Senior Scientific Writer - job 2 of 2

Job Summary

A company is looking for a Sr. Scientific Writing Specialist.

Key Responsibilities

• Draft and review submission documents for nonclinical pharmacology, including eCTD summaries and study reports
• Independently author nonclinical documents for submission to health authorities worldwide
• Adhere to timelines for document preparation and maintain compliance with GxP and regulatory guidelines

Required Qualifications

• PhD with 0-2 years of scientific writing experience preferred, or BS/MS in biology, biochemistry, or life sciences with 5-7 years of experience
• Experience as a nonclinical writer for regulatory submission documents
• Familiarity with Module 2 or Investigative Brochures (nonclinical components)
• Basic understanding of eCTD and drug development process is a plus
• Proficiency in Word, Excel, Adobe, and related software