Toiling over the test tubes on a jumbled lab seat is regularly just half the tale of scientific research. Having a lab book brimming with splendid outcomes will just prompt Nobel Prizes (or on a more ordinary dimension, continuous financing) if the data is scattered among the more extensive scientific network.
The sheer volume of results created in the improvement of a
new medication is usually incredible for a pharmaceutical organization. It
makes it impossible to review without anyone else's input, especially when
review articles, conference reports, and other literature all must be set up
altogether for the organization to advance their product successfully and
morally.
This is the where proficient communication organizations
assume an imperative job. A typical interpretation is given to the job title of
a medical writer, i.e., the creation of manuscripts for peer-reviewed journals.
There is another component of medical writing i.e., regulatory writing that has
remained generally concealed. Each nation has its own governing body which
grants approval to a drug prior to its release in the market. So as obvious by its
name, regulatory medical writing deals with the composition of regulatory
documents.
A regulatory medical writer uses his knowledge of science
and research abilities to present the information and summarize the statistical
findings. He oversees producing a variety of clinical documents throughout the
complete life cycle of drug development, which includes the following array of
tasks:
- Characterizing & reporting data from clinical trials
- Exhibiting the data accumulated by clinical trials
- Composing regulatory submission documents for regulatory authorities
An efficient regulatory writer is immersed into a wide range
of tasks. They are well equipped to make a deal with the global regulatory
imperatives, analyzing documents in clinical research procedure like
Statistical Analysis Plans (SAPs), Good Clinical Practice (GCP) guidelines and
Risk Evaluation & Mitigation Strategy (REMS) documentation.
The road to regulatory
medical writing:
If you want to head into the world of medical writing and
establish yourself as an efficient regulatory medical writer, there are a few
perquisites that need to be looked after. Education is your main step towards
anything and relevant, most importantly.
So, if you are planning on becoming a regulatory writer, you
need to have:
- A degree in any stream of science like biology, microbiology, pharmacy, etc.
- A PhD in life sciences (though not mandatory)
It is not mandatory to be from a medical background, but it
would be beneficial for one to be as it eases the process of understanding the
complexities of science and write better.
Regulatory writers are
hired by:
- Pharmaceutical companies
- Clinical Research Organizations
- Health authority regulatory
- Medical Communication firms
- Healthcare journals & websites
The demand for medical writers is increasing rapidly in
pharma and healthcare sector. a medical writer can work for any of the
above-mentioned organizations or can also work as a freelancer. You need to
have the right skills to break into the industry.
Breaking into
regulatory medical writing with Turacoz Skill Development Program:
Turacoz Skill Development Programs focuses on building up
the skills of aspiring writers and enhancing the ones of professionals too. It
offers a wide range of courses related to medical writing, which helps an
individual to break into this industry and have a dream start.
The courses offered
are:
- Regulatory medical writing course
- Diploma course on medical writing & pharmacovigilance (6 months)
- Certificate course on scientific research & ethical consideration
- Certificate course on freelance medical writing
- Certificate course on scientific writing & conference presentation
- Trainings for academic institutes
All the courses mentioned above are designed with an aim to
bridge the competency gap and enhance the skills of the writers. The courses
are imparted by experts and professionals of their respective fields and focus
is laid on the overall development of the individuals and to make them
industry-ready.
The continuous assessment makes it easier for the writers to
track their progress and improve.
You can reach out to us here for further
details and register at trainings@turacozskilldevelopment.org
We are always ready to
guide you in your endeavors.
