Sr. / Principal Medical Writer (regulatory Focus) - Sponsor-dedicated; Us/can

Syneos Health

United States
$80,600.00 - $145,000.00 py
On-site
Regulatory medical writing experience
Clinical study protocols and amendments
Clinical study reports (csrs)
Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately

Job Summary

  • Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
  • Completes a variety of documents that may include clinical study protocols, clinical study reports, IND submissions, and NDA submissions.
  • Adheres to established regulatory standards, including ICH E3 guidelines, as well as company standard operating procedures and client standards.

Matching Summary

Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.

Salary

$80,600.00 - $145,000.00

Skills & Requirements

Must-have

  • Regulatory medical writing experience
  • Clinical study protocols and amendments
  • Clinical study reports (CSRs)
  • Investigator brochures (IBs)
  • IND and NDA submissions
  • ICH E3 guidelines adherence
  • Client interaction and management

Nice-to-have

  • Agile and driven team environment
  • Passionate problem solvers
  • Career development and progression
  • Total Self culture
  • Diversity of thoughts and backgrounds

Key Requirements

  • Minimum of 5 years lead regulatory writing experience
  • Experience with Phase 2 and 3
  • Lead writer experience with CTD Modules 2.7.3 and 2.7.4
  • Strong project management skills
  • Strong client experience
  • Time management skills

Work Rights

Not specified

Tailored Resume

Cover Letter