Clinical Regulatory Medical Writer

Regulatory Medical Writer needed in Bethesda, Maryland
The selected candidate will participate as a member of clinical team and serves as team specialist in matters pertaining to clinical documentation.
With guidance from other team members (Clinical Research, Biostatistics, Regulatory Affairs, Drug Safety), the Medical Writer researches, writes and edits manuscripts, study protocols, Investigator?s Brochures, clinical study reports, summarizing data from clinical studies for submission to the FDA and for publication and/or presentation.
Assists in the development of formats and guidelines for clinical documentation and leads the documentation process, ensuring compliance to FDA reporting requirements including quality, resource requirements, scheduling and scientific standards
Resolves errors and inconsistencies in clinical data with Biostatistician and other project members
May also support CRAs and MDs in clinical protocol development REQUIREMENTSB.S. or M.S. in scientific discipline, 5 years' experience with a B.S. or 3 years'experience with a M.S.
Candidate must have 3-5 years experience in regulatory medical writing for a pharmaceutical, biotechnology or contract research company/university medical center, and an understanding of clinical regulatory documentation requirements. This experience must include IND/NDA submissions.
Proficiency with Microsoft Office applications
Must be able to research and review clinical content effectively and translate information into clear and concise messages using a high quality scientific writing style in the English language
Capable of critically analyzing data from a broad range of disciplines
Ability to successfully manage multiple projects from conception to completion, working in a team environment
Must have excellent writing and editing skills

Keywords: Medical Writer, pharmaceutical, clinical trials, FDA, clinical research, MedFocus