- 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.
- 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.