Study location	Online
Type	Advanced PG Diploma, e-learning
Nominal duration	12 months (60 ECTS)
Study language	English
Awards	APGDCR-MW (Advanced Postgraduate Diploma in Clinical Research & Medical Writing)
Accreditation	Certified by Swiss EduQua via certificate no CH20/0771

Tuition fee	€2,200 one-time Payments can be made in full; or 2 equal installments (Half after applying and half within 2 months)

Entry qualification	Bachelor's degree (or equivalent / higher) A bachelor’s degree or equivalent preferably in any life sciences related domain. If you are not sure about your eligibility, please contact our admissions counselors.

Language requirements	English

More information	jliedu.ch

Overview

Mode of Learning: ONLINE
Duration: 12 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week

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.

Programme structure

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
Module 29: Principles of Pharmacovigilance
Module 30: Basics of Clinical Data Management
Module 31: Quality & Quality Management
Module 32: The Quality Assurance Function

Career opportunities

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.