Certificate Course in Medical Writing

Step-by-step practical learning on different writing methods and types of documentation according to the national and international ethics and guidelines

  • Total Hours: 200 hrs; 75 hours of learning content plus 125 hours of assignments
  • Learn from established industry experts with 15+ yrs of experience

Course Description

In the last few years, the demand for medical writing has risen considerably. There are many reasons for this–more study studies are currently being undertaken in the biomedical sector; pharmaceutical businesses are developing more new medicines and medical devices and numerous science papers need to be produced for submission to regulatory authorities during their approval phase; the amount of biomedical publications has increased significantly and many more science papers are now being produced.

The medical writing industry has increased in size over the past five years, from an estimated $345 million in 2003 to $694 million in 2008, according to the CenterWatch assessment. In addition, medical writing is also the fourth most frequently outsourced service according to a distinct survey.  As pharmaceutical companies outsource more and more job to Asia, Indian graduates can look at medical writing as a precious career choice and acquire the expertise and abilities needed to take it up as a full-time job.

  • Course Content
  • What Will You Learn?
  • Who Can Learn?

Medical writing involves writing different types of documents for different purposes, and for different audiences. Following are examples of different kinds of medical writing:

Medical Journalism

  • Newspaper & magazine articles. These are mostly for general public and lay people and need to be written in simple, non-technical language.

Medical Education

  • For Physicians – textbooks, Continued Medical Education (CME) programs, slide decks, e-learning modules
  • For Patients – patient education material

Medical marketing of healthcare products

  • Promotional literature targeted at healthcare professionals, product monographs, brochures, handouts
  • Sales force training manuals, e-learning modules
  • Internet content for physicians and patients (consumers)

Publication/Presentation

  • Journal articles / manuscripts (research articles, case reports, review articles)
  • Abstracts
  • Posters & presentations for scientific meetings and conferences

Research Documents

  • Clinical trial protocols
  • Investigators′ Brochure
  • Informed Consent Documents
  • Study reports
  • Research proposals

Regulatory Documents

  • Package Inserts (prescribing information) & Patient Information Leaflets
  • Clinical study reports, web synopses
  • Subject narratives
  • Regulatory submission documents – Common Technical Document (CTD) modules such as nonclinical and clinical overviews & summaries, expert reports, safety & efficacy summaries; Aggregate safety reports such as Periodic Safety Update Reports ( PSURs), bridging reports, Periodic Adverse Drug Experience Reports (PADER), Annual safety reports (ASR)s; policy papers etc.

The Certificate Course in Medical Writing from Clinosol Research Pvt. Ltd. has been designed in a way to provide the student with the insights required to start a career in Medical Writing.

    • Ability to understand the purpose and requirements of the project
    • Ability to write at a level appropriate to the target audience
    • Thorough research of the subject
    • Ability to think, logical organization of thoughts and ideas
    • Scientific accuracy
    • Attention to details
    • Ability to work across teams (often remotely) as well as independently
    • Good communication & coordination with various people involved in the process
    • Good time management, and meeting deadlines and commitments

THE BASICS

  • Literature / reference searching
  • Interpretation and presentation of research data
  • Considering ethical & legal issues while writing

 

ADVANCED LEVEL

  • Understanding the project brief
  • Literature search & review of information
  • Authoring & compiling the documents
  • The review process
  • Formatting & editing
  • Approval and sign off
  • Electronic publishing
  • Graduates and postgraduates from pharmacy and life sciences,
  • MBBS
  • BDS
  • BHMS
  • BAMS
  • Pharm. D

Other Course Options: This course can be taken in combination with other courses like Regulatory Affairs & Clinical Research

On successfully completing all the learning modules, you will be awarded the,
Certificate in Medical Writing/Clinical Research and Medical Writing/Regulatory Affairs and Medical Writing’ certification.

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