Writing Careers

Synchrogenix Information Strategies Inc. is always seeking senior clinical regulatory writers for the roles of Principal Writer and Team Lead to work in our offices around the world.

Synchrogenix is a learning-oriented organization with a strong commitment to the idea that every individual--regardless of experience level--has something to teach and something to learn. We provide competitive compensation in a friendly, flexible environment and received a "Best Place to Work" award in Delaware in 2008, 2009, and 2010. For more information, please submit your curriculum vitae (CV) to Stephanie O'Keefe at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Ideal candidates will have previous experience as the lead regulatory writer/author on some, but not all of the following types of documents:

• Investigational new drug applications
• Formulation development reports
• Pharmacokinetic studies
• Investigator's brochures (IBs)
• Phases 1-4 clinical study reports (CSRs)
• Protocols
• Common technical document sections
  • Summary of clinical safety
  • Summary of clinical efficacy
  • Integrated analysis of safety
  • Integrated analysis of efficacy
• Periodic safety update reports

Team Lead 

Senior writers in the role of Team Lead actively participate in development and writing of high-quality documents, consult with clients on strategic messaging and direction, interact with other Team Leads to optimize project success, mentor and coach Synchrogenix writers to achieve greater internal flexibility and job satisfaction, evaluate the performance of Synchrogenix writers within their team to encourage employee engagement, and participate in strategic decision-making affecting corporate activities. 

Principal Writer 

Principal Writers work independently writing a variety of documents including CSRs, protocols, IBs, and clinical summaries. They contribute to document strategy and lead document-writing projects. Principal Writers coordinate the work of other writers as needed. They also provide training of writing staff and ensure compliance with company standard operating procedures (SOPs) and staff training requirements.

Synchrogenix Information Strategies Inc. will also review CVs from experienced bioinformaticians, statisticians, pharmacovigilance staff, clinical pharmacologists, and project managers and coordinators who want to apply their knowledge and experience to the field of regulatory writing.