Senior Medical Writer

Responsibilities

The Senior Medical Writer is responsible for crafting and editing clinical and scientific documents, including statistical analysis summaries, literature reviews, abstracts, and posters, for regulatory submissions or sponsor use. Key duties include:

• Collaborating with sponsors and/or internal medical personnel and statisticians to develop clinical development plans, study protocols, and clinical study reports.
• Designing templates and shells for integrated clinical study reports in alignment with ICH guidelines, sponsor standards, and study protocols.
• Leading review meetings to address feedback from the team and/or the sponsor.
• Writing journal articles, abstracts, and posters in collaboration with statisticians and/or sponsors.
• Preparing clinical sections for INDs, NDAs, and other regulatory submissions.
• Drafting investigator brochures and annual reports, as well as briefing documents for regulatory submissions.
• Ensuring consistency in style, format, and content across all IND and NDA documents within a project.
• Performing additional duties as assigned.
  
  

Education

• Bachelor’s degree in a scientific discipline is required.
• Graduate degree is preferred.
  
  

Experience

• At least 10 years of medical writing experience, with a minimum of 5 years specializing in regulatory writing within the biotechnology or pharmaceutical industry.
  
  

Skills

• Proficiency in ICH guidelines, particularly for Investigator Brochures, Clinical Study Reports, INDs, and NDAs, with experience in writing at least one NDA or BLA.
• Familiarity with electronic document platforms is preferred.
• Additional experience in drug development areas such as clinical trial monitoring, data management, or statistics is advantageous.