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Medical Writing

Medical writing is the activity of producing scientific documentation by a specialized writer — documents that effectively and clearly describe research results, product use and other medical information.

RegulatoryDocuments & submissions

JournalsPublication guidelines

Style guidesEditorial standards

QCQuality control & review

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What is medical writing?

Clear, compliant scientific documents

The medical writer typically is not one of the scientists or doctors who performed the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure.

ClearInformation presented clearly and concisely.

CompliantRegulatory, journal and other guidelines.

CollaborativeWorking with doctors, scientists and experts.

In demandMore new drugs need standards-compliant documents.

Why demand is growing. Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.

Work profile

Medical Writer / Content Writer / Medical Data Reviewer

Responsible for the timely preparation, production and quality control of regulatory documents.

01

Plan & coordinate

Responsible for the timely preparation, production and quality control of regulatory documents.
Coordinates with regulatory project teams, creates editorial timelines and work flow specifications, and schedules and tracks documents.
Assesses documentation staffing needs.

02

Write & edit

Writing and proofreading, and editing at various levels.
Participates in “round-table” review of documents.
Establishes project-specific style guidelines.

03

Specifications & standards

Develops and updates specifications for the design, format production elements, tracking of regulatory documents and artwork used in regulatory documents.
Develops and updates departmental editorial style standards by preparing and revising a style guide.

04

Guide the team

Hires, trains and supervises editorial temporaries and coordinates their work.
Provides guidance on writing to authors of regulatory submissions, and develops and updates general writing guidelines by preparing and revising an author’s guide.

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