective communication is critical. The writer should be able to explain complex medical terms in a clear and understandable way. They should also be responsive and adaptable to feedback, ensuring a collaborative and efficient working relationship.

 

6. Check References and Recommendations

References from previous employers or clients can provide insights into a writer’s reliability, expertise, and work ethic. A reputable medical writer should have no problem providing references upon request.

 

7. Look for a Detail-Oriented Approach

Precision is key in medical writing. Small errors can lead to significant misunderstandings. Ensure that the writer pays meticulous attention to detail and has a strong commitment to accuracy.

 

8. Assess Project Management Skills

Medical writing often requires juggling multiple tasks and adhering to strict deadlines. Look for a writer with excellent project management skills who can handle complex timelines and deliver quality work on schedule.

 

9. Determine Flexibility and Adaptability

Research projects can evolve, and regulatory guidelines can change. A medical writer should be flexible and able to adapt to new information or altered project scopes without compromising on the quality of their output.

 

10. Ensure Compatibility with Your Team

Finally, the writer should be someone who can seamlessly integrate with your team. Compatibility in working style, communication preferences, and overall project goals is essential to ensure a productive and harmonious collaboration. Ensure a sense of professional ethics as well.

Awareness and application of ethical guidelines and adherence to research ethics are essential for all clinical research staff, and medical writers are no exception. Select medical writers who know the steps to ethical decision-making and uphold ethical clinical research principles.

 

TFS Medical Writing

For the efficient and consistent development of high-quality documentation, medical writers like the team of global medical writers at TFS HealthScience work in close cooperation with study teams and subject matter experts (SMEs). As part of a top global mid-sized contract research organization (CRO), TFS medical writers leverage their expertise while accessing knowledge and experience across functional teams, including regulatory, safety, data management, and biostatistics, ensuring the accuracy and compliance of each document. To further instill trust in customers, TFS ensures that its medical writing team participates in regular specialized training and has access to the latest medical writing tools, technology, and practices.

TFS believes that the quality of documentation can influence the flow of a clinical study. TFS medical writers are dedicated to providing the documents you need to confidently support your drug’s development journey. You will receive documents written clearly in the languages you require that comply with all ICH guidelines and regulatory requirements.

For clinical trials, the TFS expert team of writers supports you in every step of the study from beginning to end. They are skilled in writing protocols and clinical study reports (CSRs) with a complete scope of study types, depending on the primary goal of your study. For medical communications, TFS medical writers help translate complex data and concepts into messages that target audiences can understand.

To learn more, contact a team member today!