Principal Medical Writer - Regulatory Submission Documents

SyneosHealth

Multiple Locations
Base: $95,000.00 - $175,700.00; bonus/equity: elig...
Medical writing for regulatory submissions
Knowledge of fda and ich regulations
Clinical study document preparation
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success by partnering with innovators across the drug development continuum

Job Summary

  • Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success by partnering with innovators across the drug development continuum.
  • The role involves leading the completion of various medical writing deliverables, coordinating cross-departmental activities, and ensuring adherence to regulatory standards and quality reviews.
  • The company offers benefits including health coverage, 401k match, employee stock purchase plan, commissions/bonus opportunities, flexible paid time off, and a supportive, inclusive culture.

Matching Summary

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success by partnering with innovators across the drug development continuum.

Salary

Base: $95,000.00 - $175,700.00; 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 for regulatory submissions
  • Knowledge of FDA and ICH regulations
  • Clinical study document preparation
  • Project and time management skills
  • Strong proficiency in MS Office
  • Medical terminology and clinical research knowledge

Nice-to-have

  • Collaborative and interpersonal skills
  • Presentation and proofreading skills
  • Mentoring less experienced writers
  • Experience with AMA Manual of Style
  • Ability to interpret and present clinical data

Key Requirements

  • Bachelor's degree in relevant discipline
  • 3-5 years relevant medical/scientific writing experience
  • Experience in biopharmaceutical or CRO industry
  • Strong understanding of FDA and ICH regulations
  • Experience writing regulatory document types

Work Rights

Not specified

Tailored Resume

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