Diploma in Medical Writing

(2 customer reviews)

$499.00

Self-paced online training in scientific, clinical, regulatory and publication writing.

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Description

The Diploma in Medical Writing is a comprehensive online eLearning program designed to develop knowledge and practical understanding of scientific, clinical and regulatory medical writing.

The program introduces the principles of clear and effective scientific writing before progressing to literature research, regulatory documentation, clinical study protocols, Investigator’s Brochures, Case Report Forms and Clinical Study Reports.

Learners also explore the Common Technical Document (CTD/eCTD), publication writing, abstracts, posters, case reports, scientific manuscripts, publication guidelines and referencing.

The curriculum further introduces medico-marketing communications and the document review process, helping learners understand how scientific and medical information is structured, reviewed and communicated for different audiences.

The program is delivered through flexible, self-paced eLearning with multimedia tutorials, recorded learning content, quizzes and assessments.

Program at a Glance

14 Modules | 85 Chapters | 86 Quizzes

3 Months | Self-Paced eLearning | Certificate on Completion

What You’ll Learn

  • Understand the principles of clear and effective scientific writing
  • Develop knowledge of different types of medical writing
  • Conduct literature searches for scientific and medical information
  • Understand regulatory medical writing and regulatory documentation
  • Explore the structure of CTD and eCTD submissions
  • Understand the purpose and structure of clinical study protocols
  • Explore Investigator’s Brochures and Case Report Forms
  • Understand Clinical Study Report preparation
  • Develop knowledge of patient narratives and safety-related documentation
  • Understand effective sentence construction, readability and writing flow
  • Explore scientific manuscripts, abstracts, posters and case reports
  • Understand publication guidelines and publication ethics
  • Develop familiarity with referencing and reference-management approaches
  • Explore medico-marketing and scientific communication documents
  • Understand document review and approval processes

Who Is This Program For?

  • Students and graduates interested in medical and scientific writing
  • Pharmacy, medicine, life sciences and healthcare graduates
  • Clinical research professionals involved in clinical documentation
  • Regulatory Affairs professionals working with scientific and regulatory documents
  • Pharmacovigilance professionals involved in safety documentation
  • Researchers interested in scientific and publication writing
  • Professionals seeking structured learning in clinical and regulatory medical writing

Types of Medical Writing Covered

Scientific Writing

Learn principles of scientific communication, sentence construction, writing flow, data presentation and clear presentation of technical information.

Clinical & Regulatory Writing

Explore protocols, Investigator’s Brochures, Case Report Forms, Clinical Study Reports, regulatory submissions and other clinical-development documents.

Publication Writing

Develop knowledge of scientific manuscripts, abstracts, posters, case reports, reviews, publication guidelines and publication ethics.

Medico-Marketing & Scientific Communications

Explore scientific communication materials used to present medical and healthcare information to professional audiences.

Develop Medical Writing Through Structured Practice

Medical writing requires more than understanding document formats. The program introduces writing principles and provides opportunities to apply them across scientific, clinical, regulatory and communication-focused writing activities.

Learners explore how medical information is organized for different document types and audiences while developing familiarity with the writing and review processes used for scientific and clinical documentation.

Learn More About Medical Writing

New to the field? Explore our introductory resource to understand the role of medical writers and the different types of scientific, clinical and regulatory documents they work with.

What is Medical Writing?

 

Key Features

  • Comprehensive Medical Writing curriculum
  • Scientific, clinical and regulatory writing
  • Clinical study and regulatory document training
  • CTD/eCTD concepts
  • Publication and scientific communication writing
  • Medico-marketing communication topics
  • Flexible self-paced multimedia learning and assessments
  • ClinSkill Certificate of Completion

Curriculum

Module 1 – General Introduction
  • Pharmaceutical & CR – Industry Overview
  • Introduction to Clinical Research
  • Stakeholders and Roles in Clinical Research
  • History and Milestones in Clinical Research
  • Principles of Good Clinical Practice
  • Technologies in Clinical Trial Management
  • Overview of Clinical Research Regulatory Bodies
Module 2 – Epedemiology and Evidence Based Medicine (EBM)
  • Epidemiology 1 – Introduction
  • Epidemiology 2 – Concept of Causation
  • Epidemiology 3 – Epedemiological Study Designs
  • Epidemiology 4 – Statistics
  • Evidence Based Medicine
Module 3 – Pharmaceutical Medicine
  • Introduction to Pharmaceutical Medicine
  • Pre-clinical Development of Drugs and Biologics
  • Clinical Phases of Drug development
  • General Pharmacology
  • BA-BE Studies
  • Pharmacogenetics-Pharmacogenomics
  • Toxicology
  • Systemic Pharmacology
  • Clinical Trial Design
  • Intellectual Property Rights
  • Personalized Medicine
  • Clinical Trials in Pediatrics
  • Drug Safety in Pregnancy
  • Research Methods for Genetics Studies
  • Stem Cell Research and its Applications
  • Endpoints in Clinical Trials
  • Clinical Trial Registries
Module 4 – Basics of Good Medical Writing
  • Introduction & Scope of Medical Writing
  • Good Versus Poor Scientific Writing – An Orientation
  • Statistics in Medical Writing
Module 5 – Computer Skills
  • MS Word, Excel & Other Open Source Software
  • Effective Internet Literature Search
Module 6 – Overview of the Regulatory, Marketing and Drug Promotion Process
  • Introduction to Regulatory Medical Writing
  • Investigation New Drug & Investigational Device Exemption Application
  • Protocols, Amendments & Study Reports
  • Investigator Brochure & Product Labels
  • NDA’s, BLA’s & PMA’s
  • Annual Reports
  • Product Labeling
  • Abstracts & Posters for Scientific Meetings
  • Manuscripts for Publication in Scientific Journals
  • Legal-Copyright-IP Issues in Medical writing
Module 7 – Common Technical Document
  • Introduction and overview of CTD and eCTD
  • Putting it all together – CTD Module 1
  • Putting it all together – Producing the CTD Modules
  • Multi-region submissions & submission standards
  • Interfacing with regulatory agencies and answering queries
  • Aggregate safety reports
Module 8 – Protocol, Investigator’s Brochure and Case Report Forms
  • Writing clinical study protocols
  • Introduction to writing Investigator Brochure’s
  • Writing case report forms
  • Writing regulatory compliant informed consent forms
  • ICSR – Patient Narratives
Module 9 – Clinical Study Report
  • Parts of a Clinical Study Report
  • Templates & Boilerplate Text
  • Tips on writing each section of the CSR
Module 10 – Sentence Control
  • Fundamentals of Sentence Construction
  • Controlling Voice of Sentence for Readability
  • Correct Punctuation
  • Consistency in Tense Use
  • Imprecise Words and Phrases
  • Word Order and Pronouns
  • Subject – Verb Agreement
Module 11 – Writing Flow and Cohesiveness
  • Writing Effective Paragraphs
  • Using Effective Data Displays
  • Using Style Guides for Consistent Medical Writing
  • Overcoming Writers Block
Module 12 – Publication Writing
  • Structure of a Scientific Paper
  • Electronic Submissions
  • Abstract for Scientific Meeting
  • Case Report
  • Review
  • Ethics of Publication
  • Guidelines of Publication (e.g. CONSORT, ICMJE, GPP)
  • Referencing Guidelines & Taking Software’s Help
Module 13 – Documents in Medico-Marketing
  • Leave behind literature (LBL), Visual Aids and Brochure’s
  • Continuing Medical Education (CME) for Doctors
  • Evidence Based Medicine
  • MR Training Manual
  • Web Content, Audio-Visual Aids, CDs
Module 14 – Managing the Review Process
  • Effective Review Practices
  • Managing Incongruous Comments from Reviewers & Reaching Concurrence
  • Process Flow and Metrics for Managing Regulatory Submissions
Course Completion
  • Final Assessment
  • Course Certification

Certification

Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.

Duration

The program duration is 3 months, with flexible, self-paced access to the online learning portal for the duration of the program.

2 reviews for Diploma in Medical Writing

  1. John ONeill (verified owner) –

    I learned a tremendous amount from this certificate and will probably do more CLINSKILL training. Nitin in customer support was terrific. I give it four stars instead of five because some (a small minority) of the lessons weren’t as good as the majority. Even so, I’d recommend it to anyone else who’s interested. John O’Neill

  2. Tahir Bhasin –

    Detailed program that covered all the aspects of Medical Writing as applies to the pharmaceutical industry.

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