Medical Writer Job in Ellicott City, Maryland Us
The successful candidate will review and interpret clinical data, independently write, edit, compile and QC documents, ensure the accuracy and quality of applicable written deliverables, and ensure compliance with ethical, legal, scientific, regulatory and client standards, in the Ellicott, MD location.
Role Responsibility
- Review for quality and assist in the interpreting, analyzing and presenting data from clinical studies, including tables, figures and listings
- Write, review, edit and QC documents for clients including synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, manuscripts, clinical development plans and analysis plans, that meet scientific and regulatory standards as applicable
- Writing regulatory submissions and/or relevant sections.
- Ensure proper version control of all applicable documents
- Assist in preparing scientific, process and capability presentations for prospective clients (Business Development, Bid Defense) and for presenting at conferences and professional meetings
- Resolve issues and escalate problems as necessary
Experience Qualification
- BS/BA (or local equivalent), preferably in a biomedical science plus additional medical and/or relevant scientific education.
- Advanced degree (Masters, PhD, or local equivalent) a strong plus.
- A minimum of two years of relevant (phase 1 to 2a) experience in medical writing/editing, clinical drug development, clinical research and regulatory science
- Knowledge of scientific and regulatory requirements applicable to early phase clinical studies, study protocols and reports
- Excellent written and verbal communication skills, clinical data-interpretation skills, strong interpersonal and leadership skills, ability to plan/organize and multi-task.
- Excellent computer skills to include MS Word, Excel, PowerPoint, Visio; scientific graphing (e.g. SigmaPlot, Origin, Prism, Patient Profiles) a plus
- Document organization, management and version control skills to include hyper-linking, TOC generation.
