Career Options for Pharm.D in Medical Writing : An Indian perspective

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Today, I would like to discuss about the importance of Medical writing and career options in Medical writing.

* Any graduate in Pharmacy is eligible to apply, mostly preference will be given for MBBS, MD, BDS graduates and now even for PharmD.

Medical writing is the activity of producing scientific documentation by a specialized writer with special skills to produce well-structured documents that present information clearly and concisely.

1. Creates documents that effectively and clearly describe research results, product use and other medical information.
2. The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure.
3. The drive for complex process of clinical trials leads to a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.
4. Responsible for the timely preparation, production and quality control of regulatory documents, including coordinating with regulatory project teams, creating editorial timelines and workflow specifications, scheduling and tracking documents.
5. Assess documentation staffing needs, participates in “round-table” review of documents, establishing project-specific style guidelines, editing at various levels, writing and proofreading.
6. Develops and updates specifications for the design, format production elements, tracking of regulatory documents and artwork used in regulatory documents.
7. Hires, trains and supervises editorial temporaries and coordinates their work. Develops and updates departmental editorial style standards by preparing and revising a style guide.
8. Provides guidance on writing to authors of regulatory submissions, and develops and updates general writing guidelines by preparing and revising an author’s guide.

Types 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:

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

Medical marketing of healthcare products:

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

Publication/Presentation:

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

Research Documents:

1. Clinical trial protocols
2. Investigator's′ Brochure
3. Informed Consent Documents
4. Study reports
5. Research proposals

Regulatory Documents:

1. Package Inserts (prescribing information)
2. Patient Information Leaflets
3. Clinical study reports, web synopses
4. Subject narratives
5. Regulatory submission documents – Common Technical Document (CTD) modules such as nonclinical and clinical overviews and summaries
6. Expert reports
7. Safety and efficacy summaries.
8. Aggregate safety reports such as Periodic Safety Update Reports ( PSURs), bridging reports.
9. Periodic Adverse Drug Experience Reports (PADER)
10. Annual safety reports (ASR)s and policy papers.

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Happy Blogging...!!!

Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia