Analytical SME & CMC Technical Writer

About

We are seeking an experienced Analytical SME & CMC Technical Writer to support drug substance (DS) and drug product (DP) development programs within a fast-paced pharmaceutical environment.

This role is ideal for someone with a strong background in analytical development, CMC documentation, regulatory submissions, and technical writing within biotech/pharma.

Key Responsibilities:

• Support DS/DP analytical development, QC, stability programs, and control strategies
• Author/review CTD Module 3 documentation and analytical sections for global regulatory submissions
• Collaborate with internal teams and external CDMOs/CROs
• Review protocols, reports, specifications, quality agreements, and stability data
• Manage documentation workflows within Veeva RIM

Required Qualifications:

• PhD required
• 6+ years of pharmaceutical/biotech CMC and analytical development experience
• Strong experience with regulatory submissions and technical writing
• Familiarity with GMP and global regulatory guidelines (ICH, FDA, EMA, USP, EP)
• Experience supporting solid and liquid formulations

Preferred:

• Experience with IND, CTA, NDA, or MAA submissions
• Experience working with external manufacturing/testing partners

Top Skills:

• Analytical development & QC expertise
• CMC technical writing and regulatory documentation
• Strong communication and cross-functional collaboration

Additional Details:

• Fully Remote
• 12-month contract
• Interview process includes video interview + panel interview

Interested candidates are encouraged to apply with an updated resume.