Medical Writer I is responsible for researching, writing, and editing clinical/statistical reports and study protocols: summarizes data from clinical studies for submission to the Food and Drug Administration (FDA). May require a bachelor’s/master’s degree and 0-2 years of experience in the field or in a related area. Being a Medical Writer I has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Additionally, Medical Writer I works under immediate supervision. Typically reports to a supervisor or manager.
Medical Writer Job Description Template
Our company is looking for a Medical Writer to join our team.
- Write clinical study reports, protocols, clinical development plans, FDA briefing documents, and IND, NDA, and MAA modules;
- Provide input on data analysis planning and interpretation;
- Coordinate quality assurance reviews of documents and maintaining audit trails of changes; and.
- Strong interpersonal skills;
- Capacity to manage time effectively;
- Ability to concisely and accurately communicate scientific information to a variety of audiences;
- Attention to scientific accuracy and stylistic detail;
- Attention to factual detail and accuracy;
- Effective time management, flexibility, and comfort with meeting deadlines;
- Knowledge of AMA style;
- Understanding of AMA style, familiarity with client medical/legal review processes;
- Strong communication skills, both oral and written;
- A life sciences degree, ideally combined with a science Masters or PhD;
- Advanced degree (MS, PhD) in life science, healthcare, or medical/science writing is required;
- Degree in a life science or engineering field (PhD preferred);
- College or advanced degree in a scientific/medical discipline;
- Good working knowledge of standard computer software e.g. Microsoft Office, Adobe, Excel;
- Prior experience in the research, pharmaceutical, or medical device industry preferred.