Whether you’re new to the field of medical and health writing or thinking of switching specialties within medical writing, it’s helpful to know what a day in the life of a medical writer in your chosen specialty looks like.
In this post, we’ll give you an inside peek into working in regulatory medical writing.
Swati Biswas PhD is a lead (regulatory) medical writer at a pharmaceutical company in the US. She generously shared the details of her work with us in this interview.
A typical day in regulatory writing
Swati starts her day by checking her e-mail and responding to any feedback or new requirements. She usually has her projects planned, but sometimes project timelines change since medical writing is a highly dynamic field.
Swati spends a portion of her time attending training sessions for new software or documents required by the company. She also works on administrative tasks such as reports for the company.
The types of projects in regulatory writing
Swati’s work involves writing regulatory documents required for clinical trials to approve new drugs. Examples include clinical study protocols for clinical trials, clinical study reports (CSRs), informed consent forms (ICFs), investigational new drug approval (IND) applications, and investigator’s brochures (IBs).
Companies usually have templates for the required documents that you tailor your work to. Document requirements are set by the regulatory bodies such as the FDA in the United States and the EMA in Europe. She says that the work you are exposed to depends on the projects presented to you on the job.
The most important skills needed for a job in regulatory writing
Swati divides the skills into technical skills and soft skills. Technical skills include research skills, writing skills, project management and mastering Microsoft word and other software programs needed according to your company. Regulatory writers usually work with biostatisticians, so basic statistical knowledge is needed in order to correctly interpret statistical information. The soft skills needed are mainly communication skills that allow you to work with other team members.
A lot of the skills are learned on the job through training, practice and learning from colleagues. Swati advises reaching out for help when trying out something new—medical writers are usually a cooperative bunch!
Qualifications required for regulatory writing roles
Swati says that although having a PHD may be preferred by companies, there are many senior writers with bachelor’s degrees in science fields who have earned their place through years of experience. She adds that getting a postgraduate degree teaches you many transferable skills that serve you well in regulatory writing. Academic publications are also beneficial when applying for regulatory writing jobs. Showing recruiters or hiring managers that you have the right skillset will improve your chances of success in landing an opportunity.
The most challenging aspect of the job
Deadlines are usually a challenge, especially when a project has several steps that are dependent on each other and assigned to different members. Delay in one step causes a delay in the whole timeline, which may happen due to the difference in priorities and workload of each team member.
The best aspect of the job
What Swati likes most about her job is contributing to the healthcare field by helping companies develop new medications. This eventually helps patients, which is the cause that keeps her going.
Advice for someone venturing into the field of regulatory writing
Swati advises writers to work on their skills, update their LinkedIn profile, network, and try to gain practical experience. There are many available courses teaching design and interpretation of clinical trials, good clinical practice guidelines, ICH guidelines, and the drug development process. There are also more specialized courses teaching how regulatory documents are written by AMWA, EMWA and others.
Swati says that it’s important to update your LinkedIn profile and highlight the skills you have, the courses you’ve taken and the position you are looking for. You can also work with recruiters to find a role that is suitable for you.
Networking is essential, and you can achieve that by attending workshops and conferences (even virtual ones) to meet other writers and employers in regulatory writing.
Swati suggests trying to get practical experience according to your background and what is available for you. For example, if you have knowledge in the medical field, you can reach out to colleagues and professors working on clinical trials to gain practical experience. You can offer to help with writing or editing. Some companies hire medical editors, and editing would give you a chance to see the documents prepared, which may, later on, lead to a writing role.
She also suggests looking for local contract research organizations (CROs) to look for opportunities.
We hope we’ve given you an idea about working in the field of regulatory writing, and we’d like to thank Dr Biswas for her valuable insights.