The Medical Writer is responsible for writing, editing, and reviewing clinical study documents according to global regulatory guidance, templates, style guides and standard operating procedures (SOPs). Clinical study documents may include but are not limited to study protocols and amendments, investigator brochures (IBs), informed consent forms (ICFs), annual safety reports, clinical study reports (CSRs), Integrated Summaries of Safety and Efficacy (ISS/ISE), and other sections of regulatory applications (IND, IDE, NDA, BLA and PMA submissions). Other scientific documents (including but not limited to manuscripts, abstracts, posters) may also be developed.
Specific tasks would include:
- Interpret clinical study results and write, review and/or edit clinical study documents
- Perform quality reviews on documents developed by other writers
- Prepare scientific manuscripts, abstracts, posters
- Review scientific literature, product information and evaluate product data
- Assist with writing and/or reviewing SOPs
- Serve as the primary point of contact for MW on project teams
- Conduct activities within budget and timeline requirements
- Degree in a scientific or medical discipline and 2-4+ years’ experience or equivalent combination of education and experience. Advanced degrees (e.g., PhD, MS, MPH) preferred.
- Familiarity with relevant ICH, GCP, CTD/eCTD and FDA guidances,
- Familiarity with medical terminology
- Excellent proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer and Adobe Acrobat.
- Effective verbal and writing skills; English
This job excludes Colorado applicants.