Medical Writer

Responsibilities

• Drafting and editing high quality, medically accurate documents.
• Submitting articles for publication in peer-reviewed medical journals.
• Working with the Medical Director in preparing and submitting new drug applications to the FDA
• Working within a team, in a collaborative and supportive role, yet taking the lead on key projects as needed. The Medical Writer will provide regulatory documents support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents, and effective implementation of the clinical writing process.
• Salary commensurate with experience.

Qualifications

• An advanced degree in life sciences, medicine, or related fields
• At least 2 years of experience as a medical writer, with well-documented, proven medical writing experience in a pharmaceutical or clinical/contract research organization
• Excellent writing, editing, and communication skills
• Ability to quickly develop an understanding of company SOPs
• Experience in writing IND documents for FDA submission
• Knowledge of medical terminology, research methods, and statistical analysis
• Ability to work independently and collaboratively with different teams
• Familiarity with various document formats, styles, and standards
• Attention to detail and quality
• Creativity and problem-solving skills