Principal Medical Writer - Regulatory Submission Documents

Syneos Health

Base: $95,000.00 - $175,700.00; bonus/equity: not ...
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3-5 years of relevant experience
Strong understanding of fda regulations
Experience writing regulatory documents
** Syneos Health is seeking a Principal Medical Writer for regulatory submission documents, responsible for creating a range of clinical documentation while ensuring compliance with regulatory standards. The ideal candidate will have 3-5 years of relevant writing experience and a strong understanding of FDA and ICH regulations. **

Job Summary

  • Syneos Health is dedicated to accelerating customer success in drug development.
  • The role involves leading medical writing deliverables with minimal supervision.
  • Employees enjoy a supportive environment with opportunities for career development.

Matching Summary

Match Score: 75

** Syneos Health is seeking a Principal Medical Writer for regulatory submission documents, responsible for creating a range of clinical documentation while ensuring compliance with regulatory standards. The ideal candidate will have 3-5 years of relevant writing experience and a strong understanding of FDA and ICH regulations. **

Salary

Base: $95,000.00 - $175,700.00; Bonus/Equity: Not specified; Benefits: Health benefits, 401k match, flexible PTO

Skills & Requirements

Must-have

  • 3-5 years of relevant experience
  • Strong understanding of FDA regulations
  • Experience writing regulatory documents

Nice-to-have

  • Strong presentation and interpersonal skills
  • Ability to mentor less experienced writers
  • Commitment to inclusive culture

Key Requirements

  • Bachelor's degree in relevant discipline
  • Graduate degree preferred
  • Extensive knowledge of English grammar

Work Rights

Not specified

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