Senior Medical Writer - Regulatory Documents - Csr /protocol - Late Phase

Syneos Health

Base: $80,600.00 - $145,000.00; bonus/equity: elig...
**
Clinical study protocol writing
Clinical study report authoring
Ich e3 guideline adherence
** Syneos Health is seeking a Senior Medical Writer with expertise in regulatory documents for late-phase clinical trials. The ideal candidate will be responsible for leading the completion of various medical writing deliverables, ensuring adherence to regulatory standards, while benefiting from a supportive company culture and comprehensive employee benefits. **

Job Summary

  • The role leads the clear and accurate completion of medical writing deliverables ensuring scientific information is presented clearly.
  • Candidates will manage medical writing activities for various documents including clinical study reports, protocols, and NDA submissions while adhering to ICH E3 guidelines.
  • Syneos Health offers a comprehensive benefits package including health coverage, 401k matching, and flexible paid time off.

Matching Summary

Match Score: 75

** Syneos Health is seeking a Senior Medical Writer with expertise in regulatory documents for late-phase clinical trials. The ideal candidate will be responsible for leading the completion of various medical writing deliverables, ensuring adherence to regulatory standards, while benefiting from a supportive company culture and comprehensive employee benefits. **

Salary

Base: $80,600.00 - $145,000.00; Bonus/Equity: Eligibility for commissions/bonus based on performance; Benefits: Company car or allowance, Medical/Dental/Vision, 401k match, ESPP

Skills & Requirements

Must-have

  • Clinical study protocol writing
  • Clinical study report authoring
  • ICH E3 guideline adherence
  • Regulatory submission experience
  • Statistical analysis plan review

Nice-to-have

  • Mentoring less experienced writers
  • Collaborating with cross-functional teams
  • Developing deep industry expertise
  • Agile problem-solving approach
  • Total Self culture alignment

Key Requirements

  • Experience with late-phase clinical trials
  • Knowledge of FDA and EMA regulatory requirements
  • Ability to work within budgeted hours

Work Rights

Not specified

Tailored Resume

Cover Letter