6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
In addition to clinical research this advanced medical writing training program trains you to write documents such as medical case reports, clinical trial reports, study protocols, and various other regulatory and medico-marketing documents.
TOTAL CREDITS: 32
Next Start Date
Why study this program?
Medical writing is a rapidly evolving and interesting discipline that comprises of writing subject areas useful for the medical, scientific and healthcare fraternity at large. It also includes writing of documents related to and drug development / clinical research. Two main areas in the pharmaceutical and biotech field where huge demand exists for skilled medical writers are pharmaceutical regulatory writing and medico-marketing writing.
The drug development industry has rapidly progressed in all areas from basic research to bedside research with the scientific and medical writers playing a major role in all phases of product development. Contribution of medical writers is significant in the success or failure of new drugs, therapies and devices.
As per the Center Watch market research analysis conducted in 2008, the medical writing industry has grown at the rate of 15% each year for the last five years to a staggering US $700 million. This rapid growth has been linked to the volume of work outsourced by pharmaceutical and biotech companies in order to meet the applicable regulatory requirements, and to transform clinical trial data into readable documents for scientific and medical publications.
Medical & scientific writers are an essential part of the complete drug & device development process and are responsible for a wide range of activities. Trained medical writers easily find employment in the pharma-biotech and clinical research sector, healthcare companies, press and other print media. They can also provide service as freelance writers.
This Advanced Clinical Research and Medical Writing training program will give you a methodical understanding of the key areas of drug development, clinical research processes, clinical trial management, and medical writing thus boosting your skills and knowledge to the level expected of a clinical research and medical writing professional. In addition to clinical trial management, this Advanced Medical Writing Training Program trains you to write documents such as medical case reports, clinical trial reports, clinical study protocols, and various medico-marketing documents. It opens up opportunities for you both in core clinical research as well as specialist medical writer roles.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 14: MEDICAL DEVICE TRIALS
MODULE 15: PROJECT AND VENDOR MANAGEMENT
MODULE 16: FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17: PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS
MODULE 18: BASICS OF GOOD MEDICAL WRITING
MODULE 19: COMPUTER SKILLS
MODULE 20: OVERVIEW OF THE REGULATORY, MARKETING AND DRUG PROMOTION PROCESSES
MODULE 21: COMMON TECHNICAL DOCUMENT
MODULE 22: PROTOCOL, INVESTIGATOR’s BROCHURE & CASE REPORT FORMS
MODULE 23: CLINICAL STUDY REPORT
MODULE 24: SENTENCE CONTROL
MODULE 25: WRITING FLOW AND COHESIVENESS
MODULE 26: PUBLICATION WRITING
MODULE 27: DOCUMENTS IN MEDICO-MARKETING
MODULE 28: MANAGING THE REVIEW PROCESS
TOTAL CREDITS: 32
MODE OF STUDY: ONLINE
The curriculum for the program - Advanced Post Graduate Diploma in Clinical Research & Medical Writing (APGDCR-MW) is extensive, has been developed and evaluated by experienced industry professionals and is fully endorsed by the clinical research industry. Not only is this program suitable for new graduates but also for working professionals who either wish to grow further in their clinical research and/or medical writing career, or those who wish to make a move to the clinical research or medical writing sector from any other related industry.
How will I be assessed?
You will be assessed on an ongoing basis by the faculty based on the following criteria:
One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
Am I eligible?
The minimum eligibility criteria for Advanced Post-Graduate Diploma in Clinical Research & Medical Writing (APGDCR-MW) 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.
- Students in their final year of graduation for the above courses are also eligible to apply.
Candidates without any science background such as graduates in English language or candidates with some work experience in writing / clinical research / allied areas may also be eligible for this program. Please check with our counsellors for more information.
What support will I receive?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Advanced Post-Graduate Diploma in Clinical Research & Medical Writing Course is provided with a mentor who is an experienced professional from the clinical research industry. The mentor can be contacted at any time via email or phone.
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James Lind Institute offers various masters degree programs in the areas of public health, business administration etc.
- MPH (with specializations)
- M.Sc in Health Mgmt
- MBA (various specializations)
For information on available masters programs via our School of Health Sciences; & our Business School click below:
This combination program of clinical research & medical writing is a unique program that opens up a number of career opportunities in the area of core clinical research as well as medical / scientific writing. Positions that can be explored include Clinical Research Associate, Clinical Research Coordinator, Site Monitor, Clinical Trial Manager etc. As a medical writer you can also 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.
"Medical writing is an excellent career option for people who have a flare for writing. The career is very rewarding. People who demonstrate good people management skills also have an opportunity to grow higher up in the corporate ladder and work in senior positions managing large teams of writers and whole departments."