Principle Medical Writer
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.
- 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
- 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.