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

Syneos Health

Multiple Locations
Base: $80,600.00 - $145,000.00; bonus/equity: elig...
Medical writing of regulatory documents
Knowledge of ich e3 guidelines
Coordination of medical writing activities
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by placing the patient and customer at the center of clinical development

Job Summary

  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by placing the patient and customer at the center of clinical development.
  • The role involves leading and managing the completion of a variety of complex medical writing deliverables, ensuring adherence to regulatory standards and quality requirements while collaborating with cross-functional teams.
  • Employees benefit from a supportive culture promoting career development, flexible paid time off, health benefits, company match 401k, and eligibility for bonuses and stock purchase plans.

Matching Summary

Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by placing the patient and customer at the center of clinical development.

Salary

Base: $80,600.00 - $145,000.00; Bonus/Equity: Eligibility to earn commissions/bonus and participate in Employee Stock Purchase Plan; Benefits: Medical, Dental, Vision, Company match 401k, flexible PTO and sick time

Skills & Requirements

Must-have

  • Medical writing of regulatory documents
  • Knowledge of ICH E3 guidelines
  • Coordination of medical writing activities
  • Review of statistical analysis plans
  • Client interaction and collaboration

Nice-to-have

  • Mentoring less experienced writers
  • Technical support and training
  • Experience with clinical literature searches
  • Ability to work within budgeted hours
  • Adaptability to diverse teams and cultures

Key Requirements

  • Experience with clinical study protocols and reports
  • Familiarity with regulatory submission documents
  • Understanding of ICH E3 and regulatory guidelines
  • Ability to lead document reviews and resolve client comments
  • Minimal travel availability (less than 25%)

Work Rights

Not specified

Tailored Resume

Cover Letter