Senior Medical Writer

Responsibilities:

  • Prepare, write and edit complex clinical documents that present clinical data objectively and in a clear, concise format.
  • This includes, but may not be limited to: protocols and amendments, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Documents, briefing books, Common Technical Document (CTD) modules such as nonclinical and clinical overviews, annual safety reports, etc.
  • Write and edit nonclinical and clinical manuscripts for submission to peer-reviewed journals.
  • Prepare and edit abstracts, posters, and PowerPoint presentations for scientific meetings.

Requirements:

  • Demonstrated experience writing, editing, and formatting documents having scientific/medical content and requiring knowledge of Food and Drug Administration (FDA) guidelines pertaining to the specific types of documents.
  • Experience in writing clinical protocols and amendments, CSRs, IBs, briefing books, and regulatory submission documents.
  • Experience with IND and NDA submissions.
  • Track record of scientific publication (i.e., research articles in peer-reviewed journals).
  • Solid understanding of drug development process, pharmacology, clinical research, study design, drug safety, biostatistics and regulatory.
  • Detail oriented with excellent interpersonal and communication skills.
  • Ability to work in a fast faced business environment and meet tight deadlines.
  • Minimum 8 years’ experience as a scientific/medical writer in pharmaceutical industry and/or Contract Research Organizations (CROs).
  • Proficiency in the use of PowerPoint, Microsoft Word, Microsoft Excel and other relevant editing software.
  • Knowledge of technical guidelines a “must”.
  • BS or MS in Life Science preferred.
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