Associate Director, Medical Writing

Calicolabs

South San Francisco, CA, United States
Base: $230,000 - $240,000; bonus/equity: two annua...
On-site
Clinical and regulatory document leadership
Cross-functional collaboration
Vendor management for external writers
Provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory documents

Job Summary

  • Provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory documents.
  • Develop medical writing best practices, including standard timelines, clinical document templates, and a Calico Style Guide.
  • Partner with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes.

Matching Summary

Provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory documents.

Salary

Base: $230,000 - $240,000; Bonus/Equity: Two annual cash bonuses; Benefits: Not specified

Skills & Requirements

Must-have

  • Clinical and regulatory document leadership
  • Cross-functional collaboration
  • Vendor management for external writers
  • Develop medical writing best practices
  • ICH compliance and SOP development
  • Expertise in clinical regulatory documents

Nice-to-have

  • Curiosity-driven discovery science
  • Inspiring and exciting work environment
  • Positive can-do attitude
  • Ability to roll up sleeves

Key Requirements

  • Master's degree in life science discipline (PharmD or PhD preferred)
  • 8+ years of scientific or medical writing experience
  • Expert knowledge of clinical regulatory documents and requirements
  • Experience with Microsoft Office Suite, Adobe Acrobat, SharePoint, and Veeva RIM
  • Experience in resource planning and management of contractors

Work Rights

Not specified

Tailored Resume

Cover Letter