Writes and prepares documents for clinical/regulatory submissions (CSRs, protocols, IBs, and annual reports)

Develops templates/guidelines for clinical/regulatory documents (CTDs/NDAs, protocols, CSRs, IBs, annual reports)

Critically reviews documents

Assists the publication planning committee and investigators in development/review of abstracts, manuscripts and poster/slide presentations

Supports corporate development including sales/marketing

Provides oversight for medical writing projects according to standards and SOPs

Reviews, organizes, interprets, and summarizes clinical data in an organized and accurate manner

Responsible for document development

Manages projects, tasks and oversees their completion within established schedules and timelines

Recruits, mentors, and trains medical writers

Mentors other members of the clinical project team that  contributes to report preparation of clinical/regulatory documents

Represents medical writing group at meetings

Prepares time/cost estimates for medical writing projects

Ensures documents are written in compliance with ICH/FDA-CFR guidelines and company SOPs

BS degree with advanced degree preferred with science degree REQUIRED

Minimum 4 management experience in industry REQUIRED

Minimum of 4 years writing experience within regulatory documentation

Ability to resolve problems, address complex issues on a cross-functional level and make policy decisions is essential

Ability to meet aggressive deadlines and maintain high quality deliverables

Excellent oral and written communication

Proficient computer skills including Microsoft Office

Project management experience a plus

Research experience (including compilation of research reports or publications) in industry or as a  postgraduate program a plus

Working knowledge of experimental design, biostatistics and knowledge of standard editorial style a plus