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

SyneosHealth

United States
Base: $80,600.00 - $145,000.00; bonus/equity: elig...
Fully remote
5 years lead regulatory writing experience
Phase 2 and 3 clinical trial experience
Protocol and submission document authoring
The role involves leading the clear and accurate completion of medical writing deliverables for regulatory submissions including NDAs and eCTDs

Job Summary

  • The role involves leading the clear and accurate completion of medical writing deliverables for regulatory submissions including NDAs and eCTDs.
  • Candidates must possess deep expertise in regulatory requirements and guidelines affecting medical writing across Phase 2 and 3 studies.
  • Syneos Health offers a Total Self culture with benefits including health coverage, 401k matching, and flexible paid time off.

Matching Summary

The role involves leading the clear and accurate completion of medical writing deliverables for regulatory submissions including NDAs and eCTDs.

Salary

Base: $80,600.00 - $145,000.00; Bonus/Equity: Eligibility to earn commissions/bonus based on performance; Benefits: Medical, Dental, Vision, Company match 401k, ESPP, Flexible PTO

Skills & Requirements

Must-have

  • 5 years lead regulatory writing experience
  • Phase 2 and 3 clinical trial experience
  • Protocol and submission document authoring
  • ICH E3 guideline adherence
  • Clinical Study Report (CSR) development

Nice-to-have

  • Strong project management skills
  • Mentoring less experienced writers
  • Process improvement contributions
  • Client relationship building
  • Statistical analysis plan review

Key Requirements

  • Minimum 5 years lead regulatory writing experience
  • Experience with CTD Modules 2.7.3 and 2.7.4
  • US or Canada work authorization required

Work Rights

Open to US and Canada residents

Tailored Resume

Cover Letter