Medical writing is an activity in the production of scientific documentation by a specialized writer. Usually, the scientific researcher is not one of the scientists or physicians who did the research. A medical writer, collaborating with doctors, scientists and other subject matter experts, creates papers that accurately and accurately explain research results, product use and other medical information. The medical writer also ensures that the papers comply with statutory, journal or other standards in terms of design, format and structure. Medical writing as a tool has become known in the pharmaceutical world because the industry has understood that it requires special skills to create well-structured documents that present the information clearly and concisely. Increasing numbers of new drugs are undergoing an increasingly complex process of clinical trials and regulatory procedures leading to market approval. This drives the demand of well-written, standard-compliant documents that science professionals can quickly and easily read and understand.
Work Profile
Job Description
Accountable for timely preparation, manufacturing and quality control of regulatory documents, including coordination with regulatory project teams, creation of editorial timelines and workflow specifications, scheduling and tracking of documents, assessment of documentation staffing needs, participation in the “roundtable” review of documents, development of project-specific style guidelines, editing in a variety of ways. Develops and updates the design requirements, the format of the production elements, the tracking of regulatory documents and the artwork used in regulatory documents. Hires, trains and supervises editorial seasons and coordinates their work. Develop and update departmental editorial style standards by preparing and revising a style guide. Provides guidance on writing to authors of regulatory submissions and develops and updates basic guidelines for writing by planning and revising the author’s guide.