Medical Writer

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.

Responsibilities:

  • 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.

Requirements:

  • 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.