5 Tips for Getting job into Regulatory Medical Writing - Click here to see all - Freshers Call us now @ 092 898 70004 to Join the jobs in Pharma Industry - GET TRAINED GET HIRED - Come to our office @ CLINI INDIA NOIDA & experience why other Job seekers approaching us - Don't just believe, feel the difference "D"

 
 

CLICK HERE TO FILL A ENQUIRY FORM, To resolve your queries

 

Regulatory writing is a specific branch of medical writing, and as is often the case with other aspects of medical writing, it can be a difficult one to break into. Companies don’t typically want to hire writers without regulatory experience, yet at the same time, it’s tough to get the experience when nobody will hire you!

To maximize your chances of being hired, be sure to follow these basic points:

• Understand what’s involved: You must like science, have good mathematics skills, know how to write well, and be able to sit at a computer for at least 8 hours each day. But you also need to be social enough to interact with colleagues and clients.
  s 
• Have good computer skills: You need to be an expert in Windows (make sure you can efficiently manage files and folders, and that you know how to control where your documents end up when you save them) Word (make sure you know how to apply styles to paragraphs, and can paste from different source without corrupting the styles; that you can switch between portrait and landscape pages, insert cross-references, and handle a table of contents; that you have the necessary skills to make complex tables) and Excel (know how to use built-in functions such as sum, average, standard deviation) – practice makes perfect, so make sure you can work swiftly and correctly. And use a PC – Macs are not often used in the regulatory field.
  s 
• Develop an understanding of language fundamentals and style-guide conventions: Know when to use commas, hyphens, and other punctuation. Study the AMA Manual of Style (in particular Sections 2,3, and 4) – most pharmaceutical companies have adopted modifications of this as their writing style.
  d 
• Develop excellent proofreading and editing skills: Find proofreading and quality-control tests online. Regulatory writers often have to do quality control as part of their work, so you should practice these online tests over and over until you can catch every error.
  d 
• Learn how to write well: Many writers swear by Strunk & White’s “The Elements of Style”. Practice writing for at least one hour each day. Get other writers to critique your work. Take as many opportunities as possible to write – for your local church or community group, local newspaper – any chance you can take! Write simply and clearly.

d

Online resources can be utilized, and don’t forget your local library for books. Pursuing as many of these options as possible will only further increase your chances of being hired, and will leave you better prepared to learn regulatory writing – when you are hired, you’ll be able to concentrate on learning the content of the profession rather than beginning to learn to use Windows and Excel effectively, etc., or learn AMA writing style.

So the future for writers wanting break into the regulatory field may be opening up! Be sure to check out these options if you’re looking to get into the regulatory writing field.

 g

And Finally……

Anyone who wants to get into regulatory writing needs to produce a CV that is well-structured and correctly formatted – otherwise it’s unlikely that anyone will trust you with regulatory documents.

It’s also important for writers to know what they are getting into in this particular field of writing. Regulatory writing is not just about medical writing – but also about looking for relevant patterns in data, and recognizing what is important. So if you don’t enjoy statistics and data evaluation, or complex tables, the regulatory writing field may not be the career for you.

Must have some awareness of the regulatory aspects of the pharmaceutical industry – simply having qualifications such as a medical degree or a PhD are not necessarily going to immediately qualify you for this branch of writing. Guidelines differ across different areas, such as veterinary products, human pharmaceuticals, and the medical device industry. They also differ across different geographical locations. So another piece of advice that he offers when applying for a job, is to be aware of what the specific company does – check what products it has, and the regulatory environment in which it operates.

 



Overview of Regulatory Medical Writing for Pharmaceuticals:

 

Regulatory Writing :

Regulatory writing is one of the most difficult subfields of medical writing to enter. Regulatory writers are responsible for organizing large volumes of clinical data into documents that are submitted to the FDA at various phases of clinical development. These documents are extreme lengthy and complex. In addition, they must be written following specific guidelines that are difficult for the novice to learn. Individuals in this profession must be highly attentive to detail, comfortable in the role of project manager, and able to meet strict deadlines. Mistakes in regulatory filings can be extremely costly for a pharmaceutical or medical device company. To get you started, I have written a very basic overview of the pharmaceutical clinical trial process, common acronyms, and links to useful websites where you can learn more.

Overview of Clinical Trials

In order for a new therapeutic or medical device to be approved by the FDA, comprehensive studies must be performed to evaluate the safety of a compound, establish the optimum dose, and determine if the investigational product is efficacious. These studies are collectively referred to as clinical trials.

• Phase I trials are typically very small, with only a few participants. The goal of these studies is to establish a safe dosage range, identify side effects, and evaluate efficacy. These studies are often first-in-human, meaning that all previous work was performed in animal models.

• Phase II trials involve a larger group of individuals to further evaluate a drugs' safety and efficacy.

• Phase III trials involve a large number of participants and aim to evaluate efficacy, safety, and side effects. Typically, the drug or treatment is compared to an already existing therapy.

Superiority vs. non-inferiority studies - The hypothesis of a study can be either to demonstrate that a drug is more effective (superior) or equally effective (non-inferior). Generally speaking, it is more difficult to convince the FDA that a treatment is superior than to establish that it is equally as safe and effective as the treatment currently on the market.

Following Phase III trials, a pharmaceutical company submits the New Drug Application (NDA). The FDA reviews this large document, which includes all information that has been collected about the drug over the course of development. If the FDA approves, the company will begin to market the drug.

• Phase IV trials are conducted after the drug has been released onto the market. These studies may identify rare side effects that could not be detected in the earlier trials. In addition, data can be collected to understand if the drug behaves differently in various populations.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Clinical trial design, execution, documentation, and reporting standards used to vary greatly depending upon the location of the trial. This made it difficult to submit a new therapy or device for review to the regulatory agency in a different country. Not only was the formatting of the regulatory document highly variable, but the standards of trial design, data collection, and data analysis were also inconsistent. To combat this, the International Conference on Harmonization (ICH) was born in 1990 as an organization aimed at facilitating global medical product development. Three parties - the European Union, Japan, and the United States - agreed to the terms. As a result, all regulatory professionals in the participating countries must adhere to the ICH guidelines. This is not to say that the regulations in each of the participating countries are identical. Submission of a drug tested in Europe will still have to meet the specific requirements of the US FDA. However, if the researchers adhered to ICH standards, the trial results should be of sufficient quality and be easily transferable to the FDA submission format. If you are considering a career in regulatory writing, it is essential to familiarize yourself with these documents. To date, there are 45 guidelines, which are frequently being modified due to the active dialogue between ICH members. The most common ICH guidelines a beginning regulatory writer needs to know are summarized below.

E1, E2 - Clinical Safety

E3 - Clinical Study Reports (CSR)

E4 - Dose Response Studies

E6 - Good Clinical Practice (GCP)

E8 - General Considerations for Clinical Trials

E9 - Statistics

Common Acronyms

In the world of regulatory affairs, acronyms are king. See the translation of common terminology below.

SOP - Standard Operating Proceedures

CSR - Clinical Study Report

IND - Investigational New Drug

NDA - New Drug Application

BLA-Biologics Drug Application

SAP - Statistical Analysis Plan

CTD - Common Technical Document

IRB - Institutional/Internal Review Board

Professional Societies that have a lot of useful information about regulatory writing on their websites.

RAPS - Regulatory Affairs Professionals Society. Courses covering numerous regulatory topics can be taken through the online university. Classes can be purchased individually or as part of a certificate program.

AMWA - American Medical Writers Association. Courses can be taken at local chapter events or the annual national meeting. Basic refresher courses can be taken to improve your writing skills. The searchable AMWA magazine and listserv archives are a great place to learn from the experience of people who have successfully made the transition to medical and regulatory writing.

ACRP - Association of Clinical Research Professionals. The annual conference is a great place to meet clinical research professionals.

DIA- Drug information Association. Courses cover many aspects of regulatory affairs.