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

SyneosHealth

Multiple Locations, , US
Base: $80,600.00 - $145,000.00; bonus/equity: elig...
Fully remote
Regulatory medical writing
Lead writing experience
Phase 2 and 3 clinical trials
Syneos Health is a 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 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 of a variety of regulatory medical writing documents while ensuring adherence to regulatory standards and coordinating reviews across departments.
  • The company offers benefits including health coverage, 401k match, employee stock purchase plan, commissions/bonuses, flexible paid time off, and supports a culture of career development and diversity.

Matching Summary

Syneos Health is a 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

  • Regulatory medical writing
  • Lead writing experience
  • Phase 2 and 3 clinical trials
  • Project management skills
  • Client interaction experience
  • Time management skills

Nice-to-have

  • Mentoring less experienced writers
  • Technical training and consultation
  • Process improvement contributions
  • Remote work flexibility
  • Diversity and inclusion culture

Key Requirements

  • Minimum 5 years lead regulatory writing experience
  • Experience with protocols, CSRs, IBs, and safety reports
  • Strong project management and client experience
  • Work authorization for US or Canada

Work Rights

Not specified

Tailored Resume

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