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

SyneosHealth

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 the completion and review of a variety of regulatory medical writing deliverables, ensuring clarity, accuracy, and adherence to guidelines while mentoring junior writers and collaborating with multiple departments.
  • Benefits include health coverage, 401k match, employee stock purchase plan eligibility, commissions/bonus potential, flexible paid time off, and a supportive culture emphasizing career development and diversity.

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 based on performance; Benefits: Medical, Dental, Vision, 401k match, Employee Stock Purchase Plan, 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
  • Adherence to regulatory standards
  • Mentoring less experienced writers

Nice-to-have

  • Collaboration with cross-functional teams
  • Technical support and training provision
  • Experience with clinical literature searches
  • Ability to work within budgeted hours
  • Strong client interaction skills
  • Commitment to diversity and inclusion culture

Key Requirements

  • Experience in medical writing for late phase clinical trials
  • Familiarity with regulatory guidelines and templates
  • Ability to manage multiple documents and reviews
  • Experience with clinical study reports and protocols
  • Less than 25% travel availability

Work Rights

Not specified

Tailored Resume

Cover Letter