Course - Professional Post Graduate Diploma in Medical Writing

COURSES

Medical writers are an integral part of the drug development process and the health care industry handling a wide range of responsibilities. Professionals with medical writing skills work in the pharma-biotech and clinical research industry, healthcare organizations, media or as freelance entrepreneurs.

JLI students enrolled for the medical writing course get the opportunity of reading, listening to lectures, reference readings, exercises and assignments, as many times as they may need during the course to attain maximum understanding of the subject. This is substantiated by a prompt query resolution support by experienced faculty from the industry. This kind of personalized approach takes away the constraints of distractions, missed classes, fatigue and sometimes-unbearable ennui seen in regular classrooms.

Professional Diploma in Medical Writing

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)

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 medicio-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.

Course Structure

MODULE 1 GENERAL INTRODUCTION
MODULE 2 PHARMACEUTICAL MEDICINE
MODULE 3 BASICS OF GOOD MEDICAL WRITING
MODULE 4 COMPUTER SKILLS
MODULE 5 OVERVIEW OF THE REGULATORY, MARKETING AND DRUG PROMOTION PROCESSES
MODULE 6 CLINICAL STUDY REPORT
MODULE 7 SENTENCE CONTROL
MODULE 8 WRITING FLOW AND COHESIVENESS
MODULE 9 PUBLICATION WRITING
MODULE 10 DOCUMENTS IN MEDICO-MARKETING
MODULE 11 MANAGING THE REVIEW PROCESS

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional and Medical Writer in different capacities.

Course duration

Self Paced 4 to 6 months

A student enrolled in the Professional Diploma in Medical Writing Course is expected to study online for a minimum of fifteen hours per week.

Course Assessment

Course assessment nvolves online MCQs for each lecture, followed by assignments and numerous assessments by tutors in the “Online Campus Tutoring Centre” by the method of interactive discussion.

Eligibility Criteria

The minimum eligibility criteria for the course would include either of the following:

MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.

Fee Structure

Course fee for the Professional Diploma in Medical Writing for 2010-2011 is INR 15,000.
For more details about admissions click here

Academic Support

Each student enrolled in Professional Diploma in Medical Writing course is assigned a mentor throughout the course who will be a senior professional from the Industry. Students are in close contact with the “Student Success Team” during the course and thereafter as alumni. To know more about the “Student Success Team”, click here

In 2008, a Centre Watch market research analysis found that the medical writing market has grown at the rate of 15% annually for the last five years to nearly $700 million. This exponential increase has been attributed to the amount of work outsourced by drug development companies in order to meet the regulatory requirements, and also to convert clinical study data into manuscripts for scientific and medical publications.

Our advanced pedagogical approach provides enrolled students enrolled for the medical writing course with all round professional development. Tutors at JLI form an invaluable resource for the students bringing them in an interface with the industry.