Medical Writer Job Description
Duties and Responsibilities
To accomplish their primary goal of communicating complex medical information in clear and compliant writing, Medical Writers perform many tasks.
Able to work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Able to assess data or products using their medical expertise, and quickly develop expertise in new areas as needed for their writing.
Responsible to conduct comprehensive literature searches to enhance their background understanding, and evaluate and analyze the information they will be writing about.
Medical Writers compile, write, and edit medical writing deliverables covering all phases of clinical research for submission to regulatory agencies. Medical Writers help write studies for submissions to the EMI, ECs, FDA, etc. Their writing is also used in publications or medical journals, or for internal company use. Examples: clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Communicate to scientific liaisons, healthcare professionals, and pharmaceutical representatives. They prepare abstracts, scientific exhibits, posters and verbal presentations.
Develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Be sure that all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents that the Medical Writer prepares must meet ICH, GLPs, and GCPs guidelines, a writing style guide, and often a company or client template. The Medical Writer must understand the levels of evidence required to achieve regulatory, marketing and regulatory goals.
Medical Writer Skills
A strong communicator with meticulous attention to detail, a successful Medical Writer has solid writing and organizational skills. They are curious and motivated, and work well independently or as part of a team in high-pressure situations. In addition to these general skills and personality traits, employers are seeking Medical Writer candidates with the following skills.
Core skills: Based on job listings we looked at, employers want Medical Writers with these core skills. If you want to work as a Medical Writer, focus on the following.
- Extensive knowledge of English grammar with a familiarity with a standard style guide
- Ability to communicate scientific or medical information in a clear and concise manner
- Proficiency in Word, Excel, PowerPoint, email, and the Internet
- Familiarity with the principles of clinical research
- Ability to interpret and present clinical data and other complex information
- Experience in a Medical specialty (i.e. oncology or medical devices)
- Thorough understanding of FDA and ICH regulations and guideline
Please email your resume to [email protected]