Clinical Development Sciences

PROGRAM DURATION

4 - 6 Months (Self Paced)
Maximum Allowed Duration: 18 Months
Expected Effort: 10-15 hours/week

Professional Diploma in Medical Writing

This online medical writing training program provides you with a thorough understanding of both pharmaceutical regulatory writing as well as medico-marketing writing thus boosting your skills as a medical and scientific writer.

TOTAL CREDITS: 18

Next Commencement Date

01 SEP

2019

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INTRODUCTION

Why study this program?


Introduction

Medical and scientific writing is a specialized and exciting discipline. It involves writing documents helpful for the medical fraternity and the drug development industry. Two major sectors in the pharmaceutical and biotech industry with an increasing demand for medical writers are regulatory writing and marketing material writing. (Medico-marketing writing)

Medical Writing Training

There is an increasing need in the pharmaceutical and biotech industry for medical writing professionals. Medical writing specialists develop documents in a standard and well written fashion, compliant to regulatory standards for approval of drugs, devices and biologics.

Medical writing profession dominates the pharmaceutical and biotech industry by preparing the most critical and crucial documents for regulatory approvals. A few of the documents prepared by medical writers in the pharmaceutical/clinical research industry are clinical study reports (CSR), periodic safety update reports (PSUR), investigator brochures (IB), summary of product characteristics (SmPC), patient information leaflets (PIL), etc. On this regulatory end of the medical writing spectrum, medical writers work on all the documents related to submission for approvals.

The other end of the medical writing profession is towards the marketing of pharmaceutical and biotech products and public awareness related to healthcare. Medical and scientific writing inhere involves a number of activities as shown in the figure. In case of medico-marketing writing the audience ranges from highly qualified physicians to scientific writing material for the general public.

The confluence of the two ends of the spectrum is where scientific manuscripts are prepared, and where publications undergo a systematic review to produce the best of evidence related to health care and scientific discovery.

Regulatory medical writers with a complete understanding of the clinical research processes expedite the traverse of a drug candidate over the path to physicians desk. Medical and scientific writing professionals working at the health care end of the spectrum form an important element in the communication channel sending information back to the laboratory for efficient translational research to take foundation.

In the wider clinical research industry, a large number of clinical research management organizations have recently developed which includes a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management and drug safety, clinical research consultancies, KPOs, etc. This has created a demand for skilled workforce in the clinical research industry as stressed in many business reports.
James Lind Institute is committed to developing emerging professionals for the clinical research industry who are equipped with the most relevant and latest knowledge and expertise.
The Professional Diploma in Medical Writing will provide you with a methodical understanding of the core areas of medical writing thus enhancing your skills and knowledge to the level expected of a Medical and Scientific Writer. It imparts rigorous medical writing training to develop professional expertise of high caliber.
The Professional Diploma in Medical Writing course curriculum is fully reviewed and endorsed by the Clinical Research Industry and the academia thus imparting students the edge that they require to make an entrance in the industry. This course also empowers the professionals working in the clinical research industry with the advanced skills training and knowledge required to move to higher cadres of the management hierarchy.

PROGRAM STRUCTURE

What will be taught?


Program Structure

MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY AND EBM
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: BASICS OF GOOD MEDICAL WRITING
MODULE 05: COMPUTER SKILLS
MODULE 06: OVERVIEW OF THE REGULATORY, MARKETING AND DRUG PROMOTION PROCESSES
MODULE 07: COMMON TECHNICAL DOCUMENT
MODULE 08: PROTOCOL, INVESTIGATOR’s BROCHURE & CASE REPORT FORMS
MODULE 09: CLINICAL STUDY REPORT
MODULE 10: SENTENCE CONTROL
MODULE 11: WRITING FLOW AND COHESIVENESS
MODULE 12: PUBLICATION WRITING
MODULE 13: DOCUMENTS IN MEDICO-MARKETING
MODULE 14: MANAGING THE REVIEW PROCESS

TOTAL CREDITS: 18

MODE OF STUDY: ONLINE

The curriculum for the program - Professional Diploma in Medical Writing (PDMW) is extensive, has been developed and evaluated by experienced medical writing professionals and is fully endorsed by the industry. This training program is suitable both for new graduates and for working professionals who either wish to grow further in their medical writing career, or those who wish to make a move to medical / scientific writing from any other related sector.

ASSESSMENT

How will I be assessed?


Assessment

Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.


Overall academic performance in the program is measured on a 4 point Cumulative Grade Point Average (CGPA) scale. More information about this is available here: Evaluation System

ELIGIBILITY

Am I eligible?


Eligibility

The minimum eligibility criteria for Professional Diploma in Medical Writing (PDMW) would include either of the following:

- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health
- Any degree in English Language
- Students in their final year of graduation for the above courses are also eligible to apply.

If you lack the above mentioned educational prerequisite you may still be eligible to apply if you have some prior work experience in medical or scientific writing. Please contact our admission representatives / counsellor to discuss your case.

ACADEMIC SUPPORT

What support will I receive?


Academic Support

Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.


Each student enrolled in the Professional Diploma in Medical Writing Course (PDMW) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.

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Program Fee

How much will it cost?
Please use our online fee calculator to calculate the fee applicable to you.



CAREER OPPORTUNITIES

Having formal training in medical writing opens up a number of career opportunities in the area of medical / scientific writing. As a medical writer you can explore multiple career opportunities with pharmaceutical companies, contract research organizations, medical communications companies, healthcare websites, journals, magazines etc. In addition to working as a full time writer you can also explore freelance medical writing opportunities.


MORE INSIGHT

In 2008, a Centre Watch market research analysis reported that the medical / scientific writing market has grown at the rate of 15% every year for the past half decade close to $700 million. This rapid growth has been reported to be due to the sheer volume of work outsourced by pharmaceutical and other companies in order to create regulatory documents, and also to convert clinical trial data into publication formats for various international medical publications.


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