Remote CMC Tech Writer & Analytical SME – 12-Month Contract

Tundra Technical Solutions; Ridgefield (CT); On-site; USD 100,000 - 130,000; Full time

Job summary

Tundra Technical Solutions seeks an experienced Analytical SME & CMC Technical Writer to support drug substance and product development programs. This fully remote position requires strong expertise in analytical development, CMC documentation, and regulatory submissions.

Responsibilities include authoring CTD Module 3 documentation, collaborating with internal and external partners, and managing documentation workflows in Veeva RIM. Candidates should have over six years of experience in pharmaceutical/biotech sectors.

Qualifications

• 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).

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.

Skills

CMC technical writing

Regulatory documentation

Strong communication

Cross-functional collaboration

Tools

Veeva RIM

Job description

Tundra Technical Solutions seeks an experienced Analytical SME & CMC Technical Writer to support drug substance and product development programs. This fully remote position requires strong expertise in analytical development, CMC documentation, and regulatory submissions.

Responsibilities include authoring CTD Module 3 documentation, collaborating with internal and external partners, and managing documentation workflows in Veeva RIM. Candidates should have over six years of experience in pharmaceutical/biotech sectors.