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Regulatory Medical Writer

Medical & Scientific Writing

Regulatory Medical Writer

Medical writing involves writing different documents of different types for varied audiences. Medical writers write scientific documents for the purpose of regulatory submission, research-related documents relating to drugs, disease and the clinical trials for the healthcare professionals. Documents are also written for the understanding of the general public in simple language through drug safety manuals, publications of news article relating to drugs, health related magazines and also content for healthcare websites  (Medical Journalism).

There are different types of medical writing meant for a diverse set of audience, e.g. medical professionals, patients & general public, medical sales representatives or drug regulators.

Examples of different kinds of medical writing:

  • Medical Journalism: Articles that are published in newspaper and magazines for the understanding of general public and layman which is in simple and non technical language
  • Medical Education: Medical writings for physician’s textbook, e-learning modules, patient’s education materials.
  • Medical marketing of healthcare products: Promotional literature for the healthcare professionals, product monographs, brochures, handouts, Sales force training manuals.
  • Publication/Presentation: publication of articles for medical Journals, Abstracts, presentations for conferences, letter to editor and review articles.
  • Research Documents: Clinical trial protocols, Investigators′ Brochure, Informed Consent Documents, Study reports, Research proposals
  • Regulatory Documents: Quality control of the submission document involved, documents that are Package Inserts ,new drug application, Clinical study reports, Subject narratives.
  • The nature of work of The Regulatory Medical Writer is to produce a wide range of clinical documents throughout the life-cycle of drug development/treatments starting with describing and reporting data from clinical trials, presenting the information gathered through clinical trials and  preparing regulatory submission documents to the regulatory authorities and ethics committees.

Regulatory Medical Writers combine their knowledge of science and their research understanding to present information, as well as have the ability to summarize the statistical findings. Regulatory medical writers provide the highest quality scientific documents to satisfy the needs of the targeted audience

A good Regulatory Medical Writer is involved in a broad spectrum of tasks. Regulatory medical writers are trained to meet the latest global regulatory requirements, review other documents of clinical research process i.e. statistical analysis plans [SAPs]), Risk Evaluation and Mitigation Strategy (REMS) documentation, Good Clinical Practice (GCP) guidelines summaries highly complex data. They are familiar with International Conference on Harmonization (ICH) guidelines, regulatory style requirements.

Regulatory Medical writers have a degree in science such as biology, biochemistry, physiology, pharmacy or a PhD in a life science, science related or medical subject and may be freelance, or employed by sponsors (e.g., pharmaceutical/biotech companies) or clinical research organisations (CROs), although it is not mandatory to have a medical background.

The ever demand for medical writing is growing steadily in pharmaceutical and healthcare communication industry. Medical writers can work independently or be employed as full time professionals. Medical writers can be employed by pharmaceutical and biotechnology companies, clinical research organizations (CROs), health regulatory authorities, communications agencies, healthcare journals and websites etc. Life sciences graduates can consider medical writing as a valuable career option.

JAMES LIND INSTITUTE offers online courses in this field of Medical Regulatory Writing which students can choose as per their interest. Follow the below link for details.

Advanced PG Diploma in Clinical Research & Medical Writing

Advanced PG Diploma in Pharmacovigilance & Medical Writing

Advanced PG Diploma in Pharmacovigilance & Medical Writing

Advanced PG Diploma in Scientific Writing & Medical Journalism

Professional Diploma in Medical Writing

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