Senior Principal Medical Writer

beonemedicines.se

Base: $137,100.00 - $182,100.00 annually; bonus/eq...
Advanced degree in life science or pharmacy
3+ years regulatory document writing experience
Proficiency in microsoft word and adobe acrobat
This position is responsible for providing expertise to support the development of high-quality clinical and regulatory documents to facilitate speed of information during product development and submission

Job Summary

  • This position is responsible for providing expertise to support the development of high-quality clinical and regulatory documents to facilitate speed of information during product development and submission.
  • The role involves managing multiple complex documents simultaneously while proactively identifying risks and developing mitigation plans for NDA/BLA/MAA submissions.
  • BeOne Medicines offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), Life Insurance, Paid Time Off, and opportunities for discretionary equity awards.

Matching Summary

This position is responsible for providing expertise to support the development of high-quality clinical and regulatory documents to facilitate speed of information during product development and submission.

Salary

Base: $137,100.00 - $182,100.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Comprehensive package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO

Skills & Requirements

Must-have

  • Advanced degree in life science or pharmacy
  • 3+ years regulatory document writing experience
  • Proficiency in Microsoft Word and Adobe Acrobat
  • Experience with INDs, NDAs, BLAs, MAAs submissions
  • Ability to manage complex clinical documents

Nice-to-have

  • Mentoring full-time employees and contractors
  • Leading cross-functional process optimization
  • Participating in DIA meetings and communities
  • Strong analytical thinking and data analysis skills
  • Demonstrating entrepreneurial mindset

Key Requirements

  • MS/PhD/PharmD/MD in life science preferred
  • BS with minimum 7 years regulatory writing experience
  • Masters with 5+ years or PhD with 3+ years experience
  • Technical expertise in electronic document management systems

Work Rights

Not specified

Tailored Resume

Cover Letter