Principle Medical Writer

Summary:

The Principle Medical Writer is responsible for clinical regulatory documents (e.g., study protocols, Investigator Brochures, Clinical Study Reports, Nonclinical Study Reports, Annual Reports, Regulatory Briefing Documents/Dossiers & Meeting Requests, INDs, and NDAs). Flexibility in work hours/days is essential.

 

Responsibilities:

  • Write clinical protocols, clinical study reports, investigator’s brochures, annual reports, INDs, NDA’s, and BLA’ss and other regulatory documents in conjunction with the project team with minimal supervision
  • Write, review, and/or edit publications (manuscripts, abstracts, poster presentations, etc.)
  • Drive document writing and review processes
  • Develop and maintain timelines for document generation, revision, and completion, with collaboration with other study team members
  • Coordinate and manage review cycles, incorporates team comments, and leads discussions on document revision and finalization
  • May manage outsourced writing projects with minimal supervision
  • Assist in the development and maintenance of SOPs and writing tools, such as templates and style manuals
  • Provide training on medical writing templates, QS Procedures, SOPs, and processes within the department and across departments
  • Contribute to the development of electronic document systems and tools
  • Provide quality control (QC) review of various regulatory and medical communications documents
  • Provide project team(s) with guidance and problem resolution related to document generation
  • Take the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
  • Act as an authoritative resource within specialty area to internal and external resources
  • Work effectively with colleagues from other departments in team situations
  • Ensure writing meets scientific and literary standards and meets objectives
  • Incorporate editorial comments and resolve queries to present a 'finished' final document


 


Requirements:

  • Bachelor’s degree required; advanced life sciences degree preferred, e.g. MS, PhD in a scientific field.
  • Minimum 5 – 8+ years of medical communications writing experience with development of scientific manuscripts and pharmaceutical regulatory documents. 
  • Experience with producing INDs, BLAs, and NDAs in CTD format.
  • Working knowledge of ICH E3, E6, and M4 guidelines and related FDA guidance’s on integrated summaries of safety and of efficacy.