Regulatory Writing - Is This Medical Writing Niche For You?

Expectations of a pharmaceutical applicant

Those who wish to pursue a career in the pharmaceutical industry are required to have a medical degree or an equivalent qualification in life sciences, nursing or pharmacy. Further studies such as postgraduate qualifications can be advantageous for a candidate wishing to pursue a career in the industry.

Some institutions of higher education offer a Master's degree specialising in Pharmacovigilance, which is highly valued by many employers within the pharmaceutical industry. The course will provide students with vital knowledge and understanding of what a career in the industry entails, including experience of risk assessment, report writing and signal detection. Students also learn about existing regulatory authorities.

Experience is important when getting ahead of other candidates fighting for a position in drug safety and Pharmacovigilance. Observing and partaking in the industry first-hand as a placement student, or even shadowing a nurse or pharmacist demonstrates an applicant's interest and willingness to work in a clinical background.

Careers in Pharmacovigilance

There are many different roles and job titles in regulatory affairs. Employees would typically begin their career as a drug safety associate, scientist or coordinator with sight to advance to specialty, senior and management positions in a particular area of Pharmacovigilance.

Medical writing, quality assurance and medical affairs are some of the main areas of focus for advanced employees; however these positions come with increased responsibility and require experience. Also if candidates are willing, there are many opportunities abroad focusing upon drug safety. These tend to be positions in larger companies and so offer further scope for progression into authoritative roles.

The yearly salary for a career in Pharamcovigilance can vary substantially, but earnings usually fall between the figures of £25,000 and £60,000 per annum. This depends greatly on factors such as the regulatory body, location, experience and position of responsibility.

Types of jobs in the pharmaceutical industry

Drug safety officers are responsible for tracking and observing reactions and effects during drug trials and studies. A report on the study is to be submitted to regulatory authorities, and once the report has been submitted drug safety managers must organise and review the reports to monitor the profile of specific medication products.

Drug safety physicians assess and attain information about the safety of the products. They are also required to carry out medical case reviews and evaluate product safety during clinical trialling.

When would-be freelance medical writers connect with me, they often ask for help getting that elusive first job. To get a job in the field of medical writing, it's important to first determine what kind of content you want to produce. As a medical writer, you can write in any of three broad categories: Regulatory, promotional, and educational. Regulatory writing, which is highly scientific, involves creating documents for submission to the US Food and Drug Administration.

Why do you need to determine what you want to write? Because the content you want to create determines who will hire you. A variety of companies employs medical writers or purchases that type of writing. Hospitals often need medical writers to create patient-education materials or marketing materials, whereas pharmaceutical companies and contract research organizations (CROs) hire medical writers who are skilled in regulatory writing.

Medical education, medical communications, and medical advertising agencies work directly with pharmaceutical companies and manufacturers of biologicals and medical devices to develop creative products such as videos, DVDs, slide decks, and flashy print materials for multiple audiences that will communicate key messages about the drug or device they are selling. These companies are generally full-service agencies that can do it all, from strategic planning to website development, to event planning and implementation. Because they offer such a variety of services, companies that specialize in medical communications have a great need for writers to keep up with the demands of their clients.